Regulatory Affairs Manager _ MIND Center Clinical Research jobs in United States
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University of Mississippi Medical Center · 20 hours ago

Regulatory Affairs Manager _ MIND Center Clinical Research

University of Mississippi Medical Center is seeking a Regulatory Affairs Manager for the MIND Center Clinical Research. The role involves reviewing and providing training on regulatory documentation and ensuring compliance with applicable regulations, policies, and procedures.

EducationHealth CareMedical

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

Qualification

Regulatory documentationGCP guidelinesFDA regulationsICH guidelinesHIPAA requirementsProject managementAnalytical skillsSoftware applicationsInterpersonal skillsOrganizational skills

Required

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

Preferred

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

Company

University of Mississippi Medical Center

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University of Mississippi Medical Center is a school in Jackson. It is a sub-organization of University of Mississippi.

Funding

Current Stage
Late Stage
Total Funding
$37M
2013-08-22Debt Financing· $37M

Leadership Team

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Britt Crewse
Chief Executive Officer - Adult Hospitals
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Dodie McElmurray
Chief Executive Officer- Community Hospitals
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