Regulatory Manager- Clinical Trials Unit (CTU)

University of Tennessee, Knoxville   Memphis, TN   Full-time     Science
Posted on April 10, 2024
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Market Range: 12

Hiring Salary: $5,014.28 - $6,842.95/Monthly

JOB SUMMARY/ESSENTIAL JOB FUNCTIONS:The Regulatory Manager is an interval part of the Clinical Trials Unit (CTU) Administrative Team and CTU Set Up Team. This position monitors the status and progress of CTU setup efforts for potential new clinical trials.

DUTIES AND RESPONSIBILITIES:

  1. Oversees the development of all Institutional Review Board (IRB) and regulatory submissions for UTHSC Investigators supported by the CTU; oversees the storage of all CTU IRB and regulatory documents for all trials ensuring all required documents are prepared timely.
  2. Determines day-to-day logistics to manage workloads and prioritizes order of trial setup for IRB and regulatory needs.
  3. Collaborates with coordinators assigned to each new clinical trial to review the schedule of events required for each clinical trial; reviews patient stipend amounts, times of allocation, and processes required by Sponsor.
  4. Creates draft cost of the clinical trial for discussion/review with the PI and communicates with the Sponsor changes as directed by the PI; submits final costs for all trials to the PI for approval.
  5. Develops coordinator reports for each new trial tracking CTU services performed; monitors Cayuse submissions to check the status of CDA and CTA processing.
  6. Performs in-depth clinical review of new protocols and needs, ICF’s, CRF’s, pharmacy manuals, laboratory manuals, and required procedures to be performed and locations with the PI, Executive Director, Coordinator, and Regulatory Coordinator.
  7. Maintains database of clinical trials registered, PI’s information, submission dates, etc.; supports clincialtrail.gov new submissions and works with PI on corrections to submissions as needed.
  8. Communicates directly with the Sponsor as to the personnel needs, procedure costs, etc. for each trial; communicates with the Executive Director, Coordinators, Regulatory Coordinator, and the PI to discuss trial logistics, individual clinical needs, and time for tasks to be performed.
  9. Maintains knowledge of federal changes in the regulatory requirements for clinical trial regulatory documentation.
  10. Collaborates with CTU personnel on monthly statistical reports and data collection as needed to assist in the development of analytical plans.
  11. Performs other duties as assigned.

Qualifications :

MINIMUM REQUIREMENTS:

EDUCATION: Bachelor’s Degree. (TRANSCRIPT REQUIRED)

EXPERIENCE: Four (4) years of experience of related experience. (Previous experience in healthcare/patient/clinic or research setting with knowledge of medical terminology is preferred. Knowledge of federal regulations for clinical research to minimally include ICH, GCP’s, 21 CFR 50, 21 CFR 11, 45 CFR 46, etc. is preferred.)

KNOWLEDGE SKILLS AND ABILITIES:

· Knowledge of medical terminology and clinical trial regulatory experience.

· Strong interpersonal and communication skills.

· Ability to interact with a diverse population including research, business, and healthcare professionals.

· Ability to make and process strategic decisions.

· Excellent computer skills utilizing Excel, PowerPoint, and Microsoft Word.

· Knowledge of how research services billing processes are facilitated.

WORK SCHEDULE: This position may occasionally be required to work weekends and evenings. May occasionally require overnight travel.


University of Tennessee, Knoxville

Memphis , TN