Clinical research associate jobs in Washington, DC - 189 jobs

Loudoun County Government has been named one of Forbes' 2025 Best Large Employers! We're proud to be recognized nationally for our commitment to employee satisfaction and excellence in public service. At Loudoun County, we bring together talented professionals from all backgrounds to make a meaningful impact in a dynamic, growing community - that's The Loudoun Difference . Welcome and thank you for your interest in employment with Loudoun County Government! ALL SECTIONS OF THE APPLICATION MUST BE COMPLETED IN ITS ENTIRETY. THE RESUME IS CONSIDERED SUPPLEMENTAL INFORMATION ONLY. APPLICATIONS THAT ARE INCOMPLETE OR INDICATE 'SEE RESUME' WILL NOT BE TAKEN INTO CONSIDERATION. Introduction Loudoun County Animal Services is a progressive public animal services agency that provides veterinary services, humane education, animal sheltering, and humane law enforcement for more than 440,000 residents in our community in Northern Virginia (outside of the Washington, DC area) and receives around 2,500 animals annually. Our staff works in a bright, modern facility (opened in 2021) that was the first public animal shelter in the United States to meet 100% of the Association of Shelter Veterinarians' Animal Shelter Guidelines. We prioritize a meaningful, collaborative, and positive work culture and are committed to providing high quality veterinary care to those animals in our care. Compensation is competitive, the comprehensive benefits package is excellent (including continuing education, pension, healthcare and retirement), and every day offers the opportunity to engage in meaningful public service. Job Summary Loudoun County Animal Services (LCAS) is hiring for the new role of Veterinary Clinic Coordinator. This position will handle all aspects of administration and coordination of our onsite veterinary clinic and offsite public outreach veterinary services. LCAS has a medical team comprised of 2 full time veterinarians, four veterinary technicians and we are expanding our outreach programs which already provide low-cost vaccines, free microchips and low cost spay/neuter for nearly 2,600 publicly owned pets each year in addition to our shelter animals. Licensed veterinary technician is strongly preferred. Core components of this position include: Supporting the daily operations of the veterinary team, including staff scheduling and work assignments, maintaining sufficient inventory of medicines and other clinic supplies, scheduling maintenance of clinical equipment, and tracking of continuing education records required for veterinarians and licensed veterinary technicians. Overseeing all aspects of operations for public clinics which provide accessible low-cost vaccines to up to 150 clients in a morning, or up to 20 spay/neuter surgeries in a day. Coordinating with relevant staff to schedule medical care and procedures for animals in department custody, in the shelter and foster homes. Overseeing all aspects of public clinic services, including scheduling, staffing, stocking supplies, as well as preparation of waivers, animal records, and data entry. Managing veterinary team budget, processing purchase orders, receipts, bills, invoices and related spreadsheets. The successful candidate will: Have knowledge of veterinary medicine, the Veterinary Practice Act as well as state and local laws governing veterinary clinics and animal shelters. Be skilled in the care of animals, including the ability to perform veterinary technician tasks and procedures, such as giving injections for the purpose of euthanasia. Have excellent written and verbal communication skills, be proficient in computer programs and handle large volumes of data entry accurately. Be team-oriented and enjoy working with people as much as with animals and have the ability to self-start and make leadership decisions. Interested applicants are encouraged to include a cover letter with their application. This position works weekends with a typical schedule of Tuesday through Saturday and is eligible for a $2,000 relocation incentive for qualified candidates. Hiring salary commensurate with experience. Minimum Qualifications Position requires any combination of education and experience equivalent to an Associate's degree and two (2) years of related work experience in a veterinary clinic or animal shelter. Preferred Qualifications: Virginia Licensed Veterinary Technician Spanish bilingual - proficiency incentive available Job Contingencies and Special Requirements Must possess a valid driver's license and good driving record. Successful candidate will undergo criminal, credit and DMV background checks, as well as pre-employment physical exam with drug screening. Must be able to be listed on facility DEA license to oversee controlled substances. Candidate will be required to obtain certifications in Fear Free, CPR, First Aid, and FEMA ICS 100, 200, 700, and 800, as well as certification to perform humane euthanasia within 6 months of hire. Animal Services is a physically demanding occupation, with the potential for exposure to infectious diseases, viruses, noxious fumes and chemicals, as well as risk of injury. A rabies pre-exposure vaccination series will commence immediately upon hire unless proof of prior vaccination is provided. Candidate should not have allergies to, or fear of, common companion animal species, including cats, dogs, reptiles, guinea pigs and rabbits. Knowledge of and experience with handling dogs, cats, and other companion animals required.

With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to join us! As a global leader we're looking for a Senior **Lead Clinical Research Associate (CRA)** to drive success as part of our Non-interventional Study team. Join Oracle as a Lead CRA and make a real impact by guiding teams, ensuring top-quality clinical research, and driving groundbreaking projects on a global scale! **What you will do** **As a Senior Lead Clinical Research Associate at Oracle, you will:** + **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors. + **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters. + **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents. + **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans. + **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management. + **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports. + **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement. + **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required. **Required Experience** + **Education** : Bachelor's degree in Life Sciences, Medical Science, Pharmacy, Public Health, or equivalent, with a minimum of three years' hands-on clinical research experience. + **Clinical research expertise** : At least 3 years of experience as a CRA, including site initiation, Trial Master File (TMF) management, and site monitoring for both clinical and non-interventional studies. + **Communication skills** : Outstanding spoken and written proficiency in English (C1 level minimum).Additional languages are considered a strong asset. + **Technical proficiency** : Comfort with MS Office, EDC, CTMS exprience and willingness to learn and handle various technical systems and tools. + **Personal qualities** : Exceptional organizational and problem-solving skills, strong cross-culturalteamwork, initiative in process optimization, and the ability to manage competing priorities in a fast-paced environment. + **Financial management:** Experience reviewing site contracts, budget and invoices. + **Attention to detail** : Ability to work independently with careful, precise, and thorough execution of complex tasks. **Responsibilities** **What you will do** **As a Senior Lead Clinical Research Associate at Oracle, you will:** + **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors. + **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters. + **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents. + **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans. + **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management. + **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports. + **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement. + **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required. Disclaimer: **Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.** **Range and benefit information provided in this posting are specific to the stated locations only** US: Hiring Range in USD from: $70,600 to $141,200 per annum. May be eligible for bonus and equity. Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity. Oracle US offers a comprehensive benefits package which includes the following: 1. Medical, dental, and vision insurance, including expert medical opinion 2. Short term disability and long term disability 3. Life insurance and AD&D 4. Supplemental life insurance (Employee/Spouse/Child) 5. Health care and dependent care Flexible Spending Accounts 6. Pre-tax commuter and parking benefits 7. 401(k) Savings and Investment Plan with company match 8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation. 9. 11 paid holidays 10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours. 11. Paid parental leave 12. Adoption assistance 13. Employee Stock Purchase Plan 14. Financial planning and group legal 15. Voluntary benefits including auto, homeowner and pet insurance The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. Career Level - IC3 **About Us** As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_************* or by calling *************** in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.

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

**Job Purpose:** 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 sponsor 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. **Key Accountabilities:** **Oversight of 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 sponsor 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 SCP 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 SCP 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 sponsor's credibility, scientific leadership and in order to facilitate sponsor's 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 **Collaboration** + Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) + May act as a Mentor for Clinical Research Associates **Skills:** + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization + Preferred therapeutic experience in Oncology + Global clinical trial experience preferred + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Must be fluent in English and in the native language(s) of the country they will work in + Travel (60-80%) within area is required + Valid driver's license and passport required **Knowledge and Experience:** + Demonstrated knowledge of clinical research and development processes and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.) + Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) + Demonstrated ability to support sponsor regulatory interactions/inspections + Demonstrated knowledge of the processes around protocol design and feasibility assessment + Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery + Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial + Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation + Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required \#LI-CF1 \#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.

The opportunity: As the In-house CRA you will support and coordinate the logistical aspects of clinical trial management, site management, data review and cleaning according to FDA regulations, Good Clinical Practice (GCP) and relevant SOPs and acts as a pivotal point of contact for the clinical trial team. Under general supervision, you will assist with the coordination of activities associated with the start-up, conduct, and close-out of clinical trials and other duties as assigned. Although prior CRA experience is not essential, a working knowledge of the clinical trial process and associated regulations, responsibilities, and roles are required. What you'll be doing: Assists in the development and editing of study-related materials (e.g. consent forms, study binders, site study aids) Assists with preparation of training workshops, Investigator/Advisory Board meeting materials Assists with all phases of clinical trial activities (e.g. start-up, conduct, and close-out) Develops study tracking tools (e.g. site lists, enrollment tracking, vendor spreadsheets) Maintains tracking spreadsheets/databases and provides routine reports/dashboards to study team members Requests PO independently, may review invoices with oversight from Clinical Project Manager (CPM) Tracks essential documents and maintains/reviews the eTMF under the guidance of CPM. Assists with management of investigational product and study supplies by ensuring the accuracy of shipments of study-related materials and collection of regulatory documents required for IP release May attend co-monitoring visits or other site visits based on experience and training provided by and under guidance of CPM or designee Assists the CPM with the review of clinical database and management of flow of data, including but not limited to facilitating resolution of queries Assists with collection, review and filing of regulatory and other essential documents from clinical personnel (e.g. site trip reports) and sites (e.g. FDA 1572 reports) Assists with filing and management of the Electronic Trial Master File (eTMF) Distributes meeting's agenda, prepare and distributes final meeting minutes including documentation of action items May assume a specialized administrative role (e.g. SOP Administrator) Travel up to 5% of the time is required It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives. What we're looking for: We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications: A Bachelor's degree (BA or BS) with an emphasis on scientific discipline or related healthcare field preferred, however, the combination of experience working in clinical research field and training will be taken under consideration. 1-2 years applicable experience in a pharmaceutical, biotechnology, CRO and /or healthcare setting required Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations, GCP/ICH R2 Demonstrate core understanding of medical terminology or clinical trial activities Must have working knowledge and understanding of clinical protocols, and all other associated study related documents Advanced knowledge of Word, Excel and Power Point and Outlook Knowledge of the principles and practices of computer applications in database management Must have a high degree of customer focus toward internal and external stakeholders Must display strong analytical and problem-solving skills Strong interpersonal and relationship management with the cross-functional team and external vendors skills Clear and concise verbal and written communication skills Attention to detail and organizational skills required Ability to establish priorities, excellent sense of urgency to manage multiple tasks and deadlines Why should you apply? By joining REGENXBIO, you will have the opportunity to be a part of a growing company, with an incredible team, who is passionate about developing novel AAV gene therapies for patients in need. We offer a comprehensive and competitive benefit & compensation package which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more! In addition, professional development is important to us. By joining our team, you'll have the opportunity to be exposed to challenging projects and have access to development resources to help you grow personally and professionally. Qualifications Preferred Bachelor of Science (B.S.) or better.

Job Description Postdoctoral Research Scientist & Clinical Psychologist - PTSD & Addiction Research Location: Rockville, MD | Full-Time Join a dynamic team advancing evidence-based treatment for addiction and PTSD. Maryland Treatment Centers (MTC) is seeking a full-time Research Scientist and Clinical Psychologist to support innovative addiction research within our Rockville treatment center. This role offers the chance to develop a research-oriented career in substance use disorder (SUD) and trauma treatment while working alongside a multidisciplinary clinical team. What You'll Do: · Coordinate a clinical trial for the treatment of PTSD taking place within a residential addiction treatment setting. · Provide direct clinical services (Written Exposure Therapy for PTSD) as a study therapist on the project. · Supervise research staff and assist with data collection and analysis. · Collaborate with senior researchers on publications, grant development, and new studies. · Mentor trainees and participate in extern supervision and teaching. Why Join Us: · Be part of a robust research division housed within a community treatment program · Work in a supportive, collaborative, and mission-driven environment. · Receive mentorship, professional development, and travel support for research dissemination. · Grow into leadership roles in clinical research or program development. What We're Looking For: · PhD or PsyD in Clinical Psychology (or related field). · Licensed or license-eligible in Maryland (supervision possible). · Interest or experience in addiction and trauma research preferred. · Masters-level clinicians with research curiosity encouraged to apply (e.g., LCPC, LCSW).

Job DescriptionDescriptionBiomedical/Clinical Research Information Specialist WHO WE ARE: STAHL Companies provides the Program Management for its Channel of Commercial Technology companies in Government that consist of Small Businesses and New Technology start-ups. STAHL advocates for policies that can improve government services and maintain our government's competitive advantage, by bringing more technology into government programs. STAHL Companies advocates on behalf of our nation's innovative, new technology and small businesses looking to work with the U.S. government. We do this by aligning the voice of our small business members with advocacy for change in federal policy that will make the government market more accessible to small businesses and the commercial technology ecosystem. The Channel's founding Technical Board Members include former government leaders and IT executives passionate about bringing best-of-breed technology to the government. We are seeking a skilled and experienced Biomedical/Clinical Research Information Specialist to join our team! Responsibilities:Content expertise and editorial efforts are required in the following subject areas: · Drugs, agents, reagents and carcinogens; · Clinical procedures, treatment, prevention, imaging, and related topics; · Diseases, findings, and related clinical and molecular abnormalities; · Genomics, biomarkers, public health, demography. Qualifications:· A minimum of five (5) years of progressively responsible experience in the individual's field of study and specialization. · Augments or directs teams providing high level content analysis, design, integration, documentation and implementation advise on complex issues requiring an advanced specialist degree-level knowledge in the individual's field of study. · Designs and prepares technical reports and documentation to support findings and study results. · Prepares executive-level briefings, including charts and graphs to present findings to client managers. · For editors working on clinical terminology, degrees in nursing, pharmacology/pharmacy, public health, medicine, biology, molecular biology, or related field is required. · Experience with terminology creation and modeling, data standards, and best terminology practice is desirable. *Position is contingent upon award. Work Location: NCI Location, USA To know more about the company, visit Stahl Companies (stahlusa.us) Key ResponsibilitiesContent expertise and editorial efforts are required in the following subject areas: · Drugs, agents, reagents and carcinogens; · Clinical procedures, treatment, prevention, imaging, and related topics; · Diseases, findings, and related clinical and molecular abnormalities; · Genomics, biomarkers, public health, demography.

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. 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 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

Job Description This role will be key in developing internal Clinical Operations systems and procedures to improve all aspects of Clinical Study related business processes and will work very closely with the Associate Director of Clinical Operations along with the US Site Head. Location: Gaithersburg, Maryland Responsibilities: Participates in the planning, implementation and management of pre-IND through Phase I-II clinical trials, in collaboration with Contract Research Organization (CRO) partners, if applicable. Manage day to day activities of all aspects of clinical studies including study plans, timelines, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams. Contributes to development of RFPs and participates in selection of CROs/vendors. Manages CRO and vendor activities to ensure adherence to deliverables and timelines. Provides updates on project status and deliverables to Clinical Project Management leads (deliverables may include project status reports, vendor reports, trackers, meeting minutes/action items). Contributes to development of study budget(s). Maintains primary responsibility for the content of and execution on all study-related operational plans, such as study operations manuals, vendor manuals, safety plans, project management plans, communication plans, and quality plans, whether developed internally or externally. Oversees investigator recruitment/selection and the conduct of trials at investigative sites. Participate as necessary in monitoring visits (co-monitoring), reviews monitoring visit reports and ensures CRO quality within trials, if applicable. Plans, executes, and leads Investigators Meetings, if applicable. Contributes to development of internal Clinical Operations systems to improve business processes. Develops relationships with Key Opinion Leaders as applicable for key I-Mab development programs. Prepare and present study or project specific updates. Represent Project Management & Clinical Operations in partnered development programs. Mentors junior level Clinical Research Associates. Qualifications: Life sciences or medical background is required. 6+ years of industry experience (biotech/pharma) with at least 2-5 (will determine level) years of project management experience Experience in Phase 1 Oncology trials. Strong understanding of ICH, GCP and relevant regulatory requirements The ability to work with cross-functional teams in a matrix environment is a must Strong organizational and time management skills; detailed oriented; excellent interpersonal and communication skills Proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project.

Job Description Our client is seeking a Senior Clinical Project Manager / Associate Director, Clinical Operations to lead the clinical operations for their early-phase celiac disease trial. This role offers the opportunity to manage a CRO team, oversee study timelines and budgets, and contribute to protocol design and trial strategy. The position is remote-friendly, reports to the CMO, and provides a clear path to grow into a Director of Clinical Operations as the company's pipeline expands post-merger. Ideal candidates have experience leading teams at CROs, managing early-phase studies, and driving complex clinical programs to deliver results. Main purpose of the job: To assist with the clinical activities to support our clients' portfolio of research and development projects. All activities carried out with regard to time, cost, and quality, and in accordance with SOPs, ICH/ GCP guidelines, and local regulations. Key responsibilities include: Management and oversight of all aspects of allocated studies in accordance with internal SOPs, ICH GCP, relevant guidelines, and all applicable laws and regulations. Study team coordination and leadership. Oversight of all aspects of the study to ensure agreed study deliverables are met to the appropriate quality. Responsibility for the preparation of study documentation and coordination of document review, e.g., protocols, IBs, DSURs, ICFs, CSRs. Selection and oversight of assigned CROs, vendors, or contract monitors (CRAs), as appropriate. Selection of suitable clinical sites in collaboration with other members of the Barinthus study team or CROs, as appropriate. Periodic co- ‐monitoring with contract CRAs or CROs as necessary for each study, to ensure high-quality monitoring and site management. Set up and management of clinical contracts (including Clinical Site Agreements). Coordination of IRB/IEC and other required study submissions, and provision of essential documents to the Regulatory Head (or CRO if delegated) for regulatory submissions. Preparation of study budgets, forecasting, and accruals. Thorough documentation of study team activities, decisions, actions, and risk assessments. Active management of clinical trials supply requirements in collaboration with 3rd party storage & distribution specialists. Oversight of Sponsor Oversight File and/or TMF creation and maintenance by Clinical Trial Administrator, to ensure ‘inspection- ‐ readiness' of documentation at all times. Active acquisition and furthering of therapeutic area knowledge appropriate to assigned studies. Assist with departmental development work, e.g., SOP review/writing and process improvements initiatives. Develop and maintain relations with sites and KOLs. Other Responsibilities of the Role: Personal abilities and traits: Demonstrates personal drive and goal orientation. Self-motivated, taking personal pride in delivering on personal and corporate objectives. Enthusiastic and flexible to change. Demonstrates strong organisational and prioritisation skills to manage a diverse workload. Able to interact with individuals at all levels of the organisation. A highly effective communicator, both orally and in writing, with an eye for detail/ accuracy. Reliable and trustworthy, able to work with minimal supervision. Qualifications and/or experience required to perform the role Essential knowledge, experience, and skills: BSc or equivalent. Clinical study management experience within a pharmaceutical, biotech, or CRO company. Experience in oversight of external vendors (CROs, central labs, imaging vendors, etc). Excellent written and verbal communication and presentation skills. Excellent organisational and interpersonal skills. Ability to manage multiple priorities within one or across different projects. Excellent working knowledge of GCP and current clinical trial legislation. Thorough knowledge of the clinical development process, ideally from first-in-human through to regulatory filing for marketing. Ability to travel in the USA and abroad periodically if needed. Ability to work in a dynamic small team environment. Desired skills: Experience in early phase (I- ‐II) studies. Working with GMO experience. CRA/monitoring experience. Experience of EDC and eTMF; comfortable with electronic systems, e.g., CTMS. Autoimmune Diseases and Immunology experience.

NJ Eye LLC is a private equity backed, independent, integrated eye care organization with its corporate headquarters in Union, New Jersey. The company has over 250 eye care professionals and business support roles across a growing network of over 17 eye care clinic locations, spanning New Jersey, with plans to affiliate with other eye care practices in New Jersey, New York, Connecticut, Pennsylvania, Delaware, Maryland, and nationwide. Role and Responsibilities: Leads recruitment efforts and screens potential patients for eligibility for studies Ability to achieve enrollment targets on assigned studies Obtains informed consent from patients and conducts study visits for clinical trials Creates Case Report Forms Completes assessments on study subjects as per protocol Documents study assessments Enters study data into EDC systems Collects, processes, stores and ships lab specimens; documents lab procedures, lab results and follows up with patients and medical staff as necessary Coordinates, monitors visits with CRAs for each trial to ensure accurate documentation; makes corrections to data as necessary Assists during sponsor and FDA audits Responsible for submissions and reports to the IRB; maintains documentation of IRB communications and decisions Documents adverse events and notifies PI, sponsor and IRB Assumes test article accountability Possesses a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility Maintains compliance with Good Clinical Practice; Clinical Safety Data Management, 21 CFR, and has IATA certification Travels to investigator meetings Participates in weekly meetings with the research team, provides study metrics Responds to requests in a timely manner, gives/receives correct information, encourages dialogue and follow-through, secures accurate signatures, maintains files in an organized and up-to-date manner Other tasks as required Qualifications: Education: Bachelor's degree preferably in Science or related field. Equivalent relevant experience and/or training in lieu of education is acceptable. Experience: 2+ years' relevant experience (e.g. research, clinical, interaction with study population, program coordination) Knowledge/Skills/Experience: Excellent Excel, Word, PowerPoint and reporting skills Excellent interpersonal skills to deal effectively with patients, physicians, clinicians and administrators Excellent organizational skills and self-management skills to independently manage work flow Ability to prioritize Meticulous attention to detail Knowledge of medical terminology Knowledge of good clinical practice, FDA, OHRP, HIPAA policies Ability to use EMR data as a subject recruitment tool Experience using Microsoft Office Suite, and clinical research systems (CTMS, Regulatory) Certification through either ACRP or SoCRA highly preferred At PRISM Vision Group, we believe great work deserves great rewards. Here's what you can expect when you join our team: Salary Range: $49,000.00 to $70,000 USD Competitive Compensation - Base salary, performance bonuses, and regular reviews. Health & Wellness - Comprehensive medical, dental, and vision insurance; and wellness program. Retirement Planning - 401(k) with company match. Generous Time Off - Paid vacation, sick leave, and company holidays. Learning & Development -career growth programs. Other Perks - Commuter benefits, Voluntary Accident and Critical Illness plans, FSA/HSA and Dependent Care FSA. employee discounts, and more. NJ Eye LLC is an Equal Opportunity / Affirmative Action employer. Candidates are selected solely on the basis of legally permissible job-related criteria without regard to race, color, religion, sex, national origin, disability, marital status, or sexual orientation, in accordance with federal and state law.

Department: College of Science Classification: GMU Worker Job Category: Part-Time / Hourly Wage Job Type: Part-Time Work Schedule: 20 hours per week Workplace Type: On Site Required Hourly Rate: $21 to $30 per hour, depending on experience Criminal Background Check: Yes About the Department: The George Mason University School of Systems Biology (SSB), within the College of Science (COS), invites applications for a part-time Research Administrator in the Kashanchi Research lab. George Mason University has a strong institutional commitment to the achievement of excellence and diversity among its faculty and staff, and strongly encourages applicants who will enrich Mason's academic and culturally inclusive environment. George Mason University College of Science (Mason Science) is committed to advancing inclusive excellence and fostering an environment free from discrimination, harassment, and retaliation throughout our STEM community. At Mason Science, our values include cultivating an organizational culture that promotes belonging, respect, and civility. We believe that varied opinions, cultures, and perspectives are what provides vibrancy, innovation, and growth to an academic community. By prioritizing cultural responsiveness in academics, teaching, research, and global engagement, we strive to attract faculty and staff who exemplify the Mason Science mission and vision. About the Position: The Research Administrator will be focused on gathering and collecting research data, data analysis, and a wide variety of written materials including manuscript writing, grant proposals, and research summaries. Scientific writings will also include assisting with the preparation and submission of research, service, training, and other proposals to support the activities of George Mason University. This will involve coordination of large amounts of data with individuals in research labs, and the maintenance of records and generation of reports and scientific writing needs (e.g., journal articles, white papers, etc.). The part-time position starts at 20 hours per week. The hourly rate is $21 to $30 per hour, depending on experience. Responsibilities: The position will be focused on gathering and collecting research data, data analysis, and a wide variety of written materials including manuscript writing, grant proposals, and research summaries. Scientific writings will also include assisting with the preparation and submission of research, service, training, and other proposals to support the activities of George Mason University. This will involve coordination of large amounts of data with individuals in research labs, and the maintenance of records and generation of reports and scientific writing needs (e.g., journal articles, white papers, etc.). Required Qualifications: Bachelor's degree in Biology from an accredited college/university is required; At least two years of experience in scientific manuscripts, or other technical reports; Experience using applications such as Microsoft Word, Excel, and PowerPoint; and Must have exceptional communication and technical writing skills, including technical editing, to facilitate preparation and editing of grant proposals. Preferred Qualifications: Master's degree in Biology. Instructions to Applicants: For full consideration, applicants must apply for the Research Administrator at ********************** complete and submit the online application to include three professional references with contact information; and provide a cover letter and resume for review. Posting Open Date: December 10, 2025 For Full Consideration, Apply by: January 5, 2026 Open Until Filled?: Yes

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 ********************************************************************************************

The role: The Clinical Trial Manager is responsible for the delivery of all clinical aspects of the study. The CTM oversees the clinical portion of the budget, develops monitoring plans & tools, trains CRAs, drives enrolment and study start -up activities, reviews trip reports, implements corrective and preventative action plans, liaises with the Sponsor, vendors & cross -functional teams, identifies & mitigates risks that may impact clinical delivery, and provides reporting & metrics on all clinical activities. The CTM will also participate in Sponsor, Investigator and bid defense meetings. You will need: • 4 year degree or equivalent combination of education & experience • Demonstrated ability to drive the clinical deliverables of a study • Subject matter expertise in the designated therapeutic area • Prior monitoring experience is preferred • Ability to travel up to 20% • Fluent in local language - both written & verbal

) Contract Duration: Open-ended contract (expected to be 8 months) Job Type: 30 hours per week (Monday-Friday) - during normal business hours We are seeking an onsite Clinical Research Coordinator (CRC) with experience in clinical research to support an ongoing Cardiology clinical trial. The ideal candidate will be able to work independently and act as one of the main CRCs for this study. Key Responsibilities: Medical Record Review: Conduct thorough reviews of patient medical records. Participant Screening: Perform phone screenings or prescreen participants for eligibility. Informed Consent: Obtain informed consent from trial participants. Data Management: Collect study data and enter it into electronic data capture (EDC) systems. Query Resolution: Address and resolve data queries promptly. Participant Follow-Up: Conduct follow-up with study subjects to ensure retention. Scheduling: Arrange in-patient visits and follow-up appointments, and send reminders. Qualifications: Clinical Research Experience: Prior experience in a clinical research coordinator role required. Systems Experience: Proficiency with electronic medical records (EMR) and electronic data capture (EDC) systems Strong Communication Skills: Ability to interact professionally with study participants and team members. Attention to Detail: High level of accuracy in documentation and protocol compliance. Job Type & Location This is a Contract position based out of Falls Church, VA. Pay and Benefits The pay range for this position is $25.00 - $35.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Falls Church,VA. Application Deadline This position is anticipated to close on Jan 28, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

Clinical Research Coordinator I will perform delegated duties such as protocol required visit procedures, administering questionnaires and subject material, administering, and dispensing medication, adhering to regulatory guidelines, and participating in subject recruitment efforts, under the oversight of the study Principal Investigator. The Clinical Research Coordinator needs to engage with the Principal Investigators, pharmaceutical companies (Sponsors) and contract research organizations (monitors) as well as the research subjects. Responsibilities include: Read and understand assigned research protocols. Prescreen patients. Train site staff on study purpose, record attendance. Evaluate resources needed and on-hand to appropriately deploy the study. Drive enrollment to meet contractual targets: Using the EMR, screen for eligible patients for discussion and qualification by the Principal Investigator. Obtain and document informed consent per ICH/GCP and site SOPs. Timely, clean data entry according to ALCOA principle (“Attributable, Legible, Contemporaneous, Original and Accurate”). Prepare for monitoring visits: All Source Documents organized and readily available. All outstanding items from prior monitoring visit are resolved. No open queries from prior visit. Temperature and accountability logs readily available. Ongoing Study oversight and management: Plan subject visits according to protocol specific visit schedule. No protocol deviations due to out of window procedures. Communication with location administration to make sure space and other resources are available as needed. Reporting of Adverse and Serious Adverse Events to IRB and Sponsor in accordance with reporting guidelines. Dispensing/collecting study medication and providing accurate Investigational Product accountability. Collecting and processing subject laboratory specimens according to protocol. Completing case report forms (CRFs) and other patient tracking information (either electronic or manual) accurately and on a timely basis as assigned. Maintaining a thorough understanding of all data collection instruments and collecting data accurately and according to protocol. Perform other duties and responsibilities as required, assigned, or requested. Qualifications: Bachelors' degree required; Nursing or Health Science preferred. Bilingual preferred (Spanish). Minimum 2 years' experience as a clinical research coordinator. Therapeutic area experience in CKD, nephrology, or vascular access a plus. Knowledge of and adherence to Good Clinical Practice (GCP), IATA and FDA regulations. Must be able to do basic clinical procedures such as: blood work, vitals, height, weight, etc. Must be able to do an ECG. Travel to Investigator meetings or other study locations is expected with this position. Travel might be outside the local area and overnight.

**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.

Job Description Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Assistant is an entry level clinical position and is designed to fully integrate the individual in the Care Access Research process while learning the skills necessary to be a Clinical Research Coordinator. This position has potential growth and advancement within the Care Access Research organization. How You'll Make An Impact Ability to understand and follow institutional SOPs Participate in recruitment and pre-screening events (may be at another location) Assist with preparation of outreach materials Identify potential participants by reviewing medical records, study charts and subject database Assist with recruitment of new participants by conducting phone screenings Request medical records of potential and current research participants Schedule visits with participants, contact with reminders Obtain informed consent per Care Access Research SOP, under the direction of the CRC Complete visit procedures as required by protocol, under the direction of the CRC Collect, process and ship specimens as directed by protocol, under the direction of the CRC Record data legibly and enter in real time on paper or e-source documents Request study participant payments Update all applicable internal trackers and online recruitment systems Assist with query resolution Assist with administrative tasks such as copying, scanning, filing, mailing, emailing, etc. Assist with maintaining all site logs Assist with inventory and ordering equipment and supplies Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. Maintain effective relationships with study participants and other care Access Research personnel. Interact in a positive, professional manner with patients/participants, sponsor representatives, Investigators and Care Access Research personnel and management. Communicate clearly verbally and in writing. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. The Expertise Required Ability and willingness to work independently with minimal supervision Ability to learn to work in a fast-paced environment Excellent communication skills and a high degree of professionalism with all types of people Excellent organizational skills with strong attention to detail A working knowledge of medical and research terminology A working knowledge of federal regulations, Good Clinical Practices (GCP) Critical thinker and problem solver Friendly, outgoing personality with the ability to maintain a positive attitude under pressure Contribute to team and site goals Proficiency in Microsoft Office Suite High level of self-motivation and energy An optimistic, "can do" attitude Certifications/Licenses, Education, and Experience: A minimum of 1-year recent working experience as a Medical Assistant, EMT, LPN, Clinical Research Assistant or Phlebotomist. Phlebotomy Experience and Proficiency Required Some Clinical Research experience preferred California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health How We Work Together Location: This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal ( Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. The expected salary range for this role is $19.00 - $33.00 USD per hour for full time team members. Benefits & Perks (US Full Time Employees) Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************

Sr. Clinical Research Coordinator - (2500032W) 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 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 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 Cancer & Immunology RsrchPosition Status: R (Regular) - FT - Full-TimeShift: DayWork Schedule: 40Job Posting: Nov 25, 2025, 6:11:53 PMFull-Time Salary Range: 54516. 8 - 90854. 4