Regulatory Affairs Manager MIND Center Clinical Research
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Job Location:
Jackson, MO - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Hello
Thank you for your interest in career opportunities with the University of Mississippi Medical Center. Please review the following instructions prior to submitting your job application:
- Provide all of your employment history education and licenses/certifications/registrations. You will be unable to modify your application after you have submitted it.
- You must meet all of the job requirements at the time of submitting the application.
- You can only apply one time to a job requisition.
- Once you start the application process you cannot save your work. Please ensure you have all required attachment(s) available to complete your application before you begin the process.
- Applications must be submitted prior to the close of the recruitment. Once recruitment has closed applications will no longer be accepted.
After you apply we will review your qualifications and contact you if your application is among the most highly qualified. Due to the large volume of applications we are unable to individually respond to all applicants. You may check the status of your application via your Candidate Profile.
Thank you
Human Resources
Important Applications Instructions:
Please complete this application in entirety by providing all of your work experience education and certifications/
license. You will be unable to edit/add/change your application once it is submitted.
Job Requisition ID:
RJob Category:
Professional and TechnicalOrganization:
MIND Center-Research AdministrationLocation/s:
Main Campus JacksonJob Title:
Regulatory Affairs Manager MIND Center Clinical ResearchJob 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
Bachelors degree in public policy business health information management or related field plus four years related experience. Masters 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 timeFLSA Designation/Job Exempt:
YesPay Class:
SalaryFTE %:
100Work Shift:
DayBenefits Eligibility:
Grant Funded:
NoJob Posting Date:
02/17/2026Job Closing Date (open until filled if no date specified):
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
UMMC educates health care professionals, conducts health sciences research, provides leading patient care and eliminates health care disparities.
