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    Sr Cra Ii

    Syneos Health
    4-6 years
    Not Disclosed
    Remote - Europe
    10 July 16, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

    Position: Senior Clinical Research Associate II
    Company: Syneos Health

    Company Overview:

    Syneos Health® is a leading biopharmaceutical solutions organization that integrates clinical, medical affairs, and commercial insights to address modern market realities. Our Clinical Development model centers on the customer and the patient, striving to simplify and streamline processes to facilitate ease of collaboration.

    Why Syneos Health:

    • Career Development: Commitment to employee growth through career progression, supportive management, technical and therapeutic training, peer recognition, and a comprehensive rewards program.
    • Total Self Culture: Dedicated to creating an inclusive environment where employees can authentically be themselves, fostering a sense of belonging and diversity of thought.
    • Global Reach: Join a team of 29,000 employees across 110 countries, working together to bring therapies to market and change lives.

    Job Summary:

    As a Senior Clinical Research Associate II, you will perform site qualification, initiation, interim monitoring, site management, and close-out visits to ensure compliance with regulatory, ICH-GCP, GPP, and protocol standards. You will provide site-specific recommendations and escalate serious issues to the project team, maintaining a working knowledge of ICH/GCP Guidelines and company SOPs.

    Key Responsibilities:

    • Site Management:
      • Perform site visits (on-site or remotely) to ensure compliance with regulatory and protocol standards.
      • Evaluate site and staff performance and develop action plans for site-specific issues.
    • Informed Consent:
      • Verify informed consent processes and documentation for each subject/patient.
      • Protect subject/patient confidentiality and assess safety and data integrity factors.
    • Clinical Monitoring/Site Management Plan (CMP/SMP):
      • Assess site processes and conduct Source Document Review.
      • Verify clinical data accuracy and completeness in case report forms (CRFs).
      • Resolve queries and provide guidance to site staff, ensuring timely query resolution.
      • Ensure site compliance with electronic data capture requirements.
    • Investigational Product (IP) Management:
      • Perform IP inventory, reconciliation, and review storage and security.
      • Verify IP dispensation and administration according to the protocol.
      • Ensure IP is appropriately labeled, imported, and released/returned.
    • Documentation and Reporting:
      • Review Investigator Site File (ISF) for accuracy and completeness.
      • Document activities via confirmation letters, follow-up letters, trip reports, and communication logs.
      • Support subject/patient recruitment, retention, and awareness strategies.
      • Enter data into tracking systems to monitor observations and action items.
    • Audit and Compliance:
      • Prepare for and attend Investigator Meetings and sponsor meetings.
      • Provide guidance for audit readiness and follow-up actions.
      • Participate in and lead global clinical monitoring/project staff meetings.
      • Provide training and mentorship to junior CRA staff as needed.

    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/ICH Guidelines and regulatory requirements.
      • Excellent computer skills and adaptability to new technologies.
      • Strong communication, presentation, and interpersonal skills.
      • Ability to manage up to 75% travel on a regular basis.
    • Skills:
      • Moderate level of critical thinking skills.
      • Ability to quickly adapt to changing priorities and achieve project goals.
      • Effective management of site-level activities and communication.

    Additional Information:

    • The job description is not exhaustive, and the company may assign other tasks and responsibilities as needed.
    • The company values diversity and encourages applicants from various backgrounds to apply.
    • Compliance with the Americans with Disabilities Act, including reasonable accommodations, is a priority.

    Apply for this job
    Not ready to apply? Join our Talent Network

    Syneos Health is committed to building a diverse, inclusive, and authentic workplace. If your experience doesn’t align perfectly, we encourage you to apply and join our Talent Network for additional career opportunities.

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