The West Virginia University Research Corporation is seeking applications for a Regulatory Associate. This position is responsible for examining, evaluating, and investigating 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. The Regulatory Association will perform 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:
Plan and write materials required for IRB submissions.
Review submission-related documents from clinical research protocols to ensure consistency with institutional compliance guidelines.
Develop and prepare informed consent documents according to institutional guidelines.
Submit study protocol amendments to the IRB.
Assist with the submission of IND safety reports and adverse event reports to the IRB.
Track all IRB submissions and communicate with IRB administration regarding new submissions and approved protocols.
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
An equivalent combination of education and experience may also be considered
Please view Equal Employment Opportunity Posters provided by OFCCP here.
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
The West Virginia University Research Corporation (WVURC) has chosen to provide a broad range of personnel services, having its employees work within the university environment, represent and support West Virginia University, while providing a distinct work package to its employees as a nonprofit corporate affiliate.
The WVURC Human Resources Office exists to support research infrastructure and... economic development opportunities at WVU by providing flexible, responsive recruitment and employment services for its sponsored activities. It is the goal of the WVURC HR Office to capitalize upon strengths, to help its workforce anticipate and meet the needs of the research community in its markets, and to value employees through effective communications, courteous, responsive, and enthusiastic service.