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    Sr Cra I (Finland) - Sponsor-Dedicated

    Syneos Health
    0-2 years
    Not Disclosed
    Falls Church Finland
    10 Nov. 23, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills:

    Senior Clinical Research Associate I (Sponsor-Dedicated) - Syneos Health®

    Company Overview: Syneos Health® is a global leader in providing fully integrated biopharmaceutical solutions. Our approach accelerates customer success by transforming unique clinical, medical affairs, and commercial insights into impactful outcomes. We prioritize making the patient and customer the center of everything we do, continuously striving to simplify and streamline our processes.

    Our global workforce of over 29,000 employees across 110 countries is passionate about accelerating the delivery of therapies that change lives. At Syneos Health, we are committed to building a diverse and inclusive culture where every team member feels like they belong.

    Why Syneos Health?

    We are passionate about developing our people through career progression, continuous technical training, peer recognition, and a comprehensive rewards program. Our Total Self culture encourages everyone to bring their authentic selves to work, ensuring a diverse, supportive, and engaging environment. We’re continuously building the company we want to work for, where innovation thrives, and inclusion is a key driver of success.

    Key Responsibilities:

    1. Site Monitoring and Management:

      • Conduct site qualification, initiation, interim monitoring, site management, and close-out visits (both on-site and remotely) while ensuring compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and study protocols.
      • Assess site performance and provide site-specific recommendations. Escalate serious issues to the project team, developing appropriate action plans.
      • Ensure informed consent is obtained and documented as per protocol, maintaining confidentiality and safeguarding clinical data integrity.

    2. Clinical Data Verification:

      • Perform Source Document Reviews to ensure clinical data entered into the Case Report Form (CRF) is accurate and complete.
      • Drive query resolution and provide guidance to site staff to ensure data quality and compliance.
      • Ensure compliance with electronic data capture systems and tools.

    3. Investigational Product (IP) Management:

      • Oversee IP inventory, reconciliation, storage, security, dispensing, and administration as per protocol.
      • Ensure IP labeling, importation, and return processes adhere to GCP and local regulations.
      • Verify the blinded or randomized information associated with IP management.

    4. Documentation and Reporting:

      • Maintain accurate documentation through confirmation letters, trip reports, and communication logs, per SOPs.
      • Track project status, actions, and issues to ensure timely resolution and achievement of project objectives.
      • Support recruitment and retention strategies, helping to ensure patient awareness and compliance.

    5. Project and Site Coordination:

      • Ensure site-level activities, communication, and timelines are well-managed, meeting project deliverables.
      • Act as the primary liaison with site personnel, ensuring all team members are adequately trained and compliant.
      • Participate in Investigator Meetings, sponsor meetings, and clinical training sessions as required by the project.

    6. Audit and Quality Assurance:

      • Maintain site audit readiness standards and support preparation for audits and follow-up actions.
      • Provide mentorship to junior-level CRAs and support their training, as needed.
      • Ensure compliance with local regulatory guidelines and assist in preparing country-level informed consent forms.

    7. Real World Late Phase (RWLP) Responsibilities:

      • Support site activities throughout the study lifecycle, from identification through close-out.
      • Identify potential sites based on local treatment patterns, patient advocacy, and healthcare provider associations.
      • Collaborate with RWLP Regulatory teams to ensure regulatory information is up-to-date.

    8. Additional Responsibilities:

      • Suggest process improvements and operational efficiencies based on project learnings.
      • Assist in bid defense meetings and collaborate with the sponsor and other affiliates on study design and execution.

    Qualifications:

    • Education: Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
    • Experience: Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and relevant regulatory requirements. Previous clinical research experience is preferred.
    • Skills:
      • Proficiency with clinical research software and tools.
      • Excellent communication, presentation, and interpersonal skills.
      • Critical thinking abilities and problem-solving capabilities.
      • Ability to manage frequent travel (up to 75%).

     

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