Regulatory Specialist
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Job Description
Regulatory Specialist coordinating regulatory research activities for clinical trials at ObjectiveHealth. Ensuring compliance while managing documentation and collaborating with clinical teams.
Responsibilities:
- Maintain regulatory start-up and ongoing documentation throughout clinical trials.
- Ensure compliance with all IRB-approved protocols, sponsor requirements, company SOPs, HIPAA regulations, GCPs, and applicable state and federal laws.
- Create, review, file, and submit regulatory and training documents, ensuring completeness and accuracy.
- Track and maintain physician credentials, training logs, and delegation of authority forms.
- Follow up on pending signatures and missing documentation to ensure timely completion.
- Collaborate with internal teams, research staff, investigators, and external sponsors to facilitate effective communication and issue resolution.
- Prepare IRB submissions (initial protocols, amendments, safety updates, etc.).
- Review and edit Informed Consent Forms for regulatory and protocol compliance.
- Participate in study start-up, monitoring visits, internal/external audits, and regulatory inspections.
- Maintain up-to-date knowledge of clinical research regulations, GCP, and FDA/ICH guidance.
- Provide regulatory training to site staff as needed.
Requirements:
- Bachelor’s degree in life sciences, healthcare, or related field (preferred)
- 2+ years of experience in clinical research regulatory affairs or a similar role
- Strong understanding of GCP, ICH guidelines, FDA regulations, and IRB processes
- Excellent organizational, communication, and documentation skills
- Ability to manage multiple priorities and deadlines with strong attention to detail.
Benefits:
- Competitive compensation
- 401(k) with Company match
- Short- and Long-Term Disability
- Health Savings and Flexible Spending Accounts
- Health, Dental and Vision insurance Plans
- Generous PTO
- Adoption Assistance
- Paid Holidays
- Wide selection of other voluntary benefits
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