Clinical Research Coordinator

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.