- Ensure that all clinical trials conducted at the site comply with federal, state, and local regulations, including FDA, ICH, GCP, HIPAA, and other relevant laws.
- Monitor changes in regulatory requirements and update site policies and procedures accordingly.
- Collaborate with regulatory agencies during inspections and audits.
- Develop, implement, and maintain a quality management system to ensure compliance with all applicable guidelines.
- Conduct internal audits to identify potential compliance risks and recommend corrective actions.
- Oversee the implementation of corrective and preventive action plans (CAPA).
- Develop and deliver compliance training programs for clinical research staff.
- Keep the team informed about regulatory changes, best practices, and compliance trends.
- Ensure that all staff complete required training and maintain certifications as needed.
- Identify compliance risks and develop strategies to mitigate them.
- Ensure that adverse events and safety issues are reported in accordance with regulatory requirements.
- Participate in risk assessment and contingency planning.
- Ensure that research activities meet ethical standards, including obtaining informed consent and protecting patient confidentiality.
- Serve as a liaison with institutional review boards (IRBs) and ethics committees.
- Maintain accurate records of compliance activities, audits, and training sessions.
- Prepare and submit compliance reports to senior management and regulatory agencies.
- Ensure proper documentation of clinical trial activities and compliance-related information.
- Collaborate with other departments, such as Legal, Quality Assurance, and Clinical Operations, to ensure a consistent approach to compliance.
- Communicate compliance issues and findings to stakeholders and recommend solutions.
- Represent the site in compliance-related meetings and discussions with external partners.
- Bachelor's degree in a related field (e.g., life sciences, healthcare, or regulatory affairs); advanced degree preferred.
- A minimum of 5 years of experience in clinical research compliance or a related field.
- Strong knowledge of FDA regulations, GCP, ICH guidelines, and other applicable regulatory frameworks.
- Excellent organizational, communication, and analytical skills.
- Experience in conducting audits and investigations.
- Ability to work independently and as part of a team.
- Relevant certification (e.g., Certified Clinical Research Professional, Certified Compliance and Ethics Professional) is desirable.
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Senior Compliance Officer - Miami, United States - CRO Strategies
Description
The Senior Compliance Officer plays a critical role in promoting a culture of compliance, risk management, and quality assurance.
Key Responsibilities:
Regulatory Compliance:
Quality Assurance:
Training and Education:
Risk Management:
Ethics and Patient Safety:
Documentation and Reporting:
Communication and Collaboration:
Qualifications:
