The West Virginia University Research Corporation is seeking applications for a Regulatory Associate with the Clinical and Translational Science Institute. This position will examine, evaluate, and investigate 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.
In order to be successful in this position, the ideal candidate will:
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 work flow 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.
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;
Two (2) years of experience in regulatory aspects of industry and government sponsored clinical trials including IRB application submissions;
Or an equivalent combination of education and experience.
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 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 manage multiple projects and changing priorities is required.
Demonstrated ability to work effectively in both cross-functional teams and independently is required.
After a minimum of 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).
Internal Number: 16459
About WVU Research Corporation
West Virginia University Research Corporation is proud to be an Equal Opportunity employer. West Virginia University Research Corporation values 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.