Responsible for the overall leadership and direction of all clinical research operations including but not limited to fiscal management, study and site operations, regulatory processes and patient recruitment. The Lead Clinical Research Coordinator is responsible for developing growth strategies, and managing and/or coordinating clinical studies.
Essential Job Functions (the required results/outcomes of the job):
Promote business growth with PENTA Investigators and increase visibility within the Pharmaceutical and Medical Device Industry. Ensure subject safety across all trials.
Assess clinical trials in terms of study's impact on site resources, labor cost, cost by procedure and practice suitability. Complete site feasibilities, facilitate sponsor pre-site visits and secure clinical trials for the PENTA research department.
Coordinate Phase I through Phase IV clinical device & pharmaceutical trials. Duties include obtaining suitable patients who meet all admission criteria, assisting with patient education, adhering to the study protocol and maintaining proper documentation according to the protocol and regulatory requirements. Documenting laboratory data and adverse reaction, correcting discrepancies, anticipating possible problems and resolutions, maintain communication with the monitor from the sponsoring company, and performing technical requirements of the protocol which included phlebotomy.
Develop and implement the marketing plan for PENTA research as well as the recruitment plan for each enrolling study. Monitor subject accrual rates and implement action plans for accrual issues
Complete all IRB documents to obtain regulatory approval. Manage annual reports to the IRB. Document protocol deviations and report to the IRB as required.
Develop the budget for each study and perform negotiations with study sponsors. Invoice sponsors as required and prepare the allocation spreadsheet for each check. Manage research expenses. Review and approve study contracts.
Develop and revise the PENTA research SOP's. Ensure research staff adherence to SOP's and all federal requirements.
Train and supervise support staff ensuring adherence to protocol and regulatory requirements.
Manage special projects and other research initiatives as assigned.
* Relevant Bachelor's degree (Health Administration, Nursing or Business) or equivalent combination of experience and education/certification (CCRC).
* Minimum of five (5) years pharmaceutical research experience including previous supervisory experience.
Internal Number: LCRC-002
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