Job Description

The Clinical Research Coordinator 2 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 staff and support personnel. The Clinical Research Coordinator 2 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. 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. Full time presence in the office is required.

Qualifications

Education

Bachelor's degree in Science or Healthcare related field

Certification

Good Clinical Practice certification or completion within 3 months of hire

Basic Cardiopulmonary Life Support or completion within 6 months of hire

IATA Dangerous Goods or equivalent training

Work Experience

A minimum of three (3) years of clinical research experience, including at least 2 years specifically focused on specialty clinical research. Strong working knowledge of applicable regulations (i.e. FDA, NIH, OHRP, etc.) and demonstrated ability to navigate ambiguous areas. Phlebotomy experience or completion of course work within six months of accepting the position. An equivalent combination of education and years of experience or realized competencies.

Technical Knowledge, Skills, and Abilities
• Intimate knowledge of advance and complex experimental design, statistics, computerized database
• Demonstrated ability to understand and implement scientific protocol
• Strong working knowledge of applicable regulations (i.e. FDA, NIH, OHRP, etc.) and demonstrated ability to navigate ambiguous area
• Demonstrated clinical competency with patient related measurements and with a high degree of accuracy with respect to documentation and data collection
• Ability to work with spreadsheets (such as Excel), familiarity with databases (ex: Medidata RAVE, iMedra, Velos, etc) and querying.
• Excellent interpersonal skills are required for working with the study participants and working as a member of a highly integrated multi-disciplinary team
• Exceptional attention to detail and excellent technical problem-solving skills.
• Excellent organizational skills and ability to prioritize and be flexible to manage multiple tasks.
• Excellent oral and written communication skills.
• Intermediate proficiency in Microsoft Office.
• Ability to travel between clinical sites, whenever required

Job Tags

Full time, Work experience placement, Work at office, Local area, Flexible hours,

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