Regulatory Compliance Officer - Clinical Trials Office

Overview

The organization is seeking a Regulatory Compliance Officer to help ensure research protocols managed by the Clinical Trials Office (CTO) comply with university, state, and federal regulations. This role supports timely submission of required documentation for agency review.

Responsibilities

• Collaborate with investigators during study development to ensure appropriate regulatory safeguards are included
• Conduct detailed reviews of assigned protocols and informed consent forms prior to IRB review
• Ensure timely submission of protocol documents for agency review
• Communicate with CTO research project sponsors (academic, federal, industry) to support compliance
• Interface with internal and external entities to compile required information related to the conduct of CTO trials
• Develop IRB submission packets, including writing abstracts, submitting standard forms, and drafting informed consent forms
• Provide and maintain a tracking system to assess progress of protocol review; maintain regulatory essential files for submitted and approved studies
• Review protocol revisions and amendments; amend consent forms as needed and determine whether amendments require IRB review in accordance with established guidelines
• Distribute amendments and IRB-approved informed consent forms to relevant university protocol holders
• Serve as the primary point of contact for dissemination of approved study materials, coordinating with internal and external departments to communicate updates effectively and timely
• Attend meetings and serve as the principal CTO contact to regulatory agencies, including FDA and IRBs
• Continually monitor federal and sponsor rules, regulations, and processes to identify and interpret new, updated, or changed requirements
• Provide regulatory updates and guidance to investigators and research staff on new or changed regulations; participate in audits and site visits

Requirements

• Bachelor’s Degree in biological sciences, health sciences, social sciences, or other medical field, or an equivalent combination of education and experience
• 1 year experience in research or administrative capacity working on research projects
• Knowledge of research regulations, guidelines, and compliance issues

Preferred Qualifications

• Experience developing informed consent documents and preparing regulatory documents
• Experience and knowledge of IRB and federal or industry sponsor processes and requirements

Location

• Primarily remote
• New employees must attend in-person training sessions and orientation during onboarding
• After onboarding, employees are expected to attend occasional in-person activities, such as meetings, audits, monitoring visits, and site initiation visits

Compensation & Benefits

• Not specified in the posting.

Additional Information

• Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post-offer process.
• The university is an equal opportunity employer, including veterans and disability.