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Clinical research associate jobs in District of Columbia - 30 jobs

  • Clinical Associate / Staff Pathologist

    Johns Hopkins University 4.4company rating

    Clinical research associate job in Washington, DC

    General Description The Pathology Department is seeking a full-time Clinical Associate/Staff Pathologist for Sibley Memorial Hospital, Washington, DC, with experience in anatomic and clinical pathology (AP/CP). The pathologist shall provide services to Johns Hopkins patients in a competent, full, and complete manner consistent with the quality of care of prevailing medical practice. The physician shall exercise independent medical judgment consistently with approved methods and practices in the Pathologist's specialty and in the best interest of the patients. Responsible for assigned cases, patient result sign-out, medical records, Peer Review Activity, and regulatory oversights. An individual may also support Administrative Services, Teaching, and Research. The pathologist also provides medical direction and other administrative and management services, including utilization review and quality assurance programs, as required by governmental and quasi-governmental agencies or JHU. Qualifications MD, DO, or MD/PhD degree, with board certification or board eligibility in Anatomic and Clinical Pathology. Additional specialty training in one or two areas of pathology (e.g. Gyn, GI, GU, Cyto) is preferred. Licensure: Physician shall be qualified, professionally competent, and duly licensed to practice medicine in the State of Maryland and the District of Columbia and shall complete requirements for obtaining and maintaining licensure, including successful completion of required background checks. The physician shall obtain and maintain a current registration with the following, as applicable: Federal Drug Enforcement Administration, the Maryland State Division of Drug Control, the District of Columbia Department of Health Pharmaceutical Drug Control Division, and/or other applicable agencies of the State of Maryland and the District of Columbia. Physician represents that as of the Start Date, he/she is not subject to, or threatened with any investigation, censure, probation, suspension, or other adverse action with respect to his/her medical license in any jurisdiction. Physicians shall maintain membership with the medical staff at the assigned facilities, holding unrestricted privileges. Application Instructions Interested individuals should upload their CV, a brief statement of interest, and the names of three references To apply for this position, visit: apply.interfolio.com/179842 Salary Range The referenced salary range represents the minimum and maximum salaries for this position and is based on Johns Hopkins University's good faith belief at the time of posting. Not all candidates will be eligible for the upper end of the salary range. The actual compensation offered to the selected candidate may vary and will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, internal equity, market conditions, education/training and other factors, as reasonably determined by the University. Total Rewards Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: benefits-worklife/. Equal Opportunity Employer The Johns Hopkins University is committed to equal opportunity for its faculty, staff, and students. To that end, the university does not discriminate on the basis of sex, gender, marital status, pregnancy, race, color, ethnicity, national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status or other legally protected characteristic. The university is committed to providing qualified individuals access to all academic and employment programs, benefits and activities on the basis of demonstrated ability, performance and merit without regard to personal factors that are irrelevant to the program involved. Pre-Employment Information If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at [emailprotected]. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit accessibility.jhu.edu. Background Checks The successful candidate(s) for this position will be subject to a pre-employment background check including education verification. EEO is the Law: Vaccine Requirements Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. For additional information, applicants for SOM positions should visit coronavirus/covid-19-vaccine/ and all other JHU applicants should visit health-safety/covid-vaccination-information/. The following additional vaccine requirements may apply, depending upon your campus. Please contact the hiring department for more information. The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
    $103k-194k yearly est. 2d ago
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  • Clinical Scientist

    Eliassen Group 4.7company rating

    Clinical research associate job in Washington, DC

    **Anywhere** **Type:** Permanent **Category:** Clinical Ops **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN -112025-104407 **Shortcut:** ********************************** + Description + Recommended Jobs **Description:** _Remote_ Our client is a PE-backed medical device organization advancing next-generation technologies in atrial fibrillation and cardiac ablation. As the team prepares for two global Class III IDE studies, the Clinical Development and Science function is expanding to support protocol development, safety oversight, and scientific leadership. The role provides exposure to electrophysiology and Pulse Field Ablation, contributing to the scientific, clinical, and strategic elements of cardiac ablation innovation. _This is a full-time, permanent opportunity, offering a competitive salary and comprehensive benefits package. Qualified applicants must be willing and able to work on a w2 basis._ Salary: $130,000 - $150,000/ yr. w2 **Responsibilities:** **Responsibilities** + Lead development of clinical study protocols, case report forms, and associated study documents. + Support clinical safety oversight, including adverse event review, vigilance, and coordination with the Clinical Events Committee. + Contribute scientific input into study design, endpoints, and overall clinical strategy. + Review and interpret clinical data to support study reports, publications, and regulatory submissions. + Collaborate closely with Clinical Operations, Field Clinical, Regulatory, and Quality teams. + Participate in discussions with key opinion leaders, investigator meetings, and internal scientific reviews. + Ensure scientific consistency across programs and alignment with regulatory and clinical goals. + Support the development of data collection tools and ensure clarity, accuracy, and completeness. + Assist with medical writing elements related to clinical reports and study documentation. **Experience Requirements:** **Experience Requirements** + Electrophysiology and Pulse Field Ablation experience required. + Background supporting clinical studies in industry or academia. + Strong understanding of clinical research methods and safety reporting. + Ability to evaluate and interpret clinical data. + Strong scientific writing skills and attention to detail. + Ability to collaborate effectively across Clinical Development, Operations, and Regulatory functions. + Excellent communication and analytical capabilities. + Prior experience as a Clinical Scientist in medical devices preferred. + Experience with Class III devices or IDE studies preferred. + Experience contributing to regulatory submissions or interacting with health authorities preferred. + Experience working with electrophysiologists, key opinion leaders, or clinical event committees preferred. **Education Requirements:** **Education Requirements** + MS, PhD, or MD. **_Recruitment Transparency Notice_** **_Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (_** **_noreply@eliassen.com_** **_, ************* inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process._** _Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range._ _W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality._ _Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact_ _********************_ _._ _About Eliassen Group:_ _Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate._ _Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status._ _Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!_
    $130k-150k yearly 6d ago
  • Sr. Clinical Research Associate - Oncology - FSP

    Parexel 4.5company rating

    Clinical research associate job in Washington, DC

    The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Monitoring Responsibilities and Study Conduct:** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk:** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Skills:** + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) + Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases + Must be fluent in English and in the native language(s) of the country they will work in + Ability to travel 60-80% + Valid driver's license and passport required **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
    $82k-110k yearly est. 42d ago
  • Trial Master File (TMF) Specialist Oncology

    Sumitomo Pharma 4.6company rating

    Clinical research associate job in Washington, DC

    Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $72.5k-90.6k yearly 60d+ ago
  • Study Coordinator

    Howard University 4.4company rating

    Clinical research associate job in Washington, DC

    The Talent Acquisition department hires qualified candidates to fill positions which contribute to the overall strategic success of Howard University. Hiring staff “for fit” makes significant contributions to Howard University's overall mission. At Howard University, we prioritize well-being and professional growth. Here is what we offer: Health & Wellness: Comprehensive medical, dental, and vision insurance, plus mental health support Work-Life Balance: PTO, paid holidays, flexible work arrangements Financial Wellness: Competitive salary, 403(b) with company match Professional Development: Ongoing training, tuition reimbursement, and career advancement paths Additional Perks: Wellness programs, commuter benefits, and a vibrant company culture Join Howard University and thrive with us! *************************************** JOB PURPOSE: To coordinate study participants in the Clinical Trials Unit. Execute tasks as required by the study protocols. SUPERVISORY AUTHORITY: Involves no responsibility or authority for the direction of others. NATURE AND SCOPE: Interacts with physicians, immediate staff members, research participants, and the general public. PRINCIPAL ACCOUNTABILITIES: Maintain familiarity with the protocol. Evaluate study candidates for eligibility into the study. Meet with the patient's caretaker to review the details of study enrollment. Assure that informed consent has been obtained from the patient's legal guardian and consent from the patient when applicable prior to the initiation of research-related activities. Schedule tests and appointments for patients within appropriate timeframes. Send the prescriptions for study medication to the research pharmacist, including the height, weight or body surface area. Identifying abnormal laboratory results and obtain repeat evaluations are required by the protocol. Complete case report forms accurately and thoroughly and enter data electronically. Maintain source documentation in shadow files for each study participant. Respond to date inquiries in a timely manner. Complete Serious Adverse Even Reports within the proper timeframes. Report to the Project Director and the Principal Investigator regarding assignments and duties. Perform other duties as instructed by the Principal Investigator and Project Director. CORE COMPETENCIES: Knowledge of clinical trials protocols. Knowledge of management regulations of Howard University. Knowledge of the educational and research goals of grant. Knowledge of federal and Howard University grant policies, administration and regulation. Excellent skill in the operation of desktop computer and software applications to include e-mail and calendar functionality, word processing, spreadsheet applications and presentation software. Competence in both oral and written English to communicate in a clear and concise manner. Ability to establish and maintain effective and harmonious work relations with faculty, staff, students and customers. MINIMUM REQUIREMENTS: Minimum of a Bachelor of Science degree. Course study concentration in a health-related field is desirable. Compliance Salary Range Disclosure $50,000-$60,000
    $50k-60k yearly Auto-Apply 60d+ ago
  • HIV - Sr. Clinical Research Coordinator

    Children's National 4.6company rating

    Clinical research associate job in Washington, DC

    HIV - Sr. Clinical Research Coordinator - (25000341) Description The Senior Clinical Research Coordinator independently leads day-to-day operations of clinical research studies conducted by a principal investigator with limited supervision. In addition, the individual performs a variety of complex duties involved in the collection, compilation, documentation and analysis of clinical research data. The Senior Clinical Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. This individual may support multiple investigators with clinical and translational research projects and direct the work of a Clinical Research Assistant and Clinical Research Coordinator as assigned. Works under supervision of PI on the full lifecycle of clinical research studies focusing on HIV treatment and prevention. Will recruit and consent adolescents and young adults with HIV and those who may benefit from HIV and STI prevention in the community as well as outpatient and inpatient clinical settings on a weekly basis. Liaises directly with team members, PI, CNH IRB, and study-related personnel to monitor program implementation and evaluation. Prepares documents for study progress reports, audits and regulatory filing. Maintains relevant study databases and verifies the accuracy through quality management. Coordinates study visits with internal partners and participants. Supports data initiatives for other projects as needed, identifying opportunities for improving data management. Gathers documentation and prepares performance data for sponsor assessments and audits. Participates in multidisciplinary team meetings. Qualifications Minimum EducationB. A. /B. S. degree in a science, technical, health-related field or other applicable discipline with at least 3 years of relevant experience (Required) OrMaster's Degree Master's degree with at least 2 years of relevant experience (Required) Minimum Work ExperienceAt least 3 years of experience with a bachelor's degree. (Required) OrAt least 2 years of experience with a master's degree. (Required) Required Skills/KnowledgeKnowledge of clinical research designs and needed infrastructure. Familiarity with databases, data collection tools and data analysis methods. Ability to manage multiple complex activities while maintaining close attention to detail and not losing sight of the organizational mission. Interpersonal skills that demonstrate formal and informal leadership in a diverse professional environment. Required Licenses and CertificationsInternal candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification. Upon Hire (Required) External candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification within one year of hire. 1 Year (Required) Functional AccountabilitiesResponsible Conduct of Research Consistently demonstrates adherence to the standards for the responsible conduct of research. Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator. Stays informed of and adheres to institutional policies, and federal regulations (e. g. Titles 21 and 45 of the Code of Federal Regulations) and guidances (International Counsel on Harmonization) regarding human subjects' research and use of protected health information. Uses research funds and resources appropriately. Maintains confidentiality of data as required. Meets all annual job-related training and compliance requirements. Research Administration Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility. Accurately creates, completes, maintains, organizes and accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives. Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned. Attends study meetings, which could include overnight travel, as requested by principal investigator. Works well with other members of the research team, appreciates a diverse workplace and seeks and provides input when appropriate. Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center. Identifies and resolves issues and challenges with appropriate input and oversight. Reviews journals, abstracts and scientific literature to obtain information relevant to clinical research programs. Creates standard operating procedures (SOPs), and implements operational plans. Provides oversight and training to study team members for a variety of studies. Develops study documents, including consent forms and protocols. Participant Enrollment Adheres to the IRB-approved recruitment plan. Screens subjects for eligibility per the protocol and institutional policies. Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies. Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest. Engages participants/LARs in the informed consent process according to institutional policies. Study Management Conducts/participates in feasibility assessments to ensure adequate site resources and infrastructure are available for protocol participation. Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member. Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies. Authors study submissions and related documents based on functional role; this may include IRB contingency responses, ClinicalTrials. gov postings, Certificate of Confidentiality applications and scholarly presentations and publications. Registers and records participant visits in the appropriate tracking system. Anticipates study needs and subject caseload to meet organizational objectives and deadlines in a timely manner. Coordinates, prepares for and responds to routine oversight body visits and audits. Independently authors reports to oversight bodies and/or trains and oversees staff performing these tasks. Data Collection Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete). Ensures that queries are resolved within sponsor and institutional timelines. Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation. Ensures secure storage of study documents. Anticipate and responds to customer needs; follows up until needs are met Teamwork/CommunicationDemonstrate collaborative and respectful behavior Partner with all team members to achieve goals Receptive to others' ideas and opinions Performance Improvement/Problem-solving Contribute to a positive work environment Demonstrate flexibility and willingness to change Identify opportunities to improve clinical and administrative processes Make appropriate decisions, using sound judgment Cost Management/Financial ResponsibilityUse resources efficiently Search for less costly ways of doing things SafetySpeak up when team members appear to exhibit unsafe behavior or performance Continuously validate and verify information needed for decision making or documentation Stop in the face of uncertainty and takes time to resolve the situation Demonstrate accurate, clear and timely verbal and written communication Actively promote safety for patients, families, visitors and co-workers Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance Primary Location: District of Columbia-WashingtonWork Locations: CN Hospital (Main Campus) 111 Michigan Avenue NW Washington 20010Job: ResearchOrganization: Ctr Clinical & Community RsrchPosition Status: R (Regular) - FT - Full-TimeShift: DayWork Schedule: Mon-FriJob Posting: Nov 17, 2025, 3:54:14 PMFull-Time Salary Range: 54516. 8 - 90854. 4
    $59k-76k yearly est. Auto-Apply 1d ago
  • Clinical

    Vanda Pharmaceuticals 4.5company rating

    Clinical research associate job in Washington, DC

    Education & Experience Requirements: Undergraduate or graduate degree in Biology, Medicine, Health Sciences or related field, with a strong academic record Exposure to basic sciences/clinical research Excellent oral and written communication skills, self-motivation, and ability to adapt within a dynamic environment Must be able to perform the essential functions of the position, with or without reasonable accommodation; however, reasonable accommodations will be provided for qualified individuals with disabilities unless doing so would impose undue hardship. The total compensation package for this position will also include incentive compensation and benefits such as health insurance, unlimited paid time off, parental leave, a 401k matching program, and other benefits to its employees. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation, protected veteran status, or any other characteristic protected by law. If you reside in a state or locality with enacted pay transparency laws, you are entitled to request and receive additional details regarding compensation and benefits. For assistance, please contact us at ************ between 8:00 AM and 5:30 PM ET, Monday through Friday.
    $55k-83k yearly est. 60d+ ago
  • Clinical Territory Associate - Future Opportunity

    Intuitive Surgical 4.9company rating

    Clinical research associate job in Washington, DC

    At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care. Job Description * Please note: Candidates must live within or be willing to relocate to the Washington, DC area to perform the duties of this role. Primary Function of Position The Clinical Territory Associate (CTA) is a 24+ month developmental role that will partner with the Washington, DC team to gain knowledge in all aspects of our business to include technical, clinical, and sales. Essential Job Duties (Specific responsibilities and tasks an individual would be expected to perform in the role. Additional job duties may be determined by functional people manager) * Assists sales representatives with surgeon trainings, hospitals robotic development, and overall territory management * Guides technical in-services for customers to include OR staff, surgeons, etc. * Sells benefits of advanced technology to existing robotic users to contribute to team overall quotas * Gains experience in goal setting, mapping, and attaining in preparation for quota bearing role to follow CTA position * Manages administrative tasks: reporting of sales/procedures, outcomes of sales activities, submission of expense reports Qualifications Required Skills and Experience (Specific skills, knowledge, and experience that an individual must possess in order to successfully perform in job) * Minimum 1-year leadership (military) experience or 1 year of outside sales experience required * Ability to travel up to 25%, and work nights and weekends as needed Required Education and Training (As applicable - Specific education and training that an individual must possess in order to successfully perform in job) * Bachelor's degree required Working Conditions (As applicable - Any physical requirements for the job. If not applicable, state "none") * None Preferred Skills and Experience (As applicable - Specific skills, knowledge, and experience that are not required to perform the job, but are desirable to have) * Proven record of success * Ambition and exceptional work ethic * Ability to excel in a high-energy, fast-paced environment * Excellent interpersonal skills and persuasive communication skills * Proven ability to work effectively as part of a team Additional Information Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed. Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. Mandatory Notices U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target base compensation ranges are listed.
    $82k-135k yearly est. 2d ago
  • Clinical Research Medical Director, Cardiometabolic

    Amgen 4.8company rating

    Clinical research associate job in Washington, DC

    **Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **Clinical Research Medical Director, Cardiometabolic** **What you will do** Let's do this. Let's change the world. In this vital role you will support the development, execution and communication of the global scientific/medical evidence plan. Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program. Support the development of key scientific external relationships with opinion leaders. Participate and providing clinical input into safety and regulatory interactions. + Provide clinical/scientific input during the development and execution of clinical trials + Interpret clinical trial data + Participate in safety assessments + Participate in interactions with regulatory agencies + Author CSRs, publications and regulatory submissions + Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL + Identify new clinical research opportunities + Support in-licensing and out-licensing activities and partner relationships + Support product lifecycle management for new indications as directed by Global Development Leader + Provide clinical content input to: regulatory interactions and documents, safety interactions and documents, materials to be used in Scientific Affairs, and materials to be used by the Commercial Organization **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. **Basic Qualifications:** MD or DO degree from an accredited medical school AND 2 years of clinical research experience and/or basic science research **Preferred Qualifications:** + Three (3) or more years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) + Five or more years of clinical research experience and/or basic science research combined with clinical instructing and patient care activities + Strong and versatile clinical development experience in endocrinology or cardiology and accreditation in relevant sub-specialty + Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes + Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 1, 2 and/or 3 clinical trials in obesity or diabetes + Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements + Leadership experience/potential as a medical expert in a complex matrix environment + Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication + Strong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution path **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: + A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts + A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan + Stock-based long-term incentives + Award-winning time-off plans + Flexible work models, including remote and hybrid work arrangements, where possible **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. **Application deadline** Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. **Sponsorship** Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
    $112k-158k yearly est. 60d+ ago
  • Clinical Research Coordinator (DCR)

    Davita 4.6company rating

    Clinical research associate job in Washington, DC

    Posting Date 12/23/20254 Bradley Park DrSte 2b, Columbus, Georgia, 31904-3655, United States of America At DaVita Clinical Research, we find that our best leaders are those who create an inspiring vision, have a desire to shape the future of medicine, and empower their team to achieve success. They enjoy tackling difficult problems and believe that the best way to solve them is through a collaborative environment that involves team efforts. They take ownership of results and instill accountability in those they lead. They are driven, compassionate, strong communicators, relationship builders, and find real fulfillment in challenging and impactful work. Do you love patient care? Are you a LPN or RN, but are tired of the demands of working in a healthcare setting? Have you ever explored using your clinical skills differently? Clinical Research allows a more flexible schedule for healthcare providers interested in a dynamic and fast paced environment that is on the cutting edge of medicine. Sound like you? Then you might be a great fit for a Clinical Research Coordinator role with DaVita Clinical Research (DCR) We are looking for a highly motivated, positive and innovative Clinical Research Study Coordinator (Research Coordinator) to lead in the coordination, management and conduct of nephrology clinical research trials in dialysis centers and physicians practices. DaVita Clinical Research (DCR) is a Renal Research site network conducting clinical trials across the country. DCR prides itself on a culture of growth, transparency and feedback and would want our leaders to do that same. We want a teammate who is compassionate, purposeful and motivated by meaningful work. This position will be based in our Montgomery, AL site and coordinate and execute all aspects of late phase clinical trials in the Montgomery and surrounding areas. Based on business needs, a flexible weekly work schedule may be available. ESSENTIAL DUTIES & RESPONSIBILITIES: Accountable for the successful execution of clinical trials through all phase of the study: enrollment, maintenance and close out. Responsible for performing research procedures according to the study protocol and working in partnership with the physician investigator to coordinate research activities. Serves as a liaison between the physicians (Principal Investigator or Sub-Investigator), study sponsors and DaVita facility teammates. Responsible to deliver or exceed project enrollment targets for clinical research studies at their site. Responsible for accurate and timely data entry into the electronic data entry systems. Responsible for timely resolution of all data queries to meet project timelines for database lock. Demonstrates compliance with good clinical practice (GCP) and applicable law, and verifies that study teams comply with GCP and applicable law. Demonstrates adherence to DCR standard operating procedures and policies and with the standards customary in the clinical research industry. Understands and promotes compliance with all applicable healthcare and research regulations. MINIMUM QUALIFICATIONS High School Diploma or equivalent is required. Bachelor's Degree is preferred. Minimum 1 year of clinical research experience managing studies from start up to close out or equivalent experience. Reliable transportation to travel between local research sites. Fluency in Spanish (spoken and written) is preferred. Commitment to and role model of DaVita's values with ability to demonstrate those positively and proactively to patients, teammates, management, physicians, and/or vendors (Village Service Partners) in everyday performance and interactions. Ability to manage multiple projects, meet deadlines, and adjust priorities appropriately in an evolving work environment with shifting time frames; self-starter with high degree of initiative, urgency, and follow through. Experience in managing confidential information and/or issues using discretion and Judgment Certified Clinical Research Coordinator (SOCRA or ACRP) - preferred DaVita Clinical Research (DCR), a wholly owned subsidiary of DaVita Inc., is the research arm of DaVita. DCR innovates through retrospective outcomes research aimed at improving care and quality of life for people with kidney disease. DCR assists pharmaceutical and medical device companies in the design, recruitment and completion of clinical trials using its renal research site network. For 30 years we have helped 500+ clients with their development projects. DCR is based in Minneapolis, MN and operates in locations across the US. What We'll Provide: More than just pay, our DaVita Rewards package connects teammates to what matters most. Teammates are eligible to begin receiving benefits on the first day of the month following or coinciding with one month of continuous employment. Below are some of our benefit offerings. Flexible weekly work schedule: This will vary and is based on current business needs December Industry wellness break (Week between Christmas and New Year's Day) Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out Support for you and your family: Family resources, EAP counseling sessions, access Headspace , backup child and elder care, maternity/paternity leave and more Professional development programs: DaVita offers a variety of programs to help strong performers grow within their career and also offers on-demand virtual leadership and development courses through DaVita's online training platform StarLearning. Here is what you can expect when you join our Village: • A "community first, company second" culture based on Core Values that really matter. • Clinical outcomes consistently ranked above the national average. • Award-winning education and training across multiple career paths to help you reach your potential. • Performance-based rewards based on stellar individual and team contributions. • A comprehensive benefits package designed to enhance your health, your financial well-being and your future. • Dedication, above all, to caring for patients suffering from chronic kidney failure across the nation. Join us as we pursue our vision "To Build the Greatest Healthcare Community the World has Ever Seen." Why wait? Explore a career with DaVita today. Go to ************************* to learn more or apply #LI-JD2 At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and comply with state and federal affirmative action requirements. Individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic. This position will be open for a minimum of three days. For location-specific minimum wage details, see the following link: DaVita.jobs/WageRates Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at *********************************** Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.
    $48k-61k yearly est. Auto-Apply 60d+ ago
  • HIV - Sr. Clinical Research Coordinator

    Cnhs 3.9company rating

    Clinical research associate job in Washington, DC

    HIV - Sr. Clinical Research Coordinator - (25000341) Description The Senior Clinical Research Coordinator independently leads day-to-day operations of clinical research studies conducted by a principal investigator with limited supervision. In addition, the individual performs a variety of complex duties involved in the collection, compilation, documentation and analysis of clinical research data. The Senior Clinical Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. This individual may support multiple investigators with clinical and translational research projects and direct the work of a Clinical Research Assistant and Clinical Research Coordinator as assigned. Works under supervision of PI on the full lifecycle of clinical research studies focusing on HIV treatment and prevention. Will recruit and consent adolescents and young adults with HIV and those who may benefit from HIV and STI prevention in the community as well as outpatient and inpatient clinical settings on a weekly basis. Liaises directly with team members, PI, CNH IRB, and study-related personnel to monitor program implementation and evaluation. Prepares documents for study progress reports, audits and regulatory filing. Maintains relevant study databases and verifies the accuracy through quality management. Coordinates study visits with internal partners and participants. Supports data initiatives for other projects as needed, identifying opportunities for improving data management. Gathers documentation and prepares performance data for sponsor assessments and audits. Participates in multidisciplinary team meetings. Qualifications Minimum EducationB. A. /B. S. degree in a science, technical, health-related field or other applicable discipline with at least 3 years of relevant experience (Required) OrMaster's Degree Master's degree with at least 2 years of relevant experience (Required) Minimum Work ExperienceAt least 3 years of experience with a bachelor's degree. (Required) OrAt least 2 years of experience with a master's degree. (Required) Required Skills/KnowledgeKnowledge of clinical research designs and needed infrastructure. Familiarity with databases, data collection tools and data analysis methods. Ability to manage multiple complex activities while maintaining close attention to detail and not losing sight of the organizational mission. Interpersonal skills that demonstrate formal and informal leadership in a diverse professional environment. Required Licenses and CertificationsInternal candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification. Upon Hire (Required) External candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification within one year of hire. 1 Year (Required) Functional AccountabilitiesResponsible Conduct of Research Consistently demonstrates adherence to the standards for the responsible conduct of research. Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator. Stays informed of and adheres to institutional policies, and federal regulations (e. g. Titles 21 and 45 of the Code of Federal Regulations) and guidances (International Counsel on Harmonization) regarding human subjects' research and use of protected health information. Uses research funds and resources appropriately. Maintains confidentiality of data as required. Meets all annual job-related training and compliance requirements. Research Administration Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility. Accurately creates, completes, maintains, organizes and accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives. Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned. Attends study meetings, which could include overnight travel, as requested by principal investigator. Works well with other members of the research team, appreciates a diverse workplace and seeks and provides input when appropriate. Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center. Identifies and resolves issues and challenges with appropriate input and oversight. Reviews journals, abstracts and scientific literature to obtain information relevant to clinical research programs. Creates standard operating procedures (SOPs), and implements operational plans. Provides oversight and training to study team members for a variety of studies. Develops study documents, including consent forms and protocols. Participant Enrollment Adheres to the IRB-approved recruitment plan. Screens subjects for eligibility per the protocol and institutional policies. Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies. Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest. Engages participants/LARs in the informed consent process according to institutional policies. Study Management Conducts/participates in feasibility assessments to ensure adequate site resources and infrastructure are available for protocol participation. Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member. Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies. Authors study submissions and related documents based on functional role; this may include IRB contingency responses, ClinicalTrials. gov postings, Certificate of Confidentiality applications and scholarly presentations and publications. Registers and records participant visits in the appropriate tracking system. Anticipates study needs and subject caseload to meet organizational objectives and deadlines in a timely manner. Coordinates, prepares for and responds to routine oversight body visits and audits. Independently authors reports to oversight bodies and/or trains and oversees staff performing these tasks. Data Collection Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete). Ensures that queries are resolved within sponsor and institutional timelines. Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation. Ensures secure storage of study documents. Anticipate and responds to customer needs; follows up until needs are met Teamwork/CommunicationDemonstrate collaborative and respectful behavior Partner with all team members to achieve goals Receptive to others' ideas and opinions Performance Improvement/Problem-solving Contribute to a positive work environment Demonstrate flexibility and willingness to change Identify opportunities to improve clinical and administrative processes Make appropriate decisions, using sound judgment Cost Management/Financial ResponsibilityUse resources efficiently Search for less costly ways of doing things SafetySpeak up when team members appear to exhibit unsafe behavior or performance Continuously validate and verify information needed for decision making or documentation Stop in the face of uncertainty and takes time to resolve the situation Demonstrate accurate, clear and timely verbal and written communication Actively promote safety for patients, families, visitors and co-workers Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance Primary Location: District of Columbia-WashingtonWork Locations: CN Hospital (Main Campus) 111 Michigan Avenue NW Washington 20010Job: ResearchOrganization: Ctr Clinical & Community RsrchPosition Status: R (Regular) - FT - Full-TimeShift: DayWork Schedule: Mon-FriJob Posting: Nov 17, 2025, 3:54:14 PMFull-Time Salary Range: 54516. 8 - 90854. 4
    $56k-66k yearly est. Auto-Apply 6h ago
  • Senior Coordinator, Institutional Advancement

    Meridian International Center 4.3company rating

    Clinical research associate job in Washington, DC

    Full-time Description Title: Senior Coordinator, Institutional Advancement Employment Status: Non-Exempt Salary: $56,500-60,000 plus bonuses Supervisor Title: Senior Director, Institutional Advancement Date Revised: December 2025 Summary of Position: The Senior Coordinator, Institutional Advancement is a key member of the Institutional Advancement team that supports the giving priorities of Meridian. The position works directly with the Senior Director, Institutional Advancement and senior leaders within the Development team to ensure the smooth operation of business development work and help drive fundraising goals. This position supports the team engaging in frontline fundraising, relationship management, and growth of individual giving programs. The position is responsible for driving renewals, upgrades, and new individual gifts through strategic outreach, moves management, and data-informed fundraising strategies. The Senior Coordinator plays a key role in achieving revenue and renewal goals while ensuring an exceptional donor engagement. This position is located in Washington D.C. and Meridian requires MD, DC, or VA residence for all employees. The position may work partially remotely until further notice. Position Responsibilities: Serve as primary relationship manager for 100+ individual philanthropic partners and prospects Drive the full individual giving membership renewal process, including drafting and sending renewal letters and emails, making follow-up calls, and renewal tracking Research and solicit opportunities for individual membership upgrades, focusing on memberships in the $3,500 - $20,000 annual giving ranges Act as a forward-facing fundraiser to drive new individual philanthropic partners by actively identifying prospects, adding them to the pipeline, cultivating and soliciting with a minimum of three meaningful touch points with new potential partners per week. Welcome and engage new individual and enterprise philanthropic partners to identify interests and maintain accurate contact information Maintain regular communication with philanthropic partners by sharing upcoming event calendars and other relevant organizational updates Support Institutional Advancement fundraising team goals. Responsible for the individual and enterprise giving pipeline in Salesforce and ensuring accurate and timely data entry; Regularly clean and update individual giving accounts and records Support year-end appeal efforts, including drafting appeal language, list segmentation, and gift closing Serve as a Salesforce superuser, supporting strategic and accurate list segmentation for fundraising campaigns Contribute fundraising data and analysis for Development Committee reports Review and provide feedback on event invitation drafts for institutional advancement events Provide initial draft, update, and maintain individual and enterprise giving collateral, including brochures and website content Staff all Institutional Advancement events from setup through cleanup Responsible for completing all organizational administrative responsibilities in a timely manner and meeting all organizational administrative deadlines; other duties as assigned Employer's Statement Meridian is committed to empowering global leaders and amplifying voices of a wide variety of backgrounds to create pathways for greater understanding, shared values, and respect. Connecting people has been our foundation for over 65 years. If you share our values and enthusiasm to promote non-partisan collaboration to address global challenges and opportunities, you can find a home at Meridian. As an equal opportunity employer, Meridian promotes equal employment opportunity to all employees and applicants without regard to race, color, religion, sex, gender identity or expression, sexual orientation, personal appearance, pregnancy, childbirth or related medical condition, family responsibilities, marital, veteran or military status, national origin, age, disability, genetic information, matriculation, political affiliation, or any other classification protected by federal, state, or local law. Equal employment opportunity will be offered and maintained to all persons at every stage and condition of employment, including recruiting, hiring, training, upgrading, promotion, transfer, discipline, layoff, recall, and termination. Meridian offers a comprehensive benefits package including a full medical plan with no deductible, dental (including orthodontics), a retirement plan with a substantial employer contribution from day one, fully paid life, long- and short-term disability, a variety of voluntary benefits, and generous paid leave and holidays. How to Apply Qualified candidates should send resume and cover letter here. Only candidates being considered for this position will be contacted. NO PHONE CALLS in reference to this position will be accepted. Requirements Education/Experience Bachelor's Degree preferred 3-5 years of nonprofit fundraising, with a focus on individual giving, membership giving, and relationship management experience Any equivalent combination of training, education, and experience that demonstrates the ability to perform the essential functions of the position Knowledge, Skills, Abilities: Proven relationship management and frontline fundraising skills Strong written and verbal communication skills Proven ability to manage giving pipelines in Salesforce Highly organized with strong attention to detail and project management skills Self-starter with a proactive, goal-oriented approach Ability to manage multiple priorities in a fast-paced environment Strong inter-cultural communication skills; maturity, cultural sensitivity, and tact suitable for working with individuals from around the world Technical Requirements: Proficiency in Microsoft Office, including Word, Excel, PowerPoint, Outlook, and Teams Advanced experience with CRM systems required; Salesforce experience strongly preferred Experience with list segmentation, pipeline management, and data integrity best practices Salary Description $56,500-60,000 plus bonuses
    $56.5k-60k yearly 29d ago
  • Clinical Research Coordinator II

    Georgetown University 4.6company rating

    Clinical research associate job in Washington, DC

    Georgetown University comprises two unique campuses in the nation's capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world. Requirements Job Overview The Clinical Research Coordinator 2 (CRC2) is responsible for managing and coordinating 7 out of approximately 55 ongoing clinical trials, Phases I-IV, in the Dept. of Neurology, primarily in the disease states of Multiple Sclerosis (MS), Stroke, and Parkinson's Disease. Coordination and management of such studies is both a dynamic and demanding responsibility that requires refined technical, organization, interpersonal, and coordination skills. The CRC2 is responsible for learning the schedule of assessments for each trial, and for coordinating each visit, which involves extensive preparatory work/pre-visit planning described in the "Responsibilities" section. At the time of the visit, the CRC2 is responsible for conducting the entire study visit for each patient, ensuring that the protocol is followed, which requires an in-depth understanding of the intricacies of each individual protocol and patient needs. The CRC2 must maintain a comprehensive functional knowledge of the ancillary departments to be involved in trial visits (e.g., Radiology, CRU, Cardiology) and must be able to communicate and coordinate with such departments effectively. The CRC2 must be capable of performing his/her job maintaining patient confidentiality at all times, and must adhere to the university requirements for the conduct of clinical research. Additional job requirements include, but are not limited to: regulatory maintenance, adherence with ongoing training requirements, accurate reporting of clinical trial visits via the OnCore/CTMS system, accurate and timely data entry, accurate and timely reporting of adverse events, and timely communication with team members and clinical trial sponsors. The CRC II for this position will is responsible for coordinating 7 MS studies which will be conducted at the Georgetown University Hospital Dept. of Neurology main site. The CRC II will spend 5 days per week on site for these trials. The incumbent will spend 5 days per week on site for these trials. The CTM will meet project deadline expectations, be proficient multitasker, patient-oriented and have the ability to prioritize tasks. Work Interactions As an employee of Georgetown University, the CRC II directly supports the University's mission of cura personalis. Clinical Trials offer a unique opportunity for a patient to receive personalized and comprehensive care in a manner that they may not experience otherwise as a patient. Per the requirements of each clinical trial protocol, the CRC II is required to be the main point of contact for a patient in a clinical trial and must respond to inquiries from any patient within 24 hours. The CRC II is instructed and required to maintain regular contact with each patient in their respective trials, because it is an FDA requirement to report adverse events in a timely manner, no matter the severity. As such, clinical trial patients develop close relationships with the CTM/CRC for a trial, which provides unprecedented access to care when necessary. In the overall scheme of the Georgetown University Medical Center, this position indirectly and directly supports multiple departments. From a fiscal perspective, the indirect/overhead costs generated by clinical trials support the GUMC operating costs. Without an experienced CRC II in this position, we cannot participate in the trials specified in this application, and/or future clinical trials, which would significantly hurt the revenue that these trials generate. This would be detrimental to the ongoing clinical trial operations at our site. Operationally, the CRC II coordinates with other departments such as the Clinical Research Operations Office (CROO), the Clinical Research Unit (CRU), the Research Pharmacy, the Radiology Department, Department of Medicine, Dermatology, Ophthalmology, and Gastroenterology. By interacting with other departments within the GUMC, the position indirectly supports research-related operations in departments ancillary to Neurology. On a daily basis, the CRC II will report to the Associate Director of Clinical Trials. The CRC II is part of a robust team comprised of 6 CTM/CRC II s (including the CRC II), the Associate Director, the Director of Clinical Trials, and up to 4 student hires. The CRC II is responsible for managing at least 6 trials out of the overall portfolio of approximately 55 ongoing trials within our specific department. While the CRC II's primary direct report is to the Associate Director of Clinical Trials, the CRC II will also provide project-specific deliverables to others such as, the Director of Clinical Trials, the PI for each trial, and to the sponsor contact (e.g., the study monitor appointed by the sponsor for each trial). The Associate Director and the Director of Clinical Trials rely on timely responses from the CTM/CRC II s and Director of Clinical Trials in order to effectively execute their responsibilities. On a regular basis (daily, weekly, or monthly, depending on the trial), management of the trials within the CRC II's portfolio requires ongoing communication with patients currently enrolled in each trial. The CRC II must respond to questions from patients in their portfolio in a timely manner; triage issues as they arise, facilitate communication between the PI/Sub-Is and patients for adverse events and clinical concerns, schedule future visits, send reminders for upcoming visit, ensure that the timing of the visit will work for any PIs/Sub-Is involved, reschedule when necessary, etc. Requirements and Qualifications * Bachelor's degree, at minimum * Must have at least 3 years of experience working in a clinical setting that involves direct patient interaction, in a full time, part time, or extensive volunteer experience. * Unit)directly support Clinical Trials (e.g., the GUMC Clinical Research Operations Office or Clinical Research social work, nursing, occupational health, Emergency Medical Technician, or ancillary departments that human subjects research (e.g., working in a lab or on studies for PhD candidates at an academic institution), * Must have current CITI Group 1 Biomedical, HIPAA, and IATA Training. * Must also have previous exposure to/experience handling human biological specimens; must be able to operate a centrifuge and be capable of processing and shipping laboratory samples independently * Must have phlebotomy experience * Must have previous experience accessing and reading patient medical records and must have a general working knowledge of medical care/medical operations and regulations. * Must have clinical experience measuring vital signs (Blood Pressure, Respiratory Rate, Temperature, Height, Weight), administering EKGs, performing PFTs and obtaining patient medical histories (e.g., knows how to read a medical record and is able to determine which information in the medical record needs to be capture in the patient's research record, and knows how to ask both doctors and patients to clarify ambiguous information in a medical record). * Must be highly detail oriented, organized, able to follow directions, able to work respectfully in a team, highly motivated, and committed to providing exceptional service demonstrate moral and ethical responsibility and maintain professionalism at all times * Must have excellent communication skills with respect to external communication (patients, sponsors, sponsor affiliates) and internal communication (supervisors, team members, PI, Sub-Is, ancillary department). Specifically, written communication must be clear, detailed, and free of errors. Verbal communication must be clear, relevant, and respectful at all times Work Mode Designation This position has been designated as On-Campus. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position's mode of work designation. Complete details about Georgetown University's mode of work designations for staff and AAP positions can be found on the Department of Human Resources website: *************************************************** Pay Range: The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is: $44,022.00 - $73,406.80 Compensation is determined by a number of factors including, but not limited to, the candidate's individual qualifications, experience, education, skills, and certifications, as well as the University's business needs and external factors. Current Georgetown Employees: If you currently work at Georgetown University, please exit this website and login to GMS (gms.georgetown.edu) using your Net ID and password. Then select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown. Submission Guidelines: Please note that in order to be considered an applicant for any position at Georgetown University you must submit a resume for each position of interest for which you believe you are qualified. Documents are not kept on file for future positions. Need Assistance: If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click here for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at ************ or ********************. Need some assistance with the application process? Please call ************. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website. EEO Statement: GU is an Equal Opportunity Employer. All qualified applicants are encouraged to apply, and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, matriculation, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, veteran status, or any other characteristic protected by law. Benefits: Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website.
    $44k-73.4k yearly Auto-Apply 8d ago
  • Sr. Clinical Research Associate - FSP

    Parexel 4.5company rating

    Clinical research associate job in Washington, DC

    **CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
    $82k-110k yearly est. 43d ago
  • Sr. Clinical Research Coordinator

    Childrens National 4.6company rating

    Clinical research associate job in Washington, DC

    Minimum Education B.A./B.S. degree in a science, technical, health-related field or other applicable discipline with at least 3 years of relevant experience (Required) Or Master's degree with at least 2 years of relevant experience (Required) Minimum Work Experience At least 3 years of experience with a bachelor's degree. (Required) Or At least 2 years of experience with a master's degree. (Required) Required Skills/Knowledge Knowledge of clinical research designs and needed infrastructure. Familiarity with databases, data collection tools and data analysis methods. Ability to manage multiple complex activities while maintaining close attention to detail and not losing sight of the organizational mission. Interpersonal skills that demonstrate formal and informal leadership in a diverse professional environment. Required Licenses and Certifications Internal candidates\: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification. Upon Hire (Required) External candidates\: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification within one year of hire. 1 Year (Required) Functional Accountabilities Responsible Conduct of Research Consistently demonstrates adherence to the standards for the responsible conduct of research. Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator. Stays informed of and adheres to institutional policies, and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidances (International Counsel on Harmonization) regarding human subjects' research and use of protected health information. Uses research funds and resources appropriately. Maintains confidentiality of data as required. Meets all annual job-related training and compliance requirements. Research Administration Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility. Accurately creates, completes, maintains, organizes and accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives. Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned. Attends study meetings, which could include overnight travel, as requested by principal investigator. Works well with other members of the research team, appreciates a diverse workplace and seeks and provides input when appropriate. Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center. Identifies and resolves issues and challenges with appropriate input and oversight. Reviews journals, abstracts and scientific literature to obtain information relevant to clinical research programs. Creates standard operating procedures (SOPs), and implements operational plans. Provides oversight and training to study team members for a variety of studies. Develops study documents, including consent forms and protocols. Participant Enrollment Adheres to the IRB-approved recruitment plan. Screens subjects for eligibility per the protocol and institutional policies. Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies. Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest. Engages participants/LARs in the informed consent process according to institutional policies. Study Management Conducts/participates in feasibility assessments to ensure adequate site resources and infrastructure are available for protocol participation. Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member. Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies. Authors study submissions and related documents based on functional role; this may include IRB contingency responses, ClinicalTrials.gov postings, Certificate of Confidentiality applications and scholarly presentations and publications. Registers and records participant visits in the appropriate tracking system. Anticipates study needs and subject caseload to meet organizational objectives and deadlines in a timely manner. Coordinates, prepares for and responds to routine oversight body visits and audits. Independently authors reports to oversight bodies and/or trains and oversees staff performing these tasks. Data Collection Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC\: Attributable, Legible, Contemporaneous, Original, Accurate and Complete). Ensures that queries are resolved within sponsor and institutional timelines. Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation. Ensures secure storage of study documents. Anticipate and responds to customer needs; follows up until needs are met Teamwork/Communication Demonstrate collaborative and respectful behavior Partner with all team members to achieve goals Receptive to others' ideas and opinions Performance Improvement/Problem-solving Contribute to a positive work environment Demonstrate flexibility and willingness to change Identify opportunities to improve clinical and administrative processes Make appropriate decisions, using sound judgment Cost Management/Financial Responsibility Use resources efficiently Search for less costly ways of doing things Safety Speak up when team members appear to exhibit unsafe behavior or performance Continuously validate and verify information needed for decision making or documentation Stop in the face of uncertainty and takes time to resolve the situation Demonstrate accurate, clear and timely verbal and written communication Actively promote safety for patients, families, visitors and co-workers Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance
    $59k-76k yearly est. Auto-Apply 57d ago
  • M.D./PhD Clinical Research

    Vanda Pharmaceuticals 4.5company rating

    Clinical research associate job in Washington, DC

    Vanda, a specialty pharmaceutical company based in Washington, D.C., focused on the development and commercialization of novel therapies to address high unmet medical needs and improve the lives of patients, is looking for a talented and patient focused M.D. / Ph.D to join our growing Research & Development team. Responsibilities: Responsible for developing and implementing clinical program strategies for phase I-IV studies. Participates in preparing regulatory filings (i.e. annual updates, NDAs, INDs, etc.) Manages preparation of scientific presentations and publications. Position Requirements: M.D. or PhD required Excellent written and oral communication skills Scientific publication record Must be able to perform the essential functions of the position, with or without reasonable accommodation; however, reasonable accommodations will be provided for qualified individuals with disabilities unless doing so would impose undue hardship. The total compensation package for this position will also include incentive compensation and benefits such as health insurance, unlimited paid time off, parental leave, a 401k matching program, and other benefits to its employees. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation, protected veteran status, or any other characteristic protected by law. If you reside in a state or locality with enacted pay transparency laws, you are entitled to request and receive additional details regarding compensation and benefits. For assistance, please contact us at ************ between 8:00 AM and 5:30 PM ET, Monday through Friday.
    $55k-83k yearly est. 60d+ ago
  • Clinical Associate / Staff Pathologist - #Faculty

    Johns Hopkins University 4.4company rating

    Clinical research associate job in Washington, DC

    The Pathology Department is seeking a full-time Clinical Associate/Staff Pathologist for Sibley Memorial Hospital, Washington, DC, with experience in anatomic and clinical pathology (AP/CP). The pathologist shall provide services to Johns Hopkins patients in a competent, full, and complete manner consistent with the quality of care of prevailing medical practice. The physician shall exercise independent medical judgment consistently with approved methods and practices in the Pathologist's specialty and in the best interest of the patients. Responsible for assigned cases, patient result sign-out, medical records, Peer Review Activity, and regulatory oversights. An individual may also support Administrative Services, Teaching, and Research. The pathologist also provides medical direction and other administrative and management services, including utilization review and quality assurance programs, as required by governmental and quasi-governmental agencies or JHU. MD, DO, or MD/PhD degree, with board certification or board eligibility in Anatomic and Clinical Pathology. Additional specialty training in one or two areas of pathology (e.g. Gyn, GI, GU, Cyto) is preferred. Licensure: Physician shall be qualified, professionally competent, and duly licensed to practice medicine in the State of Maryland and the District of Columbia and shall complete requirements for obtaining and maintaining licensure, including successful completion of required background checks. The physician shall obtain and maintain a current registration with the following, as applicable: Federal Drug Enforcement Administration, the Maryland State Division of Drug Control, the District of Columbia Department of Health Pharmaceutical Drug Control Division, and/or other applicable agencies of the State of Maryland and the District of Columbia. Physician represents that as of the Start Date, he/she is not subject to, or threatened with any investigation, censure, probation, suspension, or other adverse action with respect to his/her medical license in any jurisdiction. Physicians shall maintain membership with the medical staff at the assigned facilities, holding unrestricted privileges. Salary: $250,000-$350,000 Interested individuals should upload their CV, a brief statement of interest, and the names of three references Job Type: Full Time The listed salary range represents the minimum and maximum Johns Hopkins University offers for this position, based on a good faith estimate at the time of posting. Actual compensation will vary depending on factors such as location, skills, experience, market conditions, education, and internal equity. Not all candidates will qualify for the highest salary in the range. Johns Hopkins provides a comprehensive benefits package supporting health, career, and retirement. Learn more: ************************************** Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. EEO is the Law ********************************************************************************************
    $250k-350k yearly 12d ago
  • Clinical Research Coordinator

    Davita 4.6company rating

    Clinical research associate job in Washington, DC

    Posting Date 12/23/20252700 N Stanton StSte 102, El Paso, Texas, 79902-2500, United States of America At DaVita Clinical Research, we find that our best leaders are those who create an inspiring vision, have a desire to shape the future of medicine, and empower their team to achieve success. They enjoy tackling difficult problems and believe that the best way to solve them is through a collaborative environment that involves team efforts. They take ownership of results and instill accountability in those they lead. They are driven, compassionate, strong communicators, relationship builders, and find real fulfillment in challenging and impactful work. Do you love patient care? Are you a LPN or RN, but are tired of the demands of working in a healthcare setting? Have you ever explored using your clinical skills differently? Clinical Research allows a more flexible schedule for healthcare providers interested in a dynamic and fast paced environment that is on the cutting edge of medicine. Sound like you? Then you might be a great fit for a Clinical Research Coordinator role with DaVita Clinical Research (DCR) We are looking for a highly motivated, positive and innovative Clinical Research Study Coordinator (Research Coordinator) to lead in the coordination, management and conduct of nephrology clinical research trials in dialysis centers and physicians practices. DaVita Clinical Research (DCR) is a Renal Research site network conducting clinical trials across the country. DCR prides itself on a culture of growth, transparency and feedback and would want our leaders to do that same. We want a teammate who is compassionate, purposeful and motivated by meaningful work. This position will be based in our El Paso, TX site and coordinate and execute all aspects of late phase clinical trials in the El Paso and surrounding areas. Based on business needs, a flexible weekly work schedule may be available. ESSENTIAL DUTIES & RESPONSIBILITIES: Accountable for the successful execution of clinical trials through all phase of the study: enrollment, maintenance and close out. Responsible for performing research procedures according to the study protocol and working in partnership with the physician investigator to coordinate research activities. Serves as a liaison between the physicians (Principal Investigator or Sub-Investigator), study sponsors and DaVita facility teammates. Responsible to deliver or exceed project enrollment targets for clinical research studies at their site. Responsible for accurate and timely data entry into the electronic data entry systems. Responsible for timely resolution of all data queries to meet project timelines for database lock. Demonstrates compliance with good clinical practice (GCP) and applicable law, and verifies that study teams comply with GCP and applicable law. Demonstrates adherence to DCR standard operating procedures and policies and with the standards customary in the clinical research industry. Understands and promotes compliance with all applicable healthcare and research regulations. MINIMUM QUALIFICATIONS High School Diploma or equivalent is required. Bachelor's Degree is preferred. Minimum 1 year of clinical research experience managing studies from start up to close out or equivalent experience. Reliable transportation to travel between local research sites. Fluency in Spanish (spoken and written) is preferred. Commitment to and role model of DaVita's values with ability to demonstrate those positively and proactively to patients, teammates, management, physicians, and/or vendors (Village Service Partners) in everyday performance and interactions. Ability to manage multiple projects, meet deadlines, and adjust priorities appropriately in an evolving work environment with shifting time frames; self-starter with high degree of initiative, urgency, and follow through. Experience in managing confidential information and/or issues using discretion and Judgment Certified Clinical Research Coordinator (SOCRA or ACRP) - preferred DaVita Clinical Research (DCR), a wholly owned subsidiary of DaVita Inc., is the research arm of DaVita. DCR innovates through retrospective outcomes research aimed at improving care and quality of life for people with kidney disease. DCR assists pharmaceutical and medical device companies in the design, recruitment and completion of clinical trials using its renal research site network. For 30 years we have helped 500+ clients with their development projects. DCR is based in Minneapolis, MN and operates in locations across the US. What We'll Provide: More than just pay, our DaVita Rewards package connects teammates to what matters most. Teammates are eligible to begin receiving benefits on the first day of the month following or coinciding with one month of continuous employment. Below are some of our benefit offerings. Flexible weekly work schedule: This will vary and is based on current business needs December Industry wellness break (Week between Christmas and New Year's Day) Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out Support for you and your family: Family resources, EAP counseling sessions, access Headspace , backup child and elder care, maternity/paternity leave and more Professional development programs: DaVita offers a variety of programs to help strong performers grow within their career and also offers on-demand virtual leadership and development courses through DaVita's online training platform StarLearning. Here is what you can expect when you join our Village: • A "community first, company second" culture based on Core Values that really matter. • Clinical outcomes consistently ranked above the national average. • Award-winning education and training across multiple career paths to help you reach your potential. • Performance-based rewards based on stellar individual and team contributions. • A comprehensive benefits package designed to enhance your health, your financial well-being and your future. • Dedication, above all, to caring for patients suffering from chronic kidney failure across the nation. Join us as we pursue our vision "To Build the Greatest Healthcare Community the World has Ever Seen." Why wait? Explore a career with DaVita today. Go to ************************* to learn more or apply #LI-JD2 At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and comply with state and federal affirmative action requirements. Individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic. This position will be open for a minimum of three days. For location-specific minimum wage details, see the following link: DaVita.jobs/WageRates Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at *********************************** Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.
    $48k-61k yearly est. Auto-Apply 36d ago
  • Sr. Clinical Research Coordinator

    Cnhs 3.9company rating

    Clinical research associate job in Washington, DC

    Sr. Clinical Research Coordinator - (2600002N) Description The Senior Clinical Research Coordinator independently leads day-to-day operations of clinical research studies conducted by a principal investigator with limited supervision. In addition, the individual performs a variety of complex duties involved in the collection, compilation, documentation and analysis of clinical research data. The Senior Clinical Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. This individual may support multiple investigators with clinical and translational research projects and direct the work of a Clinical Research Assistant and Clinical Research Coordinator as assigned. Qualifications Minimum EducationBachelor's Degree B. A. /B. S. degree in a science, technical, health-related field or other applicable discipline with at least 3 years of relevant experience (Required) OrMaster's Degree Master's degree with at least 2 years of relevant experience (Required) Minimum Work Experience3 years At least 3 years of experience with a bachelor's degree. (Required) Or2 years At least 2 years of experience with a master's degree. (Required) Required Skills/KnowledgeKnowledge of clinical research designs and needed infrastructure. Familiarity with databases, data collection tools and data analysis methods. Ability to manage multiple complex activities while maintaining close attention to detail and not losing sight of the organizational mission. Interpersonal skills that demonstrate formal and informal leadership in a diverse professional environment. Required Licenses and Certifications Internal candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification. Upon Hire (Required) External candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification within one year of hire. 1 Year (Required) Functional AccountabilitiesResponsible Conduct of ResearchConsistently demonstrates adherence to the standards for the responsible conduct of research. Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator. Stays informed of and adheres to institutional policies, and federal regulations (e. g. Titles 21 and 45 of the Code of Federal Regulations) and guidances (International Counsel on Harmonization) regarding human subjects' research and use of protected health information. Uses research funds and resources appropriately. Maintains confidentiality of data as required. Meets all annual job-related training and compliance requirements. Research AdministrationMaintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility. Accurately creates, completes, maintains, organizes and accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives. Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned. Attends study meetings, which could include overnight travel, as requested by principal investigator. Works well with other members of the research team, appreciates a diverse workplace and seeks and provides input when appropriate. Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center. Identifies and resolves issues and challenges with appropriate input and oversight. Reviews journals, abstracts and scientific literature to obtain information relevant to clinical research programs. Creates standard operating procedures (SOPs), and implements operational plans. Provides oversight and training to study team members for a variety of studies. Develops study documents, including consent forms and protocols. Participant EnrollmentAdheres to the IRB-approved recruitment plan. Screens subjects for eligibility per the protocol and institutional policies. Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies. Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest. Engages participants/LARs in the informed consent process according to institutional policies. Study ManagementConducts/participates in feasibility assessments to ensure adequate site resources and infrastructure are available for protocol participation. Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member. Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies. Authors study submissions and related documents based on functional role; this may include IRB contingency responses, ClinicalTrials. gov postings, Certificate of Confidentiality applications and scholarly presentations and publications. Registers and records participant visits in the appropriate tracking system. Anticipates study needs and subject caseload to meet organizational objectives and deadlines in a timely manner. Coordinates, prepares for and responds to routine oversight body visits and audits. Independently authors reports to oversight bodies and/or trains and oversees staff performing these tasks. Data CollectionEnsures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete). Ensures that queries are resolved within sponsor and institutional timelines. Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation. Ensures secure storage of study documents. Organizational AccountabilitiesOrganizational Accountabilities (Staff) Organizational Commitment/Identification Anticipate and responds to customer needs; follows up until needs are met Teamwork/Communication Demonstrate collaborative and respectful behavior Partner with all team members to achieve goals Receptive to others' ideas and opinions Performance Improvement/Problem-solving Contribute to a positive work environment Demonstrate flexibility and willingness to change Identify opportunities to improve clinical and administrative processes Make appropriate decisions, using sound judgment Cost Management/Financial Responsibility Use resources efficiently Search for less costly ways of doing things Safety Speak up when team members appear to exhibit unsafe behavior or performance Continuously validate and verify information needed for decision making or documentation Stop in the face of uncertainty and takes time to resolve the situation Demonstrate accurate, clear and timely verbal and written communication Actively promote safety for patients, families, visitors and co-workers Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance Primary Location: District of Columbia-WashingtonWork Locations: CN Hospital (Main Campus) 111 Michigan Avenue NW Washington 20010Job: ResearchOrganization: Sheikh Zayed Ctr Ped Surg InnoPosition Status: R (Regular) - FT - Full-TimeShift: DayWork Schedule: M-F 9a-5pJob Posting: Jan 19, 2026, 9:00:00 PMFull-Time Salary Range: 54516. 8 - 90854. 4
    $56k-66k yearly est. Auto-Apply 6h ago
  • Clinical Research Coordinator - Medical Center

    Georgetown University 4.6company rating

    Clinical research associate job in Washington, DC

    Georgetown University comprises two unique campuses in the nation's capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world. Requirements Job Overview The Clinical Research Coordinator (CRC) will be responsible for managing a portfolio of clinical trials overseen by the Clinical Research Organization (CRO) at Georgetown University Medical Center (GUMC). Working under the direct supervision of the Director of the CRO, the CRC will coordinate and oversee complex clinical trials across multiple studies and therapeutic areas. The CRO supports research efforts for various clinical departments within GUMC, and the CRC plays a critical role in ensuring that all trials are conducted in strict accordance with study protocols, regulatory requirements, institutional policies, and Good Clinical Practice (GCP) guidelines. This individual will also provide direct support to research participants and collaborate closely with internal and external stakeholders to maintain high standards of research integrity and compliance. Duties include but are not limited to: * Coordinate and manage clinical research studies, ensuring compliance with regulatory, institutional, and sponsor requirements * Recruit, consent, and monitor study participants; conduct study visits and collect clinical data * Maintain accurate study documentation, including regulatory submissions, data entry, and reporting of adverse events * Serve as a liaison between investigators, sponsors, IRB, and other research and clinical staff to support study integrity and progress Work Interactions This position reports directly to the Director of the Clinical Research Organization (CRO), who in turn reports to the Vice President for Biomedical Graduate Education and Research. The Clinical Research Coordinator will have direct interaction with research participants, and their families. They will work as part of the multidisciplinary Georgetown-MedStar research team and will serve as the primary point of contact for study sponsors, contract research organizations (CROs), and institutional review boards (IRBs). Requirements and Qualifications * Minimum Bachelor's degree in a scientific or related field * 1-3 years of clinical research experience preferably at an academic medical center * Excellent written and verbal communication skills * Detail oriented with strong documentation skills * Familiarity with human subjects research regulations (IRB, FDA, HIPAA) * Strong organizational, critical thinking, and problem-solving skills * Proficient in Microsoft Office Suite and research database systems * Experience with OnCore (Clinical Trials Management System) * Experience with electronic data capture systems (e.g., REDCap, Medidata, etc.) * Certified clinical research certification (SoCRA or ACRP) preferred Work Mode Designation This position has been designated as On-Campus. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position's mode of work designation. Complete details about Georgetown University's mode of work designations for staff positions can be found on the Department of Human Resources website: *************************************************** Pay Range: The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is: $20.16 - $31.30 Compensation is determined by a number of factors including, but not limited to, the candidate's individual qualifications, experience, education, skills, and certifications, as well as the University's business needs and external factors. Current Georgetown Employees: If you currently work at Georgetown University, please exit this website and login to GMS (gms.georgetown.edu) using your Net ID and password. Then select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown. Submission Guidelines: Please note that in order to be considered an applicant for any position at Georgetown University you must submit a resume for each position of interest for which you believe you are qualified. Documents are not kept on file for future positions. Need Assistance: If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click here for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at ************ or ********************. Need some assistance with the application process? Please call ************. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website. EEO Statement: GU is an Equal Opportunity Employer. All qualified applicants are encouraged to apply, and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, matriculation, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, veteran status, or any other characteristic protected by law. Benefits: Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website.
    $20.2-31.3 hourly Auto-Apply 60d+ ago

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