Biorepository Research Coordinator 1 - PM Biorepository

Tampa General Hospital•Tampa, FL

About The Position

The Biorepository Research Coordinator I supports the ongoing operations of the Tampa General Hospital/USF Health Precision Medicine Biorepository, which generates, organizes, and delivers bioanalytes and abstracted data for clinical and translational research programs at Tampa General Hospital and its Cancer Institute. Under general supervision and in accordance with established policies, procedures, and professional guidelines, the coordinator conducts study coordination, including screening potential participants for protocol eligibility, presenting studies, obtaining and documenting informed consent, and enrolling subjects. The role also involves collecting, preparing, preserving, and managing biological specimens for research, as well as maintaining accurate and timely source documents, collecting and entering data, reporting, and responding to sponsor queries. With direction and oversight, the coordinator supports daily biorepository activities and assists with low-complexity, mild-patient-acuity cases at a moderate workload. The position works closely with TGH operating room staff and faculty and staff in Pathology, Surgery, Anesthesiology, Nursing, and the TGH Cancer Institute to support productivity and assigned responsibilities. The coordinator handles participant registration and study records; collects, processes, preserves, stores, transports, and distributes specimens and associated metadata; abstracts clinical and demographic data in a HIPAA-compliant manner; and transcribes source data to paper or electronic case report forms. Specimens and bioanalytes may include serum, plasma, peripheral blood mononuclear cells, cell pellets, cultures, genomic DNA, total RNA, protein, fresh and flash-frozen tissue, FFPE, and slides. The role also includes maintaining required training and certifications, representing the biorepository in interactions with outside sponsors, and adhering to department policies and professional standards. Duties may be added or amended and the listed functions are not exhaustive.

Requirements

Bachelor’s degree.
At least one year of patient-facing responsibilities or one year of experience working with and processing biological samples.
Good Clinical Practice (GCP) certification upon hire or within three months of hire.
IATA Shipment of Biologic Specimens, Transportation of Dangerous Goods, or equivalent training upon hire or within three months of hire.
Familiarity with electronic medical records (EPIC) and medical terminology.
Basic computer skills and knowledge of Microsoft Office products.
Excellent interpersonal skills for working with study participants and as part of a multidisciplinary team.
Strong attention to detail and technical problem-solving skills.
Strong organizational skills, with the ability to prioritize and flexibly manage multiple tasks.
Excellent oral and written communication skills.
Ability to understand and implement scientific protocols as directed.
Ability to work with spreadsheets such as Excel; familiarity with databases such as Medidata RAVE, iMedra, or Velos, and with querying.
Ability to travel between clinical or institutional sites when required to transport specimens or consent patients.

Responsibilities

Pre-screen potential subjects for assigned studies using written eligibility criteria.
Obtain and document written informed consent in accordance with institutional requirements and regulations.
Register subjects in required systems, including CTMS, Velos, EHR, and EDC, and maintain relevant logs such as adverse event, deviation, and participant logs.
Collect, process, and preserve biological specimens from subjects undergoing clinically indicated procedures or surgery, following standard operating procedures and quality metrics.
Review study-specific laboratory manuals and obtain and process laboratory specimens as required by research protocols.
Abstract, organize, and transmit disease-specific clinical data and demographics in a HIPAA-compliant manner.
Transcribe data from source documents to paper or electronic case report forms, redact source documents as requested, and respond to queries in a timely manner.
Prepare, preserve, and store bioanalytes, including serum, plasma, peripheral blood mononuclear cells, cell pellets, cultures, genomic DNA, total RNA, protein, fresh and flash-frozen tissue, FFPE, and slides.
Organize, store, transport, and distribute specimens and associated metadata requested by investigators.
Execute day-to-day biorepository operations in a timely manner to meet TGH Cancer Institute programmatic goals.
Maintain accurate and consistent documentation for assigned clinical studies.
Serve as a liaison and representative of Cancer Institute Biorepository Research with outside sponsors, including the National Cancer Institute, academic cancer centers, and universities.
Maintain current certifications and training in human subjects research, Good Clinical Practice, HIPAA, shipment of biological specimens (IATA), and other topics as required.
Promote a positive image of the department and organization through professional conduct, appearance, and communication.
Follow established department policies, procedures, and standards.