JOB SUMMARY

This position provides independent coordination of multiple, complex clinical research studies in order to ensure the efficiency and accuracy of clinical studies through all stages as the study progresses and shows vigilance in participant safety, protocol compliance, and data quality. This position may also provide guidance to other clinical research support personnel. This job evaluates, initiates and maintains all activities related to the conduct of clinical trials in assigned area(s) of responsibility. Communicates effectively with external funding agencies, sponsors regarding study activity, as well as affiliated departments, departmental staff and patients to assure the understanding of the requirements of conducting and participating in clinical trials. Participates, as needed, in the regulatory processes as they relate to the evaluation, initiation, maintenance, closure of studies, internal and external audits of clinical trials, and other research activity.

• Coordinates and oversees subject activity as it relates to the conduct of research and clinical trials.
• Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care.
• Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines and regulatory requirements.
• Maintains competency in requirements and regulations associated with the conduct of clinical trials and other related research activity.
• Supports department, division, and institutional goals.

Other related duties as required. The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time. Remains knowledgeable on current federal, state and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations and standards.

Follows regulatory requirements, established policies, procedures and professional guidelines in planning, implementing, documenting and reporting study requirements. Responsible for maintaining study files, logs, data entry and management of databases for clinical research studies. Participates as needed in the regulatory document submissions as required by the sponsor of the trial, regulatory agencies, and TGH research policy. The coordinator is responsible for performing job duties in accordance with the mission, vision and values of the Office of Clinical Research and Tampa General Hospital.

• Bachelor's degree in Science or related field required.
• One to two years relevant experience in a clinical setting required and clinical research experience preferred.
• Experience working independently, organizing work, and setting priorities.
• Basic Cardiopulmonary Life Support certification is required within 30 days of hire.
• Phlebotomy experience is preferred or completion of course works within three months of accepting the position.
• CCRC, CCRP or related certification required or must be obtained within 1 year of employment.
• Must have computer skills and dexterity required for data entry and retrieval of patient information.
• Must be proficient with Windows-style applications and keyboard.
• Effective verbal and written communication skills and the ability to present information clearly and professionally to varying levels of individuals throughout the patient care process.