Clinical Regulatory Specialist
Clinical Regulatory Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
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
Education:
- Bachelors degree in Life Sciences Public Health or a related field required.
- Advanced degree (e.g. MS MPH) preferred.
Experience:
- Minimum 35 years of experience in regulatory affairs clinical research or a related field.
- Familiarity with clinical trial management systems (CTMS) and electronic submission platforms.
Certifications:
- Regulatory Affairs Certification (RAC) or Certified Clinical Research Professional (CCRP) preferred.
- Skills:
- Strong knowledge of FDA ICHGCP and HIPAA regulations.
- Excellent organizational and communication skills.
- Ability to manage multiple priorities and meet deadlines.
Employment Type
Full Time
