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    Sr Cra I (Finland) - Sponsor-Dedicated

    Syneos Health
    2+ years
    Not Disclosed
    Finland
    10 Nov. 23, 2024
    Job Description
    Job Type: Remote Education: RN/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Senior Clinical Research Associate I (Sponsor-Dedicated)

    Company: Syneos Health

    About Syneos Health

    Syneos Health® is a global leader in biopharmaceutical solutions, integrating clinical, medical, and commercial insights to accelerate customer success.

    Our approach focuses on bringing customers and patients to the center of everything we do, streamlining operations to deliver impactful results.

    With 29,000 employees in 110 countries, Syneos Health is committed to creating an innovative, inclusive, and collaborative workplace that drives meaningful outcomes.

    Why Join Syneos Health?

    • Career Development: Opportunities for growth, training, and professional progression.
    • Inclusive Culture: Total Self Culture encourages authenticity and belonging.
    • Supportive Environment: Peer recognition, engaged management, and rewards programs.
    • Global Impact: Contribute to advancing therapies and transforming patient lives.

    Job Responsibilities

    Site Management and Monitoring

    • Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remote).
    • Ensure compliance with ICH-GCP, regulatory guidelines, protocols, and company SOPs.
    • Evaluate site performance, escalate critical issues, and develop corrective action plans.
    • Verify informed consent processes and ensure subject confidentiality.

    Clinical Data Oversight

    • Conduct Source Document Review (SDR) and verify clinical data accuracy in case report forms (CRFs).
    • Resolve data queries and guide site staff to ensure timely closure.
    • Ensure compliance with electronic data capture (EDC) requirements.

    Investigational Product (IP) Management

    • Perform IP inventory, reconciliation, and storage/security reviews.
    • Verify proper dispensing and administration of investigational products.
    • Ensure compliance with GCP/local regulations and organizational procedures.

    Documentation and Compliance

    • Maintain and reconcile the Investigator Site File (ISF) with the Trial Master File (TMF).
    • Document site activities via trip reports, confirmation letters, and communication logs.
    • Support subject recruitment, retention, and awareness initiatives.

    Collaboration and Audit Readiness

    • Act as a primary liaison with project site personnel and collaborate with Central Monitoring Associates.
    • Participate in Investigator Meetings, sponsor face-to-face meetings, and clinical training sessions.
    • Provide site guidance to ensure audit readiness and support audit preparations.

    Mentorship and Leadership

    • Provide training and mentorship to junior CRAs, including training and sign-off visits.
    • Perform clinical operations lead tasks under supervision, as needed.

    Real-World Late Phase (RWLP) Studies

    • Support sites throughout the study lifecycle, including site identification and close-out.
    • Conduct chart abstraction and data collection activities.
    • Collaborate with Sponsor affiliates, medical science liaisons, and healthcare professionals.
    • Identify and suggest potential sites based on local knowledge of treatment patterns.
    • Develop informed consent forms and support regulatory compliance.
    • Participate in bid defense meetings and identify process improvements.

    Qualifications

    Education and Experience

    • Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
    • Knowledge of Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements.

    Skills and Competencies

    • Proficient with computers and adaptable to new technologies.
    • Strong communication, presentation, and interpersonal skills.
    • Basic critical thinking skills.
    • Ability to manage travel requirements of up to 75%.

    Syneos Health’s Impact

    • Supported 94% of FDA-approved drugs and 95% of EMA-authorized products in the last 5 years.
    • Conducted over 200 studies at 73,000 sites, engaging 675,000+ trial participants.

    Syneos Health drives innovation and challenges the status quo to deliver transformative solutions in a dynamic global environment.

    Additional Information

    • Responsibilities may vary based on business needs, with equivalent experience and skills considered.
    • Committed to compliance with local regulations, including the EU Equality Directive and ADA.
    • Reasonable accommodations provided to support employees/applicants in fulfilling essential job functions.

    Learn more about Syneos Health at Syneos Health.

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