Regulatory Affairs Manager-Jackson Heart Study-Jackson Medical Mall
The University of Mississippi Medical Center
Jackson, Mississippi
regulatory
manager
medical
research
regulatory
management
regulations
education
procedures
assessment
certifications
project management
medical
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July 13, 2023
The University of Mississippi Medical Center
Jackson, Mississippi
FULL_TIME
Welcome Applicant!
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Thank you,
Human Resources
Important Applications Instructions:
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Job Requisition ID:
R00020137
Job Category:
Research (Non-Faculty Only)
Organization:
SOM-Medicine-JHS-Project Management
Location/s:
Jackson Medical Mall
Job Title:
Regulatory Affairs Manager-Jackson Heart Study-Jackson Medical Mall
Job Summary:
To review and provide training and guidance on all regulatory documentation and requirements, including those of local and external IRBs, sponsors, and other agencies, in a central research service office within the Institution. To ensure that all applicable regulations, policies, and procedures are followed as mandated by UMMC, the FDA, and ICH.
Education & Experience
Bachelor's degree in public policy, business, health information management, or related field plus four years related experience. Master's degree and Certified Clinical Research Professional (CCRP) or Certified Research Administrator (CRA) preferred.
CERTIFICATIONS, LICENSES OR REGISTRATION REQUIRED: NA
Knowledge, Skills & Abilities
Analytical skills and the ability to interpret regulatory requirements. Comprehensive working knowledge of local, state, and federal regulations as pertaining to GCP, FDA, ICH guidelines and HIPAA requirements. Knowledge of project management principles. Interpersonal skills to interact with a wide range of constituencies. Detail oriented, outstanding organizational skills, and the ability to meet deadlines. Skills in the use of personal computers and related software applications.
RESPONSIBILITIES
Review and revise regulatory documents for local and external IRB review.
Complete regulatory assessments as required to support projects and provide direction to principal investigators and research staff.
Develop and provide training on best practices to further first-time-quality in submissions to local and external IRBs.
Oversee the IRB submission and approval process for assigned clinical trials in order to facilitate efficient site activation.
Develop and maintain knowledge and understanding of existing and emerging legislation, regulations, standards, processes and procedures.
Educates appropriate units on any changes in standards and regulations related to clinical trials.
Assists with the development of standard operating procedures or other documents as needed.
The duties listed are general in nature and are examples of the duties and responsibilities performed and are not meant to be construed as exclusive or all-inclusive. Management retains the right to add or change duties at any time.
Physical and Environmental Demands
Requires occasional bending, occasional lifting and carrying up to 50 pounds, occasional crouching/stooping, occasional driving, occasional kneeling, occasional pushing/pulling, occasional reaching, frequent sitting, frequent standing, occasional twisting, and frequent walking. (occasional-up to 20%, frequent-from 21% to 50%, constant-51% or more)
Time Type:
Full time
FLSA Designation/Job Exempt:
Yes
Pay Class:
Salary
FTE %:
100
Work Shift:
Day
Benefits Eligibility:
Benefits Eligible
Job Posting Date:
03/14/2022
Job Closing Date (open until filled if no date specified):
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