Clinical Research Assistant - PM Biorepository

Tampa General Hospital•Tampa, FL

About The Position

The Clinical Research Assistant supports multiple clinical research projects under the supervision of Clinical Research Supervisors and Clinical Research Managers. The role helps coordinate day-to-day study operations, participant screening and enrollment, research visits, specimen handling, documentation, and data entry while working with research staff and departments where research is conducted. The assistant pre-screens potential participants against study eligibility criteria, explains studies, and obtains and documents informed consent for assigned non-interventional registry or observational studies and select minimal-risk device studies. The position also assists with enrollment and randomization, coordinates study-related tasks and procedures, and collects and processes specimens according to study protocols and laboratory manuals. Accurate records, timely communication, training, and support for monitoring, auditing, and close-out activities are also part of the role.

Requirements

Bachelor’s degree.
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 clearly and professionally.
Working knowledge of specimen collection, processing, labeling, storage, and shipment practices per protocol or laboratory manual.
Proficiency with electronic data capture (EDC) systems, electronic medical records (EMR), and standard office software such as Word, Excel, and 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 the ability to coordinate with multidisciplinary teams and external study contacts.
Professionalism and discretion when handling confidential and protected health information (PHI), and ability to follow privacy and security practices.
Problem-solving skills and ability to escalate issues appropriately to supervisors, the PI, or the study team.
Ability to work independently with direction and collaboratively as part of a research team.

Responsibilities

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, and 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 and 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 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 promptly to the supervisor, PI, or study coordinator; assist with issue resolution and follow-up.
Participate in required training, including GCP, human subjects protections, and 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.