Role Overview
Manage regulatory compliance for clinical research networks and industry sponsors as a Clinical Regulatory Affairs Specialist II. Working fully remotely within the United States, you will ensure adherence to FDA, GCP, and institutional requirements across multiple studies and sites. This role demands precision, strong organizational skills, and the ability to meet strict regulatory timelines.
Key Responsibilities
- Develop and oversee an electronic document management system for regulatory records
- Prepare, update, and maintain essential study documents including protocols, investigator brochures, and informed consent forms in alignment with IRB and HIPAA guidelines
- Ensure all regulatory files meet required standards for content, format, and compliance with internal SOPs
- Coordinate and submit documentation for IRB review across multiple clinical trials
- Process and report protocol deviations that require IRB notification
- Submit urgent safety reports and amendments to regulatory boards within mandated timeframes
- Communicate effectively with sponsors and internal teams on time-sensitive regulatory matters
Qualifications
A high school diploma is required, though relevant experience may substitute for formal education. Candidates must have at least three years of experience in regulatory affairs within clinical research, pharmaceuticals, or site management organizations. An Associate’s degree or higher is preferred. Familiarity with medical terminology and regulatory frameworks such as FDA guidelines and GCP is strongly desired.
Work Environment & Benefits
This is a fully remote position open to candidates across the U.S. The organization operates with a mission to advance cancer care and improve patient outcomes. Benefits include comprehensive health and wellness support, a flexible remote structure, and a total rewards package that reflects experience, skills, and geographic market factors. Compensation includes base salary, with potential for annual bonuses or long-term incentives. Equity may be included based on role and performance.
Commitment to Inclusion
The organization is an equal opportunity employer and welcomes diversity in its workforce. It does not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
