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Lalande-de-Pomerol

    Senior Compliance Officer - Miami, United States - CRO Strategies

    CRO Strategies
    CRO Strategies Miami, United States

    3 weeks ago

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    Description

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

    Be one of the first applicants, read the complete overview of the role below, then send your application for consideration.

    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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