Clinical Research Associate Jobs in Leesburg, VA

Head of Research Services page is loaded Head of Research ServicesApply remote type Hybrid locations Law Center time type Full time posted on Posted Yesterday time left to apply End Date: September 30, 2025 (30+ days left to apply) job requisition id JR22194 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 Head of Research Services - Georgetown University Law Library The Head of Research Services is responsible for the planning, development, implementation. and administration of the Research Services department in its charge to support the individual scholarly and educational pursuits of Georgetown Law faculty and the research needs of the Law Center's administrative leadership team serving the Office of the Dean. In this capacity, the Head of Research Services trains, supervises, and evaluates librarians, staff, and student RAs who provide research and document delivery services and who manage faculty scholarship in digital repositories. As a team, the department actively supports the research and educational missions of the Law Center in U.S., international, foreign, and comparative law; non-legal topics; and empirical research. Research Services undertakes short-term, in-depth research projects for law faculty and the Law Center's administrative leadership team which can be of significant complexity and which must be performed under strict deadlines. Typical projects for faculty include preemption checks, literature reviews and bibliographies, locating primary and secondary sources on a topic, legislative histories, and surveys of laws. Typical projects for the Law Center's administrative leadership team include assisting with data gathering and comparative law school research. In addition, the department manages the submission of faculty scholarship to digital repositories and supports the Annual Faculty Scholarship and Teaching Luncheon. The department also provides instructional programs focused on faculty and staff, such as training for Faculty Research Assistants. The Head of Research Services participates in general Law Library operations by evaluating and selecting materials for the Law Library's collection in assigned subject areas, participating in the reference desk rotation, holding individual research consultations, and authoring and maintaining assigned research guides. Work Interactions This position reports directly to the Associate Director for Research and User Services. Currently, 3 full-time librarians and 2 full-time staff positions report directly to the Head of Research Services. In addition, up to 10 student employees serving as Law Library RAs report to this position. The Head of Research Services serves as the Law Library's representative and is a key contact for faculty and administrators, interacting with them on a regular basis to connect them to the Law Library's services. The Head of Research Services works with the Research Services librarians, staff, and student RAs to ensure research and document delivery projects are completed expeditiously and accurately. The department's maintenance of the Faculty Scholarship Database provides faculty with assistance in tenure and promotion, and the department's posting of their scholarship promotes the reputation of Georgetown Law. This position works closely with the Heads of Reference, International and Foreign Law, and Access Services, as well as the Collection Development Librarian. In addition, the Head of Research Services interacts with diverse groups and individuals outside of the Law Library, including Law Center Administration, the Office of Faculty Support, the Office of Career Strategy, and the Lateral Appointments Committee. Work Mode Designation This position has been designated as Hybrid 4 Day. 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: ************************************************** . Requirements and Qualifications Required: Master's degree from an ALA-accredited school of library and/or information studies (or non-U.S. Master's degree equivalent). Five or more years of law library or academic library experience (including supervisory experience). Knowledge of standard library practices and procedures. Knowledge of legal and interdisciplinary research sources and methods, including international, foreign, and comparative law as well as empirical research. Strong project management skill and the ability to manage multiple priorities and tasks under tight deadlines. Strong oral and written communication skills. Preferred: J.D. from an ABA-accredited law school (or non-U.S. J.D. equivalent). Academic law library experience. Teaching experience. Please submit a cover letter and resume. Preferably these documents should be combined into a single PDF. Pay Range: The projectedsalary or hourly pay range for this position which represents the full range of anticipated compensation is: $66,783.00 - $126,720.23 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 resumefor 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 clickhere for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at ************ ********************** . 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 . Similar Jobs (1) Head of Digital Initiatives - Georgetown University Law Centerremote type Hybrid locations Law Center time type Full time posted on Posted 30+ Days Ago time left to apply End Date: July 31, 2025 (30+ days left to apply) About UsSpirit of Georgetown Grounded in our Jesuit, Catholic identity, the Spirit of Georgetown undergirds everything we do. Watch this video to learn more. HR CARES Learn how HR CARES for faculty and staff, nurturing an environment of mutual respect where imaginations flourish and ideas are realized to positively impact the world. 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 . #J-18808-Ljbffr

Who we are REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities. The opportunity As a Clinical Research Associate (CRA), you will be responsible for the support and coordination of the logistical aspects of clinical trial management, site management, data review & cleaning according to FDA regulations, Good Clinical Practice (GCP) and relevant SOPs. You'll act as a pivotal point of contact for the clinical trial team and assist with the coordination of activities associated with the start-up, conduct, and close-out of clinical trials and other duties as assigned. What you'll be doing Under moderate supervision, support and coordinate logistical aspects of clinical trials Assist in the development and editing of study-related materials (e.g. consent forms, study binders, site study aids) Assist with preparation of training workshops, Investigator/Advisory Board meeting materials Assist with all phases of clinical trial activities (e.g. start-up, conduct, and close-out) Develop study tracking tools (e.g. site lists, enrollment tracking, vendor spreadsheets) Maintain tracking spreadsheets/databases and provides routine reports/dashboards to study team members Request PO independently, may review invoices with oversight from Clinical Project Manager (CPM) Track essential documents and maintain/review the eTMF under the guidance of CPM. Assist 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 Assist the CPM with the review of clinical database and management of flow of data, including but not limited to facilitating resolution of queries Assist 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) Assist with filing and management of the Electronic Trial Master File (eTMF) Distribute meeting agendas, prepare and distribute 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 Bachelors degree required; scientific discipline or related healthcare field is strongly preferred Minimum 1 years clinical research experience (e.g. pharmaceutical, biotechnology, CRO healthcare setting) Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations, GCP/ICH R2Demonstrate 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 MS Office including 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 Strong attention to detail and organizational skills required Ability to establish priorities, excellent sense of urgency to manage multiple tasks and deadlines $0 - $1 a year Why You Should Apply By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients. In addition, professional development is important to us. By joining our team, you'll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally. We are proud to offer a comprehensive rewards package which includes a market-competitive base salary, an annual performance-based bonus program, stock grants at all levels, and benefits such as health, dental, and vision insurance, retirement plan with 401(k) match, summer hours, and more! The estimated compensation range for this role is $90,000 to $120,000 annually. The actual salary offered to the final candidate depends on a number of factors such as relevant work experience, skills, education, and years of experience. 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.

Full-time Description A Clinical Research Associate will work closely with the Clinical Project Manager by providing support on assigned study tasks, which may include the responsibilities listed below. Assists clinical project team members with study tasks, including site ID, vendor ID, vendor oversight, site payments, budget, and financial management Oversees study start-up and site management for assigned studies. Identifies areas requiring follow-up and improvement at each clinical study site and recommends and implements corrective action Reviews regulatory documentation in preparation for site activation Review data issues with clinical sites and work to resolve and document the resolution Reviews and approves clinical site monitoring reports and other supporting documentation. Escalates site issues as needed to CPM; assists with management and oversight of on-site monitoring activities Develop site communications as needed, including newsletters and study-wide communication notices, FAQs Prepares for and attends project team meetings and provides updates on project status and site-specific performance Draft study-specific project plans Oversees TMF set-up, maintenance, and quality control checks for assigned studies Completes remote and on-site monitoring visits for assigned clinical sites Completes IRB submissions Coordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate Assists in preparation for advisory board and investigator meetings and training materials; presents or assists in presentation Proactively identifies project issues and contributes to problem resolution Works collaboratively and effectively in a project team in both outsourced and internally managed clinical study environments Contributes to the development of internal Clinical Operations systems to improve business processes Other duties as required Requirements Education and Experience: Bachelor's degree or equivalent experience. At least 3 years' experience in a function that can be related to pharmaceutical development Preferred previous CTA or CRA experience Life sciences or medical background is required Required Skills and Abilities: The ability to work with cross-functional teams in a matrix environment is a must Strong organizational and time management skills; detail-oriented Excellent interpersonal and communication skills Proficiency with Microsoft Outlook, Excel, Word, PowerPoint, and Project Other: Ability to travel up to 20% Authorized to work in the United States without Visa sponsorship Work Environment & Physical Requirements: Prolonged periods of sitting at a desk and working on a computer Occasional standing, walking, and reaching within the office environment Ability to lift up to 15 pounds at times Ability to perform essential job functions with or without reasonable accommodation

Overview Join the HJF Team! HJF is seeking a Research Associate I to support the Suicide Care, Prevention, and Research (CPR) Initiative in the Medical and Clinical Psychology (MPS) department within the Uniformed Services University (USU) in Bethesda, Maryland. This position is located at the Suicide CPR Initiative office in Rockville, Maryland (HJF Headquarters Building) and the incumbent will be expected to work a hybrid schedule, on-site 3 days per week. The Research Associate I will serve as a member of a multidisciplinary team and examine topics pertaining to military mental health and suicide prevention. One primary function of the Research Associate I will be to review and code records belonging to military suicide decedents and contribute to the preparation of executive summaries and timelines for each record. The ideal candidate will have prior military experience and/or prior research experience with military populations. This position will be in support of the Suicide CPR Initiative, previously known as the Laboratory for the Treatment of Suicide-Related Ideation and Behavior, which was established in 2006. Dr. Holloway, the Director of the Suicide CPR Initiative, is a clinical psychologist and an intervention scientist who is primarily interested in developing and empirically evaluating novel interventions for suicide risk reduction. The Suicide CPR Initiative is strategically in a unique position to focus on the problem of military suicide, given its origins at USU and its established partnerships with the Department of Defense and Veterans Affairs, as well as national and international collaborators and stakeholders. Overall, the mission of the Suicide CPR Initiative is threefold: CARE: To develop effective interventions targeted at reducing suicidal thoughts and/or behaviors; PREVENTION: To save lives through education, intervention, science, and advocacy; RESEARCH: To advance suicide intervention science and practice. The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals. This is a 1-year position, with the possibility of extension given funding availability and the ongoing needs of the program. Note: This site requires that the incumbent has lived in the US for three out of the past five years. Responsibilities Supports the planning and implementation of multiple suicide prevention research studies while maintaining compliance with established standard operating procedures under supervision. Conducts research in collaboration with investigators and other staff; applies quality control measures as outlined/required by the protocol; contributes to the collection and organization of data; performs basic data entry, coding and analysis. Serves as a coder for military suicide death reviews, and contributes to the preparation of written executive summaries and timelines for each record; makes detailed observations regarding military suicide decedent records. Conducts scientific literature searches using Pubmed, PsychInfo, or other databases; summarizes and references relevant articles. Performs administrative duties such as: developing protocol manuals and data collection instruments; maintaining study database and files; maintaining research project records. Assists with the preparation of manuscripts, reports, and presentations including editing and formatting documents. Serves as a member of a multidisciplinary team; participates in regular meetings with other lab staff, graduate students, and collaborators. May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role. Qualifications Education and Experience Master's Degree. Preference for degrees in social sciences or related fields. Minimum of 0-2 years' experience required Required Knowledge, Skills and Abilities Prior experience in a research environment, as well as an interest in suicide prevention research. Prior military service and/or experience working within military settings highly preferred. General understanding of clinical research design and execution required, including familiarity with relevant scientific principles and procedures. Excellent communication and interpersonal skills, with the ability to foster collaboration and contribute effectively within a multi-disciplinary team. Excellent organizational and project management skills, with the ability to multitask effectively and meet project deadlines. Ability to obtain and maintain a T1/Public Trust background check Physical Capabilities Ability to stand or sit at a computer for prolonged periods. Work Environment This position will take place primarily in an office setting. Compensation The annual range for this position is $50,100-$58,000. Actual salary will be determined based on experience, education, etc. Benefits HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more. Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1. 35(c) Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Bacteriology Research Scientist ***This position requires an active Secret clearance or the ability to obtain a Secret clearance to be considered. *** requires being a U.S. citizen. As a Bacteriology Research Scientist, you will conduct and assist in both basic and applied research focused on specified bacterial threats. This role is crucial for advancing our understanding and development of medical countermeasures against significant infectious diseases such as plague, tularemia, melioidosis, glanders, anthrax, and Q-fever. Compensation & Benefits: Pay commensurate with experience. Pay range- $80k- $85k Full-time benefits include Medical, Dental, Vision, 401K, and other possible benefits as provided. Benefits are subject to change with or without notice. Bacteriology Research Scientist Responsibilities Include: Plan, manage, and execute complex in vitro and in vivo studies under BSL-2 and BSL-3 conditions, using advanced techniques like organoids and organ-on-a-chip systems. Perform animal manipulations, including observations, injections, blood draws, and euthanasia under various biosafety levels. Analyze clinical readouts from studies, including radiographs, clinical chemistry, and hematology of laboratory animals. Draft animal protocols, study protocols, technical reports, and peer-reviewed manuscripts. Maintain compliance with Good Laboratory Practice (GLP) regulations and ensure accurate documentation and quality review of raw data. Manage laboratory maintenance, safety compliance, and assist in routine laboratory upkeep. Maintain accountability and up-to-date records of Biological Select Agents and Toxins (BSAT) and Investigational New Drugs (INDs) applications. Performs other job-related duties as assigned. Bacteriology Research Scientist Qualifications: Ph.D. or D.V.M. with at least two years of relevant research experience, or a Master's degree with seven years of relevant research experience in bacteriology, animal physiology, or related fields. Demonstrated experience in designing, executing, and analyzing complex scientific studies, especially under regulatory frameworks such as the FDA-Animal Rule. Preferred experience in high-containment facilities (BSL-3 and ABSL-3). Must pass the pre-employment qualifications of Cherokee Federal. Must be able to attain Biosurety Personnel Reliability Program (BPRP) and Controlled Substances Personnel Reliability Program (CS-PRP) status. Must hold a secret clearance or have a background that will allow obtaining a secret clearance. Bacteriology Research Scientist Skills: Proficient in bacterial assays, animal procedures, and data analysis. Strong organizational skills and attention to detail. Excellent written and verbal communication skills. Ability to work independently and collaboratively in a high-pressure environment. Company Information: Cherokee Nation Integrated Health (CNIH) is a part of Cherokee Federal, a division of tribally owned federal contracting companies owned by Cherokee Nation Businesses. As a trusted partner for more than 60 federal clients, Cherokee Federal LLCs are focused on building a brighter future, solving complex challenges, and serving the government's mission with compassion and heart. To learn more about CNIH, visit cherokee-federal.com. #CherokeeFederal #LI-SH1 Cherokee Federal is a military-friendly employer. Veterans and active military personnel transitioning to civilian status are encouraged to apply. Similar searchable job titles Microbiology Research Scientist Infectious Disease Scientist Clinical Research Scientist Biological Scientist Molecular Biologist Pathogen Research Scientist Biodefense Research Scientist Keywords Bacteriology Infectious Diseases Microbiology BSL-3 (Biosafety Level 3) GLP (Good Laboratory Practice) Animal Models In Vitro and In Vivo Clinical Trials Pathogenesis Antimicrobial Resistance Biodefense Epidemiology PCR (Polymerase Chain Reaction) Legal Disclaimer: All qualified applicants will receive consideration for employment without regard to protected veteran status, disability, or any other status protected under applicable federal, state, or local law. Many of our job openings require access to government buildings or military installations. Candidates must pass pre-employment qualifications of Cherokee Federal.

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. R&D Supplier Governance Monitor **What you will do** Let's do this. Let's change the world. In this vital role you will support Amgen-sponsored clinical trials worldwide. Reporting to the Senior Manager of R&D Supplier Governance, you will help ensure the quality and integrity of processes and data generated by service suppliers for these trials. Additionally, as part of the RDSG team, you will support programs and study teams, collaborate with senior management, and partner with internal stakeholders and suppliers for process improvement. We support our clinical trials around the world. Come join an outstanding team that delivers for our study teams and our patients! Potentially up to 25% travel domestic and/or international. Responsibilities + Monitoring the collection, processing, and analysis of data by Service Suppliers for Amgen sponsored clinical trials + Monitoring and evaluating Supplier compliance and data quality + Tracking corrective actions in relation to monitoring issues and audit findings; escalates as appropriate + Developing professional relationships with service suppliers and with Amgen stakeholders + Driving continuous improvement + Communicating identified issues to key stakeholders at the supplier and at Amgen + Facilitating and implementing supplier governance meetings, operating reviews, monitoring key performance indicators and perform issue management + Build and maintain relationships with key internal and external partners, including study teams, functional leads, procurement, quality, compliance, and suppliers + Support business functions with evaluation, selection, and startup of suppliers Ensure quality oversight of vendors though: + Working with suppliers and internal customers (typically up to Director level) to identify, lead, raise and resolve issues related to supplier performance + Measuring supplier performance and reporting performance feedback to internal partners and supplier **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 monitor with these qualifications. **Basic Qualifications:** + Doctorate degree OR + Master's degree & 2 years of relevant experience OR + Bachelor's degree & 4 years of relevant experience OR + Associate's degree & 8 years of relevant experience OR + High school diploma / GED & 10 years of relevant experience **Preferred Qualifications:** + BA/BS/BSc in the sciences or RN + 7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical trial experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company). + Experience at, or oversight of, technical suppliers (imaging and/or adjudication). + Experience working in a global, matrix organization. + Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines. + Project management/project planning experience. + Proficiency in anticipating and resolving problems. + Experience writing and communicating clearly on scientific and clinical issues. + Excellent interpersonal, organizational, supervisory skills. + Professional collaboration and leadership skills. + Experience in compliance, quality, and audit What you can expect from 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. 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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Lightship is the virtual-first provider that is perfecting the way clinical trials get done. Because clinical research plays such a vital role in bringing life-enhancing and lifesaving innovations to market, Lightship pursues operational excellence to clinical studies. Our end-to-end hybrid delivery model, our diversity of skillsets, and inhouse care team ensure sponsor success and the best possible patient experience. With a problem-solving mindset, we strive to make every clinical trial better than the last. Operational excellence is not a goal, but a way of doing things at Lightship. A successful candidate will possess a willingness and desire to work independently without significant supervision. Lightship expects each individual to anchor their availability in the standard operating hours for their geographic location, however, true to our values of inclusion and flexibility, this role, along with all others at Lightship, may be asked to flex work hours to accommodate study activities, based on business need. In practice, this may translate to days that have a slightly earlier start or evenings that have a slightly later end. Culturally, we aim to balance the ability to operate across time zones with respect for each individual's daily life. This is a 9-month contract opportunity based in College Park, Maryland that will require travel up to 90% to conduct studies on our Mobile Research Unit. The MRU (Mobile Research Unit) Clinical Study Coordinator is responsible for: Coordinating and conducting study activities with patients and serving as the primary point of contact for patients, investigators, and study personnel, including but not limited to: Patient scheduling Pre-screening activities (e.g., phone screening) and other recruitment activities as approved by the IRB Coordinating research procedures and assessments; keeping track of all planned and completed study visits Organizing patients', investigators', home health personnel, and any relevant vendors' (e.g., drug management vendor) schedules to complete study visits within protocol windows Collecting and transporting IP as needed Completing sample processing as needed Assisting in the informed consent process as requested and delegated Alerting investigator / sub-investigator / designated personnel when patients report potential adverse events and ensuring proper documentation and follow-up of such events Educating patients on study procedures; responding to patients' questions in a compassionate and cultural / age-appropriate manner; triaging patients' questions to the appropriate study personnel Understanding and complying with all regulations, policies, and guidelines applicable to clinical research, including GCP, FDA, and IRB requirements Adhering to study protocol and performing the assigned study tasks per delegation Tracking and reporting status of key study activities and milestones to study team (as requested) Preparing and conduct data entry, study reports (e.g., screening, enrollment, AEs, deviations) as requested Supporting process improvement initiatives, as they relate to study coordination, through the building of SOPs, working instructions, process flows etc. Maintaining meticulous accuracy in completing all study documentation (paper and electronic) and ensuring that ALCOA-C standards are upheld, including: Completing and maintaining source documentation Collecting study data and completing data entry / case report forms in various electronic systems and on paper Assisting in record retention activities after study is completed Addressing data queries and completing data corrections per Good Documentation Practices Coordinating general study activities, including: Assisting with study start-up and close out activities Assisting patients, investigators, and study personnel in troubleshooting problems with supplies, equipment, or vendors Other study-related activities as assigned The MRU (Mobile Research Unit) Clinical Study Coordinator has: Required knowledge, skills, and abilities Strong communication skills, including verbal, written, and presentational Effective problem-solving skills Calm, collected and compassionate demeanor when working with patients, and their caregivers or family members Ability to build rapport with investigators and site staff to establish effective working relationship, necessary for excellence in project delivery High level of self-motivation with a willingness to proactively address gaps and drive improvements Exceptional ability to work as part of a team and to multitask effectively Ability to function independently in a technology-enabled clinical research setting Self-monitoring capability to review, resolve and correct collected data as needed Good Documentation Practices Aptitude to update systems in a timely and accurate way Ability to be highly organized in an environment with shifting priorities Flexibility to travel if requested Education and experience 2+ years of relevant clinical research experience, required Bachelor's Degree in Life Science or healthcare-related field, or requisite combination of education, training, and experience Bilingual in English and Spanish, preferred Sample processing experience, preferred We would like to offer you: An opportunity to help re-envision how clinical research is executed with inclusivity, increased diversity and accessible at the core The chance to work with a patient-centered, clinically-oriented, collaborative team to support in the delivery of enterprise grade virtual-first clinical research solutions at scale An unmatched opportunity to grow as part of an established startup with industry veterans, high-caliber investors, and a massive market opportunity Great compensation Generous benefits package, including: Top notch healthcare (medical, dental, and vision) for you and your family. Paid holidays and bereavement to help support work life balance. A 100% 401(k) company match for up to 4% of eligible contributions with an immediate vesting. Company provided laptop, your choice of a PC or a Mac Monthly stipend for internet and phone expenses Short & long-term disability Life insurance and More! The base salary range for this role is between $50,000 - 65,000, depending on education, skills, and experience. To determine our compensation, we use a market-based approach that is geographically neutral. We believe that this demonstrates our company value of ‘believing in people' - valuing the outputs and performance of each team member. Please note: For the safety of our patients and each other, all positions at Lightship that require travel, in-person participation, or are patient-facing, do require vaccination against COVID-19. Our commitment to diversity & inclusion: Lightship is an equal opportunity employer and promotes a diverse and inclusive workplace. Lightship considers all applicants without regard to race, color, religion, creed, national origin, age, sex, marital status, ancestry, disability, veteran status, gender identity, genetic information, sexual orientation, or any other status protected by applicable law. EEO is the Law Lightship is an E-Verify employer. Find out more here: Right to Work Poster E-Verify Participation Poster #jobs #careers #nowhiring #hiringnow #LI-remote

Under the guidance of the Clinical Trial Manager, the Clinical Research Coordinator (CRC) III functions independently and proficiently with minimal oversight and is responsible for the complete coordination of assigned clinical research activities of all phases and all levels of complexity, including investigator-initiated or other high profile research. Demonstrates competence in clinical research skills, problem solving, priority setting and supports less experienced staff. Required to enter study and/or research participant data into the Clinical Trial Management System (CTMS) as applicable. Primary Duties and Responsibilities Oversees, prepares, submits and maintains all regulatory submissions (e.g., new studies, annual review, amendments) accurately and within a timely manner; periodically self-audits records to ensure audit-readiness; ensures the appropriate delegation of study related tasks (i.e., Delegation of Authority).Possesses basic understanding of clinical trial endpoints and analytical ability sufficient to evaluate data.Oversees the informed consent process and reviews consent form with research participants and provides time for research participant to consider study participation; executes the informed consent process according to Good Clinical Practices (GCPs), procedures and other applicable rules, regulations and policies; educates new staff and research participates about protocol expectations and the conduct of clinical trials.Ensures all research participant encounters are updated as appropriate and within one (1) business day in a recognized electronic system/database (e.g., Clinical Trial Management System CTMS; enter data into various auditable databases or electronic data-capture systems (e.g., REDCap); oversees data entry and validation to ensure accuracy and completeness of the data collection process; supports data management process for clinical research projects, including addressing data queries and outstanding data queries from data managers, project statistician and sponsors; completes and submits case report forms on as close to a real time basis" as possible.Works with study team as needed to define biospecimen collection, processing and storage procedures; trains others as needed to collect and label samples as instructed and delivers or processes samples in accordance with protocol; communicates with manager, investigator and sponsor regarding laboratory findings and recognizes common laboratory values and alerts; maintains current Occupational Safety and Health Administration (OSHA) training regarding Bloodborne Pathogens and International Air Transportation Association (IATA) training for routine packing, labeling and transporting of biological materials.Attends investigator meetings as required or as requested by the investigator and assists the investigator in communication of study requirements to all individuals involved in the study and provides appropriate training for study teams members; documents date of training and signatures of study personnel trained on study specific training log as appropriate; alerts the investigator when the research participant's safety is in jeopardy, there is a protocol deviation, or when the research participant request premature study termination.Randomizes research participants using an interactive voice response system or other system as applicable and maintains all test article records as required by regulatory agencies and sponsor's requirements; prepares emergency use or expanded access reports as applicable.Optimizes the safety of research participants by monitoring and reporting any non-serious or serious adverse events to the investigators and other members of the study team; presents investigator with relevant information for determination of seriousness, causality and intervention; assists investigator (as appropriate) in classifying adverse events (e.g., serious, moderate, unexpected); acts on investigator's recommendation for adverse event intervention (e.g., stop test article, call research participant, re-test, treat); maintains follow-up to determine resolution of adverse event.Collaborates with the investigator and administrative leadership to prepare a categorized budget and justification; confirms the accuracy and completeness of budgeted costs; reviews and develops familiarity with the executed contract to ensure that the study is in compliance with all terms and conditions, health and safety precautions for research participants and any financial terms and conditions.Understands and complies with rules for billing Medicare, Medicaid and third party payors for services, drugs, devices, tests and procedures rendered in the clinical research context; oversees and ensure registration of each research participant according to the billing matrix/billing plan and ensures billing of study procedures and/or visits to the appropriate funding source.Oversees the return or dispose of unused supplies per sponsor requirement; reconciles test article accountability; documents research participants who are lost to follow-up or who have dropped out (e.g., causes, contact efforts); assists in the preparation for a potential routine pre-market approval (PMA) FDA inspection as applicable.Supports an investigator-initiated IND or IDE study; prepares for internal or external audits and/or FDA inspections; assists and facilitates research and/or project team meetings; coordinates multi-center studies as applicable; acts as a liaison for research participants, investigators, sponsors and healthcare professionals and compose clear, precise and detailed correspondence; schedules and leads site qualification, study initiation, monitoring and close-out visits;Ensures that all key personnel engaged in the research project have met training requirements in accordance with Federal regulations, institution and sponsor policies and procedures; maintains effective and ongoing communication with sponsor, multidisciplinary, ancillary and inter-professional research teams; understands and contributes to scientific center goals and growth and maintains knowledge in the field through attending related project meetings, reading related literature and maintains professional associations as appropriate. Minimum Qualifications Education * Bachelor's degree, an allied health or related professional degree required, or equivalent work experience required Experience * Experience as a clinical research coordinator in the clinical research field required * 3-4 years Clinical research or related experience required * Research and/or work experiences that demonstrate aptitude for research facilitation required Knowledge, Skills, and Abilities * Excellent verbal and written communication skills. * Strong communication and organizational skills. * Proficient computer skills. This position has a hiring range of $63,793 - $113,318

The primary responsibility of the Clinical Research Coordinator is to manage oncology patients participating in pharmaceutical sponsored clinical trials. This position will be responsible for screening, enrolling and following study patients to ensure protocol compliance. Successful candidates will have prior experience managing patients on clinical trials following Good Clinical Practice and FDA regulations. RN preferred. Work is performed under the general direction of the Director Research Nursing. Essential Duties and Responsibilities : Recruits subjects for clinical trials through a variety of methods. Screens potential subjects for eligibility to clinical trials including a careful review of the patient's past medical history and a review of current findings. Educates staff nurses about proper administration and expected side effects of protocol therapy. Educates patients about protocol therapy including when medications are to be taken, what side effects to look for and actions to take in event that side effects occur. Serves as a liaison between the Research Team and the non-research members of the West Clinic to ensure compliance with the clinical trial requirements. Protects the rights, safety and welfare of the patients. Strives to maintain harmonious relationships with clinic personnel, medical staff, patients/caregivers and the public. Obtains and maintains informed consents of each patient for the duration of a study. Reviews newly-activated protocols, amendments, notices, suspensions and terminations. Responsible for maintaining a current knowledge of the Code of Federal Regulations. Interfaces with Physicians, Physician Nurses, Chemotherapy Nurses, Radiology, Medical Records, Front Desk/Scheduling, Phlebotomy, Laboratory, Insurance and Pharmacy regarding research. Maintains a professional approach respecting the dignity and confidentiality of patients. Maintains a good attendance record and reports on time for work. Maintains a professional attitude and appearance. Performs other duties as assigned. Qualifications/Experience: Associates degree or equivalent from two-year college or technical school; or a minimum of 1-2 years related experience and/or training; or equivalent combination of education and clinical experience: or must have successfully completed 1 year as an Associate Clinical Research Coordinator 1. RN certification preferred. Required Knowledge, Skills and Abilities Must have excellent organization and follow-up skills Must have excellent verbal and written communication skills Must have excellent problem-solving skills; ability to organize and prioritize work assignments Ability to handle multiple priorities in a fast-paced environment Ability to analyze situations and respond in a timely manner Ability to participate in multi-functional teams Ability to establish and maintain effective working relationships within the West Cancer Center Must be proficient in computer applications including word processing and email Ability to work near toxic or caustic chemicals Ability to read, analyze and interpret financial reports, government regulations, common scientific and technical journals and legal documents Ability to respond verbally and in writing to common inquiries or complaints from customers, regulatory agencies or members of the business community Ability to effectively present information to top management, large employee groups and/or public groups Ability to calculate figures and amounts such as discounts, interest, commissions, percentages, BSA, ANC, drug calculations, area, circumference, and volume Ability to apply concepts of basic algebra and geometry Ability to define problems, collect data, establish facts, draw valid conclusions Ability to interpret an extensive variety of technical complex instructions and deal with several abstract and concrete variables Ability to sit, stand, walk, reach, climb or balance, stoop or crouch, hand/wrist use, talk, see and hear for extended periods of time Ability to lift up to 10 lbs. Additional hours may be required Travel may be required

The Global and Linguistic Studies Academy Coordinator serves as the LCPS leader of the Academy of Global and Linguistic Studies at the assigned school and is responsible for the total operation of that program, including collaboration with division leadership and the principal. The Global and Linguistic Studies Academy Coordinator shall provide instructional leadership and administrative skills for the educational development of students and staff and promote appropriate family and community awareness. The Global and Linguistic Studies Academy Coordinator will support outreach and instruction while serving as a parent liaison and liaison to LCPS. Extensive networking with school-business partners in LCPS and with economic and political leaders across the DC Metro Area is also a key responsibility. Roles and Responsibilities The following information is intended to describe the overall nature and scope of the work being performed. This is not a comprehensive listing of all responsibilities or tasks; work may differ and other work may be assigned when deemed appropriate. Assists division leaders in the implementation, supervision, and evaluation of the Academy of Global and Linguistic Studies; in the evaluation of instructional and classified personnel; in the departmental budgeting process and the acquisition of supplies and supplementary materials for instructional use; in the coordination of programs and services related to Academy of Global and Linguistic Studies instruction Collaborates with the Director of Academic Programs, Director of Teaching and Learning K-12, Supervisor of Social Science and Global Studies, and Supervisor of World Languages and Cultures to provide recommendations and guidance Coordinates and supervises all LCPS staff and central-level activities and programs related to the Academy of Global and Linguistic Studies Outreaches with school-based staff at the middle and high school level to build awareness and interest in the Academy of Global and Linguistic Studies Partners with the Division of Teaching and Learning in meeting curricular, co-curricular, credentials, work-based learning experiences, and instructional needs, and develops plans to meet those needs through coaching and professional learning Develops long and short-range plans to provide coaching and professional learning opportunities Assists the Division of Teaching and Learning and Student Services on items related to the Academy of Global and Linguistic Studies such as program admission, transportation, or school counseling Serves with parent, faculty, and student groups as requested in advancing educational and related activities and objectives Qualifications Below are the minimum qualifications for this job. Equivalent combinations of education and experience are also acceptable. Education Bachelor's degree Experience Five years experience as a teacher or administrator at the secondary or post-secondary level Licenses and Certifications Knowledge, Skills and Abilities Ability to envision, articulate, and implement a clear strategic direction for the Academy of Global and Linguistic Studies. Possesses knowledge and effective skills in curriculum development, instructional practices, interpretation of data, and budget development. Knowledge of curriculum design principles. Strong leadership skills to manage a complex program, guide staff, and work across departments. Ability to collaborate effectively with diverse stakeholders. Skilled in fostering an inclusive, respectful, and culturally sensitive learning environment. Skilled in grant writing and building partnerships with external organizations. Physical Requirements The following provides a brief description of physical requirements for this job: While performing the duties of this job, the employee is regularly talking, expressing or exchanging ideas by means of the spoken word. The employee must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly. The employee must possess normal cognitive abilities including the ability to learn, recall and apply certain practices and policies. Frequently sitting and/or remaining in a stationary position for long periods of time. Exerting up to 25 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. Reports to: Supervisor, Social Science & Global Studies FLSA Status: Exempt Months/Days/Hours: 12 months/ 248 days/ 8 hours Salary Level: Universal 20 Salary Scale: ********************************* Salary Range: $109,393 - $177,439 Remote Work Eligible: No

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Responsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Compensation: $26-30/h. Essential Responsibilities and Duties: Assists Director with coordinating all aspects of patient involvement from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Documents adverse events, protocol deviations, and other unanticipated problems appropriately. Reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: High school graduate or equivalent; Bachelor's Degree, preferred. 1-2 years of coordinating experience, high volume of clinical trials, preferably with psych/CNS trials Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Rarely lift over 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

What We Do Care Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers. Who We Are We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations. Position Overview The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. What You'll Be Working On Duties include but not limited to: Patient Coordination * Prescreen study candidates * Obtain informed consent per Care Access Research SOP . * Complete visit procedures in accordance with protocol. * Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. * Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. * Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. * Prioritize activities with specific regard to protocol timelines * Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. * Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. * Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) Documentation * Record data legibly and enter in real time on paper or e-source documents * Accurately record study medication inventory, medication dispensation, and patient compliance. * Resolve data management queries and correct source data within sponsor provided timelines * Assist regulatory personnel with completion and filing of regulatory documents. * Assist in the creation and review of source documents. Patient Recruitment * Assist with planning and creation of appropriate recruitment materials. * Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. * Actively work with recruitment team in calling and recruiting subjects Other Responsibilities * Review and assess protocol (including amendments) for clarity, logistical feasibility * Ensure that all training and study requirements are met prior to trial conduct. * Communicate clearly verbally and in writing. * Attend Investigator meetings as required. * Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) * Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. * Maintain effective relationships with study participants and other care Access Research personnel. Scope of Role * Autonomy of Role: Work is performed under general supervision * Direct Reports: No Physical Requirements * Physical demands associated with onsite duties include: * Walking-20% * Standing-20% * Sitting-20% * Lifting (up to 25lbs)-20% * Driving-20% Travel Requirements * This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives. o Type of travel required: Regional (within 100 miles) What You Bring Knowledge, Skills, and Abilities: * Ability to understand and follow institutional SOPs. * Excellent working knowledge of medical and research terminology * Excellent working knowledge of federal regulations, good clinical practices (GCP) * Ability to communicate and work effectively with a diverse team of professionals. * Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail * Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. * Critical thinker and problem solver * Friendly, outgoing personality; maintain a positive attitude under pressure. * High level of self-motivation and energy * Excellent professional writing and communication skills * Ability to work independently in a fast-paced environment with minimal supervision. Certifications, Education, and Experience: * Bachelor's Degree preferred, or equivalent combination of education, training and experience. * A minimum of 1-year prior Clinical Research Coordinator experience required * Recent phlebotomy experience required Licenses: * 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 Benefits (US Full-Time Employees Only) * 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 serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to 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 value diversity and believe that unique contributions drive our success. At Care Access, every day, we are advancing medical breakthroughs. We're uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We're proud to advance these breakthroughs and work with the big players while engaging with the physicians and caring for patients. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to 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. Employment Statement Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.

div class="iCIMS_JobContent" h2 class="iCIMS_InfoMsg iCIMS_InfoField_Job" /h2 div class="iCIMS_InfoMsg iCIMS_InfoMsg_Job" div class="iCIMS_Expandable_Container" div class="iCIMS_Expandable_Text" p style="margin: 0px;"span style="font-size: 10pt;"Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step./span/pp style="margin: 0px;" /pp style="margin: 0px;"span style="font-size: 10pt;"As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity./span/pp style="margin: 0px;" /pp style="margin: 0px;"span style="font-size: 10pt;"Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program./span/pp style="margin: 0px;" /pp style="margin: 0px;"span style="font-size: 10pt;"strong Summary:/strong/span/pp style="margin: 0px;"span style="font-size: 10pt;"The Clinical Research Assistant assists the Clinical Operations Team in a multi-functional capacity to carry out all assigned tasks associated with the collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities./span/p /div /div /div h2 class="iCIMS_InfoMsg iCIMS_InfoField_Job" Responsibilities /h2 div class="iCIMS_InfoMsg iCIMS_InfoMsg_Job" div class="iCIMS_Expandable_Container" div class="iCIMS_Expandable_Text" p style="margin: 0px;"span style="font-size: 10pt;"strongspan style="font-family: verdana, geneva;"span style="font-size: 10pt; color: windowtext;"Duties/Responsibilities:/span/span/strong/span/pullispan style="font-size: 10pt;"Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity's SOPs/span/lilispan style="font-size: 10pt;"Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations/span/lilispan style="font-size: 10pt;"With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc) within scope of the protocol, local law and regulations/span/lilispan style="font-size: 10pt;"Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable/span/lilispan style="font-size: 10pt;"Track, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trial/span/lilispan style="font-size: 10pt;"Enter source data into the sponsor's and/or vendor's data portal and resolve basic queries in a timely manner under the direction of the Clinical Research Coordinator/span/lilispan style="font-size: 10pt;"Communicate with coworkers, leadership, study subjects, sponsors, CROs, and vendors under the direction of the Clinical Research Team/span/lilispan style="font-size: 10pt;"Understand good documentation practices when collecting, transferring data to sponsor/CRO data capture systems and resolving queries under the direction of the Clinical Research Coordinator/span/lilispan style="font-size: 10pt;"Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects/span/lilispan style="font-size: 10pt;"Understand basic elements of regulatory documentation required to initiate, maintain and close a clinical research trial/span/lilispan style="font-size: 10pt;"Understand and participate in patient recruiting tasks including but not limited to prescreening potential subjects for clinical research trials either via phone or in person/span/lilispan style="font-size: 10pt;"Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information/span/lilispan style="font-size: 10pt;"Ability to escalate potential patient safety issues such as adverse events, serious adverse events, and adverse events of special interest to the Clinical Research Team/span/lilispan style="font-size: 10pt;"Cleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as needed/span/lilispan style="font-size: 10pt;"Prepare source document charts, copy and/or file medical records and study related documents as required./span/lilispan style="font-size: 10pt;"Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems./span/lilispan style="font-size: 10pt;"Other duties as assigned/span/li/ul /div /div /div h2 class="iCIMS_InfoMsg iCIMS_InfoField_Job" Qualifications /h2 div class="iCIMS_InfoMsg iCIMS_InfoMsg_Job" div class="iCIMS_Expandable_Container" div class="iCIMS_Expandable_Text" p style="margin: 0px;"span style="font-size: 10pt;"strong Education/Experience:/strong/span/pullispan style="font-size: 10pt;"High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences industry/span/li/ulp style="margin: 0px;"span style="font-size: 10pt;"strong Required Licenses/Certifications:/strong/span/pullispan style="font-size: 10pt;"Phlebotomy if applicable and required by state law/span/lilispan style="font-size: 10pt;"Intramuscular dose administration and preparation if applicable and required by state law/span/li/ulp style="margin: 0px;"span style="font-size: 10pt;"strong Required Skills:/strong/span/pullispan style="font-size: 10pt;"Demonstrated knowledge of medical terminology/span/lilispan style="font-size: 10pt;"Demonstrated ability to use the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone./span/lilispan style="font-size: 10pt;"Understanding of verbal, written, and organizational skills/span/lilispan style="font-size: 10pt;"Demonstrated ability to work as a team player/span/lilispan style="font-size: 10pt;"Demonstrated ability to read, write, and speak English/span/lilispan style="font-size: 10pt;"Demonstrated ability to multi-task/span/lilispan style="font-size: 10pt;"Demonstrated ability to follow written guidelines/span/lilispan style="font-size: 10pt;"Demonstrated ability to be flexible/adapt as daily schedule may change rapidly/span/li/ulp style="margin: 0px;"span style="font-size: 10pt;"strong Required Physical Abilities:/strong/span/pullispan style="font-size: 10pt;"Sit or stand for long periods of time/span/lilispan style="font-size: 10pt;"Communicate in person and by a telephone/span/lilispan style="font-size: 10pt;"Limited walking required/span/lilispan style="font-size: 10pt;"Limited to lifting up to 30 pounds/span/li/ulp style="margin: 0px;"span style="font-size: 10pt; font-family: verdana, geneva; color: windowtext;"NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management./span/pp style="margin: 0px;" /p /div /div /div /div

Clinical Research Assistant - (250001D9) Description The Clinical Research Assistant performs a variety of research, data and clerical duties of a routine and technical nature to support the conduct of clinical research under the direction of a senior research team member. The Research Assistant 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. In this role, the Clinical Research Assistant completes tasks including identifying eligible participants under the supervision of a senior research team member, preparing necessary documents, equipment, supplies, etc. for research visits and conducting and documenting visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies. Qualifications Minimum EducationBachelor's Degree BA/BS degree in a science, technical, health-related field or another applicablediscipline. (Required) OrMinimum Work Experience0 years Experience working in a medical or scientific research setting (Preferred) 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 guidance (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 and organizes study documents. 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 and seeks and provides input when appropriate. Participant Enrollment Adheres to the IRB-approved recruitment plan. Identifies participants that meet eligibility requirements under the supervision of a senior research team member. 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. Follows procedures for documenting participant incentive distribution. Study Management 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. Conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction. Completes accurate IRB submissions within institutional timeframes. Records participant visits in the appropriate tracking system. Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner. 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 and assists in maintaining regulatory documents per sponsor and institutional requirements. 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: Ctr Clinical & Community RsrchPosition Status: R (Regular) - PT - Part-TimeShift: DayWork Schedule: WeekdaysJob Posting: May 19, 2025, 5:49:03 PMFull-Time Salary Range: 42702.4 - 71156.8

Lightship is the virtual-first provider that is perfecting the way clinical trials get done. Because clinical research plays such a vital role in bringing life-enhancing and lifesaving innovations to market, Lightship pursues operational excellence to clinical studies. Our end-to-end hybrid delivery model, our diversity of skillsets, and inhouse care team ensure sponsor success and the best possible patient experience. With a problem-solving mindset, we strive to make every clinical trial better than the last. Operational excellence is not a goal, but a way of doing things at Lightship. A successful candidate will possess a willingness and desire to work independently without significant supervision. Lightship expects each individual to anchor their availability in the standard operating hours for their geographic location, however, true to our values of inclusion and flexibility, this role, along with all others at Lightship, may be asked to flex work hours to accommodate study activities, based on business need. In practice, this may translate to days that have a slightly earlier start or evenings that have a slightly later end. Culturally, we aim to balance the ability to operate across time zones with respect for each individual's daily life. This is a 9-month contract opportunity based in College Park, Maryland that will require travel up to 90% to conduct studies on our Mobile Research Unit. The MRU (Mobile Research Unit) Clinical Study Coordinator is responsible for: * Coordinating and conducting study activities with patients and serving as the primary point of contact for patients, investigators, and study personnel, including but not limited to: * Patient scheduling * Pre-screening activities (e.g., phone screening) and other recruitment activities as approved by the IRB * Coordinating research procedures and assessments; keeping track of all planned and completed study visits * Organizing patients', investigators', home health personnel, and any relevant vendors' (e.g., drug management vendor) schedules to complete study visits within protocol windows * Collecting and transporting IP as needed * Completing sample processing as needed * Assisting in the informed consent process as requested and delegated * Alerting investigator / sub-investigator / designated personnel when patients report potential adverse events and ensuring proper documentation and follow-up of such events * Educating patients on study procedures; responding to patients' questions in a compassionate and cultural / age-appropriate manner; triaging patients' questions to the appropriate study personnel * Understanding and complying with all regulations, policies, and guidelines applicable to clinical research, including GCP, FDA, and IRB requirements * Adhering to study protocol and performing the assigned study tasks per delegation * Tracking and reporting status of key study activities and milestones to study team (as requested) * Preparing and conduct data entry, study reports (e.g., screening, enrollment, AEs, deviations) as requested * Supporting process improvement initiatives, as they relate to study coordination, through the building of SOPs, working instructions, process flows etc. * Maintaining meticulous accuracy in completing all study documentation (paper and electronic) and ensuring that ALCOA-C standards are upheld, including: * Completing and maintaining source documentation * Collecting study data and completing data entry / case report forms in various electronic systems and on paper * Assisting in record retention activities after study is completed * Addressing data queries and completing data corrections per Good Documentation Practices * Coordinating general study activities, including: * Assisting with study start-up and close out activities * Assisting patients, investigators, and study personnel in troubleshooting problems with supplies, equipment, or vendors * Other study-related activities as assigned The MRU (Mobile Research Unit) Clinical Study Coordinator has: * Required knowledge, skills, and abilities * Strong communication skills, including verbal, written, and presentational * Effective problem-solving skills * Calm, collected and compassionate demeanor when working with patients, and their caregivers or family members * Ability to build rapport with investigators and site staff to establish effective working relationship, necessary for excellence in project delivery * High level of self-motivation with a willingness to proactively address gaps and drive improvements * Exceptional ability to work as part of a team and to multitask effectively * Ability to function independently in a technology-enabled clinical research setting * Self-monitoring capability to review, resolve and correct collected data as needed * Good Documentation Practices * Aptitude to update systems in a timely and accurate way * Ability to be highly organized in an environment with shifting priorities * Flexibility to travel if requested * Education and experience * 2+ years of relevant clinical research experience, required * Bachelor's Degree in Life Science or healthcare-related field, or requisite combination of education, training, and experience * Bilingual in English and Spanish, preferred * Sample processing experience, preferred We would like to offer you: * An opportunity to help re-envision how clinical research is executed with inclusivity, increased diversity and accessible at the core * The chance to work with a patient-centered, clinically-oriented, collaborative team to support in the delivery of enterprise grade virtual-first clinical research solutions at scale * An unmatched opportunity to grow as part of an established startup with industry veterans, high-caliber investors, and a massive market opportunity * Great compensation Generous benefits package, including: * Top notch healthcare (medical, dental, and vision) for you and your family. * Paid holidays and bereavement to help support work life balance. * A 100% 401(k) company match for up to 4% of eligible contributions with an immediate vesting. * Company provided laptop, your choice of a PC or a Mac * Monthly stipend for internet and phone expenses * Short & long-term disability * Life insurance and More! The base salary range for this role is between $50,000 - 65,000, depending on education, skills, and experience. To determine our compensation, we use a market-based approach that is geographically neutral. We believe that this demonstrates our company value of 'believing in people' - valuing the outputs and performance of each team member. Please note: For the safety of our patients and each other, all positions at Lightship that require travel, in-person participation, or are patient-facing, do require vaccination against COVID-19. Our commitment to diversity & inclusion: Lightship is an equal opportunity employer and promotes a diverse and inclusive workplace. Lightship considers all applicants without regard to race, color, religion, creed, national origin, age, sex, marital status, ancestry, disability, veteran status, gender identity, genetic information, sexual orientation, or any other status protected by applicable law.

We are actively recruiting for a few experienced Clinical Research professionals to join our team at MedStar Health Research Institute in Washington, DC as a Clinical Research Coordinator II. Implements and coordinates research and administrative procedures for the successful management of clinical trials. Performs diverse administrative duties requiring analysis, sound judgment and a high level of knowledge of study specific protocols. Enters study and/or research participant data into the Clinical Trial Management System (CTMS) as applicable. Primary Duties and Responsibilities Regulatory responsibilities include the oversight and/or responsibility for the Intuitional Review Board (IRB) submissions, and other related regulatory forms (e.g., scientific review), and adhering to the timelines of the study start-up process; developing informed consent documents and other documents as applicable; supporting the safety of clinical research participants; ensureing the appropriate delegation of study related tasks (i.e., Delegation of Authority).Explains the informed consent process and the study to the research participant (e.g., purpose, duration, risks/benefits) and obtains all required signatures; ensures the research participant has sufficient time and opportunity to ask the investigator medical questions; documents the informed consent process in the source document and provides the research participant with a copy of the informed consent.Develops an effective recruitment plan (e.g., central recruitment core); recruits research participants and discuss study protocol; educates research participants about protocol expectations and meets with research participants for each visit and maintains accessibility to discuss any questions or concerns regarding the study;Oversees the development of advertising materials; participates in teleconferences and/or meetings to review study progress and conduct.Data entry responsibilities include the completion and maintenance of case report forms and reviews data against the research participant's medical record for completeness and accuracy; addressing all queries, clarifications and outstanding data queries and appropriately communicating with the sponsor and/or Contract Research Organization (CRO); completing and submitting case report forms on as close to a real time basis" as possible. Minimum Qualifications Education * Bachelor's degree or an allied health or related professional degree required, or equivalent work experience Experience * 2 years of relevant clinical research experience required * Experience in a healthcare setting preferred * Undergraduate and/or work experiences that demonstrates aptitude for research facilitation preferred Knowledge, Skills, and Abilities * Verbal and written communication skills. * Basic computer skills preferred. This position has a hiring range of $58,656 - $98,384

What We Do Care Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers. Who We Are We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations. Position OverviewThe Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. What You'll Be Working On Duties include but not limited to: Patient Coordination· Prescreen study candidates · Obtain informed consent per Care Access Research SOP . · Complete visit procedures in accordance with protocol. · Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. · Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. · Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. · Prioritize activities with specific regard to protocol timelines · Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. · Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. - Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) Documentation· Record data legibly and enter in real time on paper or e-source documents · Accurately record study medication inventory, medication dispensation, and patient compliance. · Resolve data management queries and correct source data within sponsor provided timelines · Assist regulatory personnel with completion and filing of regulatory documents. · Assist in the creation and review of source documents. Patient Recruitment· Assist with planning and creation of appropriate recruitment materials. · Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. · Actively work with recruitment team in calling and recruiting subjects Other Responsibilities- Review and assess protocol (including amendments) for clarity, logistical feasibility- Ensure that all training and study requirements are met prior to trial conduct. - Communicate clearly verbally and in writing. - Attend Investigator meetings as required. - Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) - Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. - Maintain effective relationships with study participants and other care Access Research personnel. Scope of Role · Autonomy of Role: Work is performed under general supervision· Direct Reports: No Physical Requirements · Physical demands associated with onsite duties include: -Walking-20% -Standing-20% -Sitting-20% -Lifting (up to 25lbs)-20% -Driving-20% Travel Requirements · This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives. o Type of travel required: Regional (within 100 miles) What You Bring Knowledge, Skills, and Abilities:· Ability to understand and follow institutional SOPs. · Excellent working knowledge of medical and research terminology · Excellent working knowledge of federal regulations, good clinical practices (GCP) · Ability to communicate and work effectively with a diverse team of professionals. · Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail · Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. · Critical thinker and problem solver · Friendly, outgoing personality; maintain a positive attitude under pressure. · High level of self-motivation and energy · Excellent professional writing and communication skills · Ability to work independently in a fast-paced environment with minimal supervision. Certifications, Education, and Experience:- Bachelor's Degree preferred, or equivalent combination of education, training and experience. - A minimum of 1-year prior Clinical Research Coordinator experience required - Recent phlebotomy experience required Licenses:- 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 Benefits (US Full-Time Employees Only)· 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 & InclusionWe serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to 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 value diversity and believe that unique contributions drive our success. At Care Access, every day, we are advancing medical breakthroughs. We're uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We're proud to advance these breakthroughs and work with the big players while engaging with the physicians and caring for patients. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to 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. Employment StatementCare Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.

Overview Join the HJF Team! HJF is seeking a Clinical Research Assistant to perform research and/or development in collaboration with others for projects. Will perform data collection by conducting research interviews. Provides study project and technical support to senior professional staff. The Clinical Research Assistant will recruit and screen subjects for research studies and collects baseline and follow up data from subjects. This is the first of four levels of clinical research assistants and works under the guidance and direction of senior staff. This position will be in support of the Department of Psychiatry / Center for the Study of Traumatic Stress. The Center for the Study of Traumatic Stress (CSTS) is one of the nation's oldest and most highly regarded, academic-based organizations dedicated to advancing trauma-informed knowledge, leadership and methodologies. The Center's work addresses a wide scope of trauma exposure from the consequences of combat, operations other than war, terrorism, natural and human-made disasters, and public health threats as well as risk and protective factors associated with suicidal behaviors. CSTS is a part of our nation's federal medical school, Uniformed Services University (USU), and its Department of Psychiatry. These affiliations represent the Center's history, mission and future directions as a major contributor to our country's understanding of the impact of trauma and the advancement of trauma-informed care. Learn more about the CSTS. The Department has active research programs in the Basic and Clinical Sciences and Neurosciences. In addition to intramural research projects, the Department maintains active research funded by the National Institute of Mental Health, National Institute of Drug Abuse, National Science Foundation, the Department of the Army and the Department of the Air Force. The department has ongoing collaborations with the Walter Reed Army Institute of Research, is sponsor of the Center for the Study of Traumatic Stress and provides psychiatry residency training through its affiliations with Walter Reed National Military Medical Center, National Naval Medical Center and Malcolm Grow Air Force Medical Center and the National Capital Area Graduate Medical Education Consortium. The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals. Responsibilities Performs research projects, including the collection and organization of data. Follows instructions and standard operating procedures. Independently identifies and collects reports, professional papers, and other relevant information in an organized and proactive capacity. Performs data entry in an accurate, timely, and efficient manner. Maintains clear and accurate data collection and project records, inventories, and logbooks in accordance with Good Clinical and/or Good Laboratory practices. Provides basic data analysis and interpretation. Establishes and maintains database files and progress reports for studies, projects and programs. Performs administrative duties such as: assisting in maintaining study database and files as well as scheduling study appointments; assisting in developing and submitting grants, papers and abstracts, manuscripts and presenting studies, developing protocol manuals and data collection instruments; participates in field visits. Assists with the preparation of manuscripts, reports, and presentations including editing and formatting documents. Distributes manuscripts and reports to all scientific collaborators as required. Interaction with study subjects, including screening, recruitment and data collection. May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role. Qualifications Education and Experience Bachelor's Degree. Minimum of 0-2 years experience required. Required Knowledge, Skills and Abilities Knowledge of basic computer programs Ability to follow detailed instructions Excellent written and verbal communication, organizational, and analytical skills Ability to understand and utilize scientific terminology and research theory in both oral and written communications. Ability to use measurable and verifiable information for making decisions or judgments Ability to obtain and maintain a T1/Public Trust background check. Work Environment This position will take place primarily in an office environment. Compensation The hourly pay range for this position is $18. 25-$29. 47. Actual hourly pay will be determined based on experience, education, etc. Benefits HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more. Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1. 35(c) Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Clinical Research Assistant - (250001BJ) Description The Clinical Research Assistant performs a variety of research, data and clerical duties of a routine and technical nature to support the conduct of clinical research under the direction of a senior research team member. The Research Assistant 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. In this role, the Clinical Research Assistant completes tasks including identifying eligible participants under the supervision of a senior research team member, preparing necessary documents, equipment, supplies, etc. for research visits and conducting and documenting visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies. Qualifications Minimum EducationBachelor's Degree BA/BS degree in a science, technical, health-related field or another applicablediscipline. (Required) OrMinimum Work Experience0 years Experience working in a medical or scientific research setting (Preferred) 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 guidance (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 and organizes study documents. 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 and seeks and provides input when appropriate. Participant Enrollment Adheres to the IRB-approved recruitment plan. Identifies participants that meet eligibility requirements under the supervision of a senior research team member. 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. Follows procedures for documenting participant incentive distribution. Study Management 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. Conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction. Completes accurate IRB submissions within institutional timeframes. Records participant visits in the appropriate tracking system. Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner. 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 and assists in maintaining regulatory documents per sponsor and institutional requirements. 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: Maryland-Silver SpringWork Locations: Inventa Towers 1 Inventa Place Silver Spring 20910Job: ResearchOrganization: Ctr Clinical & Community RsrchPosition Status: R (Regular) - FT - Full-TimeShift: DayWork Schedule: 9a-5pJob Posting: May 15, 2025, 1:47:27 PMFull-Time Salary Range: 42702.4 - 71156.8