Clinical Research Assistant

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.

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.
• 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.