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Doral

    Senior Compliance Officer - Doral, United States - CRO Strategies

    CRO Strategies
    CRO Strategies Doral, 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.


    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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