Job Listings

The Clinical and Translational Science Institute at West Virginia University Research Corporation is currently accepting applications for a (Hybrid) Regulatory Assoicate,

About the Opportunity

Examines, evaluates, and investigates conformity with the regulatory aspects of industry and government sponsored clinical trials and investigator initiated clinical research. This includes securing Institutional Review Board (IRB) approval and maintaining all records pertaining to IRB approval and oversight. Performs various duties, such as research, analysis and auditing in support of project IRB submissions to assure compliance.

At WVU Research Corporation, we strongly believe in work-life balance and keeping time for things we love outside our work. WVU Research Corporation offers a comprehensive benefits package with a variety of options to suit your needs:

• 13 paid holidays (staff holiday calendar)
• Paid Time off (PTO)
• 403(b) retirement savings with a fully vested 3% employee contribution match, (Employees have the option of contributing an additional 1-3% of their earnings to the plan, which is also matched by the WVURC)
• A range of health insurance and other benefits
• Dependent Education Scholarship
• WVU Perks

What You'll Do

• Plans and writes materials required for IRB submissions.
• Review submission-related documents from clinical research protocols to ensure consistency with institutional compliance guidelines.
• Develops and prepares informed consent documents according to institutional guidelines.
• Submits study protocol amendments to the IRB.
• Assists with the submission of IND safety reports and adverse event reports to the IRB.
• Tracks all IRB submissions and communicate with IRB administration regarding new submissions and approved protocols.
• Monitors, evaluates and improves regulatory submission tracking/control systems.
• Submits appropriate documents to close or suspend study protocols
• Submits and tracks regulatory documents in the clinical trials management system (CTMS) utilizing the workflow and processes
• Assists in networking opportunities and continuing education.
• Maintains knowledge of professional principles, legal and/or reporting requirements affecting area of responsibility, and adheres to industry and government standards.
• Assists and/or follows direction of management to determine the best course for customer service.
• Communicates with investigators, coordinators, and sponsors by email, telephone or in-person.
• Responds to questions regarding regulatory issues.
• Gathers anecdotal and raw data, assesses situations or program information, consider options, propose resolutions, create reports and translates data to graphical media or code.
• Assist with or complete forms for IRB submissions, etc.
• Trains users regarding electronic IRB applications.
• Contacts investigators, coordinators, and sponsors to establish rapport, understanding and/or inform, as well as to facilitate use of the organization's programs, services, and/or products.
• Adjusts, refers for and/or investigates complaints.
• Testifies before auditors and administrators.

• Bachelor's degree in an allied health discipline or related field.
• A minimum of two (2) years of experience in the following:
  • Regulatory aspects of industry and government sponsored clinical trials including IRB application submissions
• Any equivalent combination of related education and/or experience will be considered.
• All qualifications must be met by the time of employment.

Knowledge, Skills and Abilities

• Working knowledge of regulatory aspects of industry and government sponsored clinical trials including IRB regulations.
• Skilled at problem solving.
• Excellent teamwork skills.
• Basic work processing skills and understanding and the ability to handle stress and work under pressure.
• Skilled at using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
• Strong time management skills.
• Computer proficiency, including Microsoft Office.
• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
• Ability to manage multiple projects and changing priorities is required.
• Demonstrated ability to work effectively in both cross-functional teams and independently is required.

Requirements

• After a minimum of two (2) years of employment, it will be expected that the incumbent obtain certification as a Research Professional through the Society Clinical Research Associates (SoCRA) or the Association of Clinical Research Professionals (ACRP).

The WVURC was created as a not-for-profit corporation in 1985 to support research (R1) at West Virginia University. We provide evaluation, development, patenting, management, and marketing services for inventions of the faculty, staff and students of the University.

The WVURC receives and administers funds awarded by external agencies for research and other activities and is responsible for helping protect intellectual property through patents, copyrights and licensing agreements for start-up companies based on University research.

West Virginia University Research Corporation is proud to be an Equal Opportunity employer. We value diversity among its employees and invites applications from all qualified applicants regardless of race, ethnicity, color, religion, gender identity, sexual orientation, age, nationality, genetics, disability, or Veteran status.