Clinical Research Coordinator

111 Michigan Avenue Northwest Washington, DC 20010 Kids Are Our Everything. Department 10572 Clinical Research Ops Pay Range $51,584.00 - $85,987.20 The Clinical Research Coordinator participates in or leads day-to-day operations of clinical research studies conducted by a principal investigator. The Research Coordinator performs a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data. The Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. This position may direct the work of junior staff, train personnel and direct the work of a Clinical Research Assistant as assigned. Minimum Education B.A./B.S. degree in a science, technical, health-related field or other applicable discipline (Required) Minimum Work Experience 1 year of applicable work, research or internship experience (e.g. research assistant, data manager, clinician or other interaction with a research population). (Required) Functional Accountabilities Responsible Conduct of Research Consistently demonstrates adherence to the standards for the responsible conduct of research. Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator. Stays informed of and adheres to institutional policies and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and 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. Reviews current literature to obtain information relevant to clinical research program, as directed. 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. Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center. Participant Enrollment Employs strategies to recruit and retain research participants, while adhering to the IRB-approved recruitment plan. Screens subjects for eligibility per the protocol and institutional policies. Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies. Independently coordinates, 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. 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 documentation of study payments and participation incentives. 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. Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies. Collects, prepares, processes, ships and maintains accurate inventory of research specimens, and trains others in performing these tasks. Suggests improvements to specimen handling processes, when needed. Authors study documents, including informed consents, protocol-specific source documents and IRB contingency responses. Registers and 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. Coordinates, prepares for and responds to routine oversight body visits and audits. Performs query resolution and assists with addressing and correcting audit findings. Data Collection Collects data from patient medical records, interviews, questionnaires, diagnostic tests and other sources. 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. Benefits That Support You: Comprehensive health coverage, including medical, prescription, infertility, and transgender health services. Generous paid time off, including vacation accrual from day one, sick leave, holidays, and a personal day. Financial wellness support, including a 401(k) plan and healthcare and dependent care spending accounts. Employer-paid life, AD&D, and long-term disability coverage, with optional supplemental plans. Additional perks, including tuition assistance, fitness resources, employee assistance, commuter benefits, and more. Why Join Us: Nationally Recognized Excellence Consistently ranked among the Top 10 Childrens Hospitals in the nation by U.S. News & World Report. Leading Pediatric Care One of the largest and most comprehensive childrens hospitals in the country, offering nationally ranked specialties and cutting-edge treatments. Innovation & Research A premier academic medical center with a strong commitment to pediatric research, education, and advancing the future of child health. Mission-Driven Culture Dedicated to providing family-centered care while fostering a collaborative, supportive environment for clinical teams. The disclosed salary range includes the minimum and maximum rates within which Childrens National believes an individuals base pay rate will fall for this position. It is not typical for an individual to be hired at or near the maximum of the pay range. The exact pay rate for this position will be based on a variety of factors in alignment with the Childrens National compensation philosophy. These factors are legitimate and non-discriminatory including, but not limited to, the current market conditions; organizational needs; the individuals combination of prior work experience, level of education, knowledge, skills, and other qualifications. Childrens National is committed to providing a fair and competitive total rewards package to each of our employees. This base salary range does not include our comprehensive benefits package or any additional compensation for which this position may be eligible. Childrens National Hospital is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender, identity, or other characteristics protected by law. The Know Your Rights poster is available here: and the pay transparency policy is available here: Know Your RightsPay Transparency Nondiscrimination Poster. Please note that it is the policy of Children's National Hospital to ensure a drug-free work environment: a workplace free from the illegal use, possession or distribution of controlled substances (as defined in the Controlled Substances Act), or the misuse of legal substances, by all staff (management, employees and contractors). Though recreational and medical marijuana are now legal in the District of Columbia, Children's National and its affiliates maintain the right, in accordance with our policy, to enforce a drug-free workplace, including prohibiting recreational or prescribed marijuana. Why Children's Benefits Nursing Careers Introduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match. Recruitment Fraud Notice - As fraudulent recruitment activities by individuals or organizations falsely claiming to represent hospitals are on the rise. 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