Regulatory Associate - Department of Ophthalmology

About the role

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

Responsibilities

• Completes all regulatory activities associated with active industry and cooperative group sponsored clinical studies.
• Starts up tasks of sponsored clinical studies.
• Plans and writes materials required for IRB submissions.
• Sets and submits new protocols to WVU IRB for local review and acknowledgment.
• Reviews and reconciles regulatory files with sponsor monitors.
• Prepares and submits IRB continuing reviews and amendment reviews.
• Updates protocol specific documents including FDA Form 1572, Financial Disclosure Forms, Delegation Logs, and Training Logs as needed.
• Notifies appropriate institutional officials of external audits by FDA and sponsors.
• Reviews and reconciles regulatory files with sponsor monitors.
• Maintains professional and prompt communications with investigators, coordinators, and sponsors as required.
• Responds to questions regarding regulatory issues, including queries from internal quality review.
• Maintains knowledge of professional principles, legal and/or reporting requirements affecting area of responsibility, and adheres to industry and government standards.
• Participates in networking opportunities, and continuing education.
• Manages multiple projects and changing priorities.
• Works effectively in both cross-functional teams and independently.
• Handles confidential information with discretion.

Requirements

• A Bachelor's degree in an allied health discipline or related field.
• A minimum of two (2) years of experience in a clinical setting and/or experience working in clinical trials.
• Master's degree is preferred.
• 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).