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    Cra Ii

    Syneos Health
    2+ years
    Not Disclosed
    Serbia
    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: Clinical Research Associate II

    Company: Syneos Health®

    Company Overview

    Syneos Health® is a global biopharmaceutical solutions organization dedicated to accelerating customer success. We bring together clinical, medical affairs, and commercial insights to address modern market challenges. With over 29,000 employees across 110 countries, we are driven to deliver therapies faster, improving the lives of patients worldwide. Our culture values innovation, collaboration, and diversity, offering a dynamic work environment where every employee matters.

    Why Syneos Health

    • Employee Development: We prioritize career growth through training, peer recognition, and a total rewards program.
    • Total Self Culture: We foster an inclusive environment where employees can be authentic and supported.
    • Diversity and Inclusion: We celebrate diverse backgrounds, perspectives, and ideas, creating a place where everyone belongs.

    Job Responsibilities

    • Site Management:

      • Perform site qualification, initiation, monitoring, management, and close-out visits (both on-site and remotely) to ensure compliance with regulatory requirements, ICH-GCP guidelines, and study protocols.
      • Assess overall site performance and provide recommendations for improvement.
      • Evaluate informed consent process and ensure confidentiality, patient safety, and data integrity.
      • Manage the reconciliation of clinical data and address any discrepancies.
      • Monitor compliance with electronic data capture and clinical trial management systems.

    • Investigator Site File (ISF) Management:

      • Regularly review the ISF to ensure accuracy and completeness.
      • Ensure proper archiving and reconciliation of essential documents with the Trial Master File (TMF).

    • Clinical Data Management:

      • Conduct Source Document Reviews and ensure accuracy and completeness of data entered in the case report forms (CRFs).
      • Use query resolution techniques and provide guidance to site staff.
      • Verify investigational product (IP) inventory, storage, security, and administration in accordance with protocol.

    • Collaboration and Communication:

      • Act as primary liaison with study site personnel and collaborate with the central monitoring team.
      • Ensure that all site staff are adequately trained on study requirements.
      • Participate in investigator meetings, sponsor meetings, and clinical training sessions.
      • Document activities such as trip reports, follow-up letters, and communication logs.

    • Project Management Support:

      • Ensure project timelines, budgets, and deliverables are met by managing site-level activities.
      • Adapt quickly to changing priorities to meet study objectives.
      • Provide guidance to the site and project team for audit readiness.

    • Late Phase Real World Studies (Site Management Associate II title used):

      • Support sites from identification through close-out in late-phase studies.
      • Knowledgeable in local requirements for real-world study designs.
      • Assist with chart abstraction and data collection.
      • Collaborate with sponsors, medical science liaisons, and local affiliates.
      • Identify potential sites based on local treatment patterns and HCP relationships.

    Qualifications

    • Education:
      • Bachelor’s degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience.
    • Experience:
      • Knowledge of Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements.
      • Ability to manage required travel (up to 75% regularly).
      • Excellent communication, presentation, and interpersonal skills.
      • Strong computer skills and openness to embracing new technologies.

    Additional Information

    • The duties and responsibilities outlined in this description are not exhaustive and may evolve.
    • The company reserves the right to assign other tasks as necessary.
    • Equivalent experience or education may be considered in lieu of listed qualifications.
    • The company adheres to the Americans with Disabilities Act, providing reasonable accommodations when needed to assist employees in performing job functions.

    Why Work at Syneos Health

    Syneos Health is an industry leader, with over 200 studies conducted globally and a track record of working with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products. Join us and make a difference in the lives of patients worldwide.

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