Clinical Research Coordinator

Clinical Research Coordinator (2600013Y)

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 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.

• Works under supervision of PI to manage various databases for clinical research studies and patient services grants.
• Responsible for research activities related to a variety of research studies and clinical trials.
• Recruit and consent participants in an outpatient clinical setting on a weekly basis.
• Liaise directly with team members, PI, CNH IRB, and study-related personnel to monitor program implementation and evaluation.
• Prepare documents related to IRB and audits.
• Identify and collect data from youth with HIV or engaged in HIV prevention services at CNH for study purposes.
• Compile source data, verify accuracy, and input data.
• Support data initiatives for other projects as needed, identifying opportunities for improving data management.
• Maintain knowledge and comprehension of assigned research protocols, including study procedures, timelines, and eligibility.
• Accurately create, complete, maintain, and organize study documents.
• Account for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s), and participation incentives.
• Use and account for research funds and resources at performance level, including reconciling research subject billing if assigned.
• Review current literature to obtain information relevant to the clinical research program, as directed.
• Attend study meetings, which could include overnight travel, as requested by principal investigator.
• Work well with other members of the research team and provide input when appropriate.
• Serve as an effective liaison between the investigators, sponsors, hospital departments involved with research studies, and the Clinical Research Center.
• Employ strategies to recruit and retain research participants while adhering to the IRB‑approved recruitment plan.
• Screen subjects for eligibility per the protocol and institutional policies.
• Communicate effectively and provide information to a diverse, vulnerable subject population in accordance with institutional policies.
• Independently coordinate, conduct, and document 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.
• Interact with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details, and to assess participation interest.
• Engage participants/LARs in the informed consent process according to institutional policies.
• Follow procedures for documentation of study payments and participation incentives.
• Collect, prepare, process, ship, and maintain accurate inventory of research specimens, and train others in performing these tasks.
• Suggest improvements to specimen handling processes when needed.
• Author study documents, including informed consents, protocol‑specific source documents, and IRB contingency responses.
• Register and record participant visits in the appropriate tracking system.
• Anticipate study needs and subject caseload to meet organizational objectives and deadlines in a timely manner.
• Coordinate, prepare for, and respond to routine oversight body visits and audits.
• Perform query resolution and assist with addressing and correcting audit findings.
• Collect data from patient medical records, interviews, questionnaires, diagnostic tests and other sources.
• Ensure data is collected as required by protocol and in accordance with research data…