Senior Compliance Officer

4 weeks ago

Doral, United States CRO Strategies Full time

The Senior Compliance Officer plays a critical role in promoting a culture of compliance, risk management, and quality assurance.

Key Responsibilities:

Regulatory Compliance:

  • 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.

Quality Assurance:

  • 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).

Training and Education:

  • 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.

Risk Management:

  • 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.

Ethics and Patient Safety:

  • 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.

Documentation and Reporting:

  • 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.

Communication and Collaboration:

  • 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.

Qualifications:

  • 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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