Clinical Research Assistant - PM Biorepository

Education

• Bachelor’s Degree

Technical Knowledge, Skills, and Abilities 

• Working knowledge of clinical research concepts, regulations, and Good Clinical Practice (GCP) principles. 
• Ability to interpret study protocols and apply inclusion/exclusion criteria during pre-screening. 
• Understanding of informed consent requirements and ability to explain studies to participants in a clear, professional manner. 
• Working knowledge of specimen collection, processing, labeling, storage, and shipment practices per protocol/lab manual. 
• Proficiency with electronic data capture (EDC) systems, electronic medical records (EMR), and standard office software (e.g., Word, Excel, Outlook) as applicable to the role. 
• Strong attention to detail and accuracy in source documentation review, data entry, and record maintenance Ability to prioritize tasks, manage multiple studies, and meet deadlines in a fast-paced environment.
• Effective written and verbal communication skills, including ability to coordinate with multidisciplinary teams and external study contacts. 
• Professionalism and discretion when handling confidential and protected health information (PHI); ability to follow privacy and security practices. 
• Problem-solving skills and ability to escalate issues appropriately to supervisors/PI/study team. 
• Ability to work independently with direction, and collaboratively as part of a research team.

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.