Are you an experienced compliance professional with a passion for ensuring ethical and regulatory excellence in clinical research? Join our esteemed client, a leading Medical Center in the heart of San Francisco, CA, as a Clinical Research Compliance Manager. We are seeking a dedicated leader to ensure the highest standards of compliance across clinical research programs.
About Our Client:
Our client is a premier Medical Center known for its cutting-edge research and dedication to advancing patient care. With a focus on groundbreaking clinical trials and medical research, they are committed to upholding the highest ethical standards and regulatory compliance. As they continue to expand their research initiatives, they seek a skilled compliance professional to lead their clinical research compliance efforts.
Responsibilities of Clinical Research Compliance Manager:
As the Clinical Research Compliance Manager, you will be responsible for:
- Regulatory Compliance: Ensuring all clinical research activities comply with federal, state, and local regulations, including FDA and HIPAA guidelines.
- Policy Development: Creating and implementing comprehensive compliance policies and procedures to govern clinical research operations.
- Audit Oversight: Leading internal audits and preparing for external inspections to ensure compliance with regulatory requirements.
- Training and Education: Developing and conducting compliance training programs for research staff, ensuring adherence to ethical standards and legal requirements.
- Risk Management: Identifying potential compliance risks and implementing strategies to mitigate those risks in clinical research processes.
- Collaboration: Working closely with principal investigators, research teams, and legal departments to ensure all research projects align with ethical and regulatory standards.
Qualifications:
To succeed in the role of Clinical Research Compliance Manager, you should possess:
- Extensive Experience: Proven experience in clinical research compliance, preferably in a medical or academic setting.
- Regulatory Knowledge: In-depth knowledge of FDA, HIPAA, GCP, and other relevant regulations governing clinical research.
- Leadership Skills: Strong leadership and interpersonal skills with the ability to guide and influence cross-functional teams.
- Problem-Solving Ability: Excellent analytical and problem-solving skills to address compliance challenges and drive process improvements.
- Educational Background: A bachelor’s degree in a relevant field such as Clinical Research, Healthcare Compliance, or Regulatory Affairs; advanced certifications like CCRC or CHRC are highly desirable.
How to Apply:
If you are a compliance expert passionate about ethical research and ready to make a significant impact, we encourage you to submit your resume and cover letter outlining your qualifications and vision for the role. Join our client’s team in shaping the future of clinical research and advancing medical science.
Looking for more leadership opportunities in clinical research? Visit our Expert Medical Executive Recruitment page and explore top positions in the field today!
