Regulatory Affairs Manager _ MIND Center Clinical Research

University of Mississippi Medical Center • Jackson, MS

2d • Onsite

About The Position

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.

Requirements

• Bachelor's degree in public policy, business, health information management, or related field plus four years related experience.
• 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.

Nice To Haves

• Master's degree and Certified Clinical Research Professional (CCRP) or Certified Research Administrator (CRA) preferred.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees