Clinical Research Associate
Clinical Research Associate
Dept Number/Name: 0-6001-005 / HSC Office of Research
College Division: USF Health-Office of Research
Salary Plan: Administrative
Job Code/Title: 4728 / Clinical Research Associate
Hiring Salary/Salary Range: $45,000 - $61,000
Position Number: 00049662
ORGANIZATIONAL SUMMARY:
The Clinical Research Coordinator will coordinate, conduct and evaluate research related activity for clinical research projects as assigned.
The primary purpose of this position is to oversee the regulatory component of the clinical trials as well as screening, enrollment and retention of study participants, to coordinate study visits, ensure quality of data collected throughout the research study, and implement the procedures and activities of the assigned study protocols, according to all applicable regulations and regulatory compliance, under the direction of the Principal Investigator and the Director of Clinical Research.
POSITION SUMMARY:
The Regulatory Clinical Research Coordinator will handle the start-up and maintenance regulatory process of the clinical trial studies manage by the OCR.
The primary purpose of this position is to oversee the regulatory component of the clinical trials activities of the assigned study protocols, according to all applicable regulations and regulatory compliance, under the direction of the Principal Investigator and the Director of Clinical Research.
RESPONSIBILITIES:
Manage study Master Investigator File in the Florence platform. Fulfill required certification or registration processes when assigned to research projects where study visit activity occurs at Affiliate Institutions.
Manage new study start up regulatory documents, including Form FDA 1572-Statement of Investigator, curriculum vitaes, financial disclosures, etc.
Prepare, process and submit regulatory documents and applications, including consent forms, to the Institutional Review Board(s) and other research review boards and committees as applicable and according to regulatory and institutional requirements. Communicate with PI and site staff, project sponsors and CROs, and review committees to ensure accuracy of regulatory documents and submissions. Track study approvals and expirations to ensure uninterrupted project approvals. Maintain regulatory files for assigned protocols. Assure all reporting requirements are met per regulatory and institutional policies and procedures.
Assist in the day to day operations of the Clinical Research Center (CRC) including the coordination of clinical research study activities amongst all users of this shared resource. Assist with the development and dissemination of policies, procedures and site SOPs for the CRC. Ensure quality assurance of research activities conducted in the CRC. Serve as a CRC liaison with investigators, study staff, USF Health Care and research volunteers as we as research sponsors and Clinical Research Organizations (CROs).
Performs other duties as assigned.
POSITION QUALIFICATIONS:
MINIMUM:
This position requires a Bachelor's degree in a field directly related to the program responsibilities and one year of professional experience; or Master's degree in an area of specialization appropriate for the program.
PREFERRED:
Bachelor's degree in a field directly related to the program responsibilities and one year of professional experience; or 5+ years of Clinical Trials Research experience. Human subjects protections training, knowledge of the Code of Federal Regulations, GCP (Global Good Clinical Practice)
USF Health
Information for Applicants
This position is subject to a Level 1 criminal background check.
Job Opening Number: 31223
Original Posting Date: 06/27/2022 - Previous applicants need not re-apply
Posting End Date: Open till filled
How To Apply
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Apply online by completing the required information and attaching your cover letter and resume. Please include your experience as it relates to the qualifications stated above. YOUR COVER LETTER AND RESUME, PLUS ANY OTHER REQUESTED MATERIAL, MUST BE IN ONE ATTACHMENT. Only online applications are accepted for this position.
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Equal Employment Opportunity
USF is an equal opportunity, equal access academic institution that embraces diversity in the workplace. The University of South Florida does not discriminate on the basis of sex and prohibits sexual harassment. Any person may report sex discrimination, including sexual harassment (whether or not the person reporting is the person alleged to be the victim of conduct that could constitute sex discrimination or sexual harassment), in person, by mail, by telephone, or by electronic mail, using the contact information listed for the Title IX Coordinator. Reports may be made at any time either online or directly to the University's Title IX Coordinator.
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About USF
The University of South Florida is a high-impact global research university dedicated to student success. Over the past 10 years, no other public university in the country has risen faster in U.S. News & World Report's national university rankings than USF. Serving more than 50,000 students on campuses in Tampa, St. Petersburg and Sarasota-Manatee, USF is designated as a Preeminent State Research University by the Florida Board of Governors, placing it in the most elite category among the state's 12 public universities. USF is a member of the American Athletic Conference.
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