Compliance Specialist

5 days ago


Morgantown, West Virginia, United States WEST VIRGINIA UNIVERSITY RESEARCH CORPORATION Full time
About the Opportunity

West Virginia University Research Corporation is currently seeking a highly skilled Compliance Specialist to join our team at the WVU Cancer Institute/Clinical Research Unit. As a key member of our Compliance Team, you will play a critical role in ensuring compliance with established health authority regulations and collaborating with clinical research teams to implement remedial action plans and processes.

The Compliance Specialist will be responsible for conducting periodic monitoring, reviewing study-related regulatory documentation, and verifying the validity of research results. Additionally, you will lead collaborations with clinical research teams to identify and resolve non-compliance issues, generate monitoring reports, and participate in regulatory agency and Sponsor audits.

This is an exciting opportunity to join a dynamic team and contribute to the success of our clinical research programs. If you are a detail-oriented, organized, and highly motivated individual with a passion for regulatory compliance, we encourage you to apply.

Key Responsibilities
  • Conduct periodic monitoring and review of study-related regulatory documentation to ensure compliance with established health authority regulations.
  • Verify the validity of research results and ensure timely, accurate, and complete source data and Case Report Form documentation.
  • Lead collaborations with clinical research teams to identify and resolve non-compliance issues and implement corrective and preventive action plans.
  • Generate monitoring reports and participate in regulatory agency and Sponsor audits.
  • Support the clinical research team by ensuring they have adequate training and processes for the responsible conduct of research.
Requirements
  • Bachelor's degree in an appropriate area of specialization or an equivalent combination of education and experience.
  • A minimum of three (3) years of research coordinator and/or project management experience in clinical research.
  • Working knowledge of regulatory aspects of pharmaceutical and medical devices industries and government-sponsored clinical research studies.
  • Experience in clinical research, including proficiency with databases and/or patient data.
  • Strong interpersonal skills and ability to work with a broad range of people, including investigators, physicians, clinic and hospital staff, sponsors, and partners at other institutions.
About West Virginia University Research Corporation

West Virginia University Research Corporation is a not-for-profit corporation created to support research at West Virginia University. We provide evaluation, development, patenting, management, and marketing services for inventions of the faculty, staff, and students of the University.

We are committed to creating an inclusive, engaged, and dynamic environment and welcome candidates who can contribute a range of ideas, approaches, and experiences. West Virginia University Research Corporation is proud to be an Equal Opportunity employer and values diversity among its employees.



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