What are the responsibilities and job description for the Clinical Regulatory Specialist position at Whitecollars?
About the Role
We are seeking a dedicated Clinical Regulatory Specialist to ensure compliance with regulatory standards and manage the submission and maintenance of clinical trial documents. The ideal candidate will have a strong understanding of FDA, IRB, and HIPAA regulations, as well as experience supporting clinical research initiatives. This role is critical in maintaining the integrity of clinical trials and ensuring adherence to all regulatory requirements.
Key Responsibilities
- Regulatory Submissions : Prepare, review, and submit regulatory documents, including protocols, amendments, informed consent forms, and annual reports, to IRBs and other governing bodies.
- Compliance Management : Ensure all clinical research activities comply with FDA, IRB, and HIPAA guidelines, as well as applicable federal, state, and institutional regulations.
- Documentation Oversight : Maintain accurate and organized regulatory documentation, ensuring timely updates and renewals as required.
- Liaison Role : Act as the primary point of contact between research teams and regulatory agencies to address questions, provide updates, and resolve issues.
- Audit Preparation : Assist in preparing for internal and external audits, ensuring readiness and addressing any findings promptly.
- Training Support : Provide regulatory guidance and training to clinical research staff to ensure understanding and adherence to compliance standards.
- Policy Development : Collaborate with teams to develop and refine regulatory policies and procedures.
Qualifications
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