Clinical Research Assistant - PM Biorepository

The Clinical Research Assistant supports multiple clinical research projects under the supervision of the Clinical Research Supervisors and Clinical Research Managers. Key duties include pre-screening potential participants against protocol eligibility criteria; obtaining and documenting informed consent for non-interventional registry/observational studies and select minimal-risk device studies; assisting with subject enrollment, randomization, and coordination of research visits; reviewing study lab manuals and collecting/processing specimens per protocol; performing accurate data entry from source documents to paper/electronic case report forms (including redaction as requested); and serving as a liaison between research staff and departments where research is conducted, along with other assigned tasks.

Essential Functions

• Support day-to-day operations of multiple clinical research studies under the direction of the Clinical Research Supervisors/Manager and study team.
• Pre-screen potential participants by reviewing available information and applying protocol-specific eligibility criteria.
• Approach potential participants as directed; explain study purpose and procedures; obtain and document informed consent for eligible, assigned studies in accordance with IRB and institutional requirements.
• Assist with subject enrollment, randomization (as applicable), and scheduling/coordination of research tasks and study-related procedures.
• Coordinate with clinical areas and ancillary departments where research activities occur to facilitate study workflows.
• Collect, process, label, store, and/or ship biological specimens according to the protocol and laboratory manual; maintain accurate specimen logs and chain-of-custody documentation as required.
• Maintain accurate and timely study documentation, including source documents and screening/enrollment logs, as assigned.
• Enter study data into paper or electronic case report forms/EDC systems; perform document redaction and file preparation as requested.
• Communicate study updates, issues, and participant-related concerns to the supervisor/PI/study coordinator promptly; assist with issue resolution and follow-up.
• Participate in required training (e.g., GCP, human subjects protections, safety/privacy) and comply with institutional policies and procedures.
• Prepare for and support study monitoring, auditing, and close-out activities as assigned.
• Perform other related duties as assigned to support research program needs.