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Cleveland Clinic



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Health Care-Cleveland Clinic
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Hospital: Cleveland Clinic Main Campus & Family Health Centers
Department: Cardiovascular Medicine
Job Code: T26213
Pay Grade: 13
Schedule: Full Time
Shift: Days
Hours: 8am-5pm
Job Details:

Summary: Oversees the administrative functions of single and/or multi-institutional research trials. Coordinate/manage daily organization and operational issues/activities related to Phase I-IV clinical research trials. Facilitates key trial communications for academic coordination, provides clinical perspective to the design and conduct of clinical trials. Job Responsibilities: Manages and coordinates a clinical trials team (external industry team members, statisticians, database programmers and researchers) responsible for data accumulation, input and analysis. Interacts with the Finance and Legal departments to facilitate clinical trial budget, site budget and contract execution. Maintains professional relationships with Sponsor including frequent, open communication and associated documentation. Coordinates development, preparation, review and approval of research protocols, case report forms and regulatory documents for the conduct of research required by Institutional Review Board (IRB), Sponsor and FDA. Collect and review regulatory documents from sites. Communicate with institutional and central IRBs, FDA and other parties regarding protocol subject and safety issues. Organize/coordinate, attend and participate in Investigator Meetings and training programs. Develop and maintain planned communication with sites (i.e., newsletters, study progress updates, telephone communication, supportive reinforcement of Sponsor communication, etc. ). Analyzes site strengths and weaknesses related to intended protocol and selection of qualified investigators and sites. Assesses investigator and site performance. Lead initiative to improve quality and makes recommendation to discontinue site if necessary. Performs other duties as assigned

Education: Bachelor's Degree in nursing, general science, a health care discipline or computer science with programming emphasis. Demonstrated ability to work with multiple software technologies preferred. Knowledge of FDA regulations, GCPs, and internal SOPs. Knowledge of Code of Federal Regulations, ICH and GCP guidelines and their applications to clinical research trials.

Experience: Minimum three years clinical research experience as a Study Coordinator, Project Manager, Contract Research Associate or equivalent management experience in a related field. Supervisor experience desirable. Demonstrated background/ability or working with clinical studies and clinical research team members at all levels.

Licensure/Certification/Registration: Within 90 days of hire, must successfully complete certification in Human Subjects Research as required by the Responsible Conduct of Research guidelines adopted by the Cleveland Clinic. Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) certification desirable.

Physical Requirements: Requires full range of motion, manual and finger dexterity and eye-hand coordination. Requires standing and walking for extensive periods of time. Requires normal or corrected hearing and vision to normal range.

Category: Research

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