Apply now Job no: 533242
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Categories: Grant or Research Administration, Health Care Administration/Support
Department: 29050800 - MD-INFECTIOUS DISEASES
Classification Title: MGR, Clinical Research
Job Description: The Department of Medicine, Division of Infectious Diseases and Global Medicine is seeking a full-time MGR, Clinical Research. This position is located in the Department of Medicine, Division of Infectious Diseases and Global Medicine. Under the direction of the Division Administrator and Division Chief, this position will be responsible for all divisional regulatory tasks and clinical research management. This position will provide management and direction for the division’s clinical and human subject research portfolio.
Essential Functions:
- REGULATORY MANAGEMENT
• Oversee the preparation and collation of all documentation required to support clinical trial applications, ensuring compliance with regulatory standards.
• Lead the preparation of IRB applications and maintain regulatory and IRB approvals throughout the project lifecycle.
• Direct the development and review of briefing documents to facilitate effective meetings with regulatory bodies.
• Coordinate the preparation and submission of annual reports, ensuring timely and accurate documentation.
• Manage updates to documentation in response to IRB or Regulatory comments and queries, ensuring all regulatory documents are current and compliant.
• Implement and maintain a comprehensive document filing system for easy access and historical tracking of documentation across projects.
• Supervise the renewal, re-registration, and submission of variations, amendments, and notifications, maintaining up-to-date regulatory status reports for all active projects. - CLINICAL RESEARCH MANAGEMENT
• Support the Chief, Faculty, and Division Administrator in advancing the research missions of the Division of Infectious Diseases and Global Medicine.
• Collaborate closely with clinical research coordinators, the grants team, the Division Administrator, and the Office of Clinical Research to oversee the division’s clinical research activities.
• Manage pre- and post-award financials, including invoicing sponsors for services and reconciling electronic study payments via the university’s clinical research system.
• Assist the Division Administrator with ad hoc assignments to support basic science research faculty and laboratories.
• Review clinical research protocols to assess feasibility and serve as a resource, providing guidance, to study coordinators with planning and implementing strategies for successful participant recruitment.
• Provide training and support to divisional clinical research coordinators and serve as a clinical research coordinator for select clinical trials. - ADDITIONAL RESPONSIBILITIES
• Step in as a study coordinator as needed to support ongoing clinical trials and ensure continuity of research activities.
• Prepare annual budget information to include in the division’s annual budget.
• Manage the division’s clinical trials operating account, including preparing annual projections for daily management and future staffing purposes.
Salary: $70,000 - $92,200
Minimum Requirements: Master’s degree in appropriate area of specialization; or a bachelor’s degree in appropriate areas of specialization and two years of experience.
Preferred Qualifications: Familiarity with regulatory documentation and clinical trials.
Strong communication skills, good organization, detail-oriented, familiarity with medical environment.
Special Instructions to Applicants: In order to be considered, you must upload your resume.
This position is time limited.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required: Yes
Advertised: 23 Oct 2024 Eastern Daylight Time
Applications close: 03 Nov 2024 Eastern Standard Time
The University is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.
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