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    Sponsor Dedicated Cra Ii/ Sr Cra

    Syneos Health
    1+ years
    Not Disclosed
    Remote - Europe
    10 Aug. 5, 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

    Sponsor Dedicated CRA II / Sr CRA (Home-Based ITA)

    Syneos Health® is a premier biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage clinical, medical affairs, and commercial insights to deliver results that align with modern market realities.

    Our Approach: We place the customer and patient at the heart of our Clinical Development model. Our continuous efforts to simplify and streamline processes not only enhance our partnership with clients but also make Syneos Health an excellent place to work.

    Join Our Team: Whether you are part of a Functional Service Provider partnership or a Full-Service environment, you will collaborate with innovative problem solvers. Our agile approach is driven by a passion to expedite the delivery of therapies and change lives.

    Discover Syneos Health: With 29,000 employees across 110 countries, we know that work here matters everywhere.

    Why Syneos Health: We are dedicated to career development, offering supportive management, technical and therapeutic training, peer recognition, and comprehensive rewards programs. Our Total Self culture encourages authenticity and unity, fostering a workplace where everyone feels they belong. We are continuously building an inclusive environment that attracts diverse thoughts, backgrounds, cultures, and perspectives.

    Job Responsibilities:

    • Perform site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remotely) to ensure compliance with regulatory, ICH-GCP, and Good Pharmacoepidemiology Practice (GPP) guidelines.
    • Evaluate site and staff performance, provide site-specific recommendations, and escalate serious issues to the project team, developing action plans as necessary.
    • Ensure the informed consent process is properly documented and protect subject/patient confidentiality.
    • Assess factors affecting subject/patient safety and clinical data integrity, including protocol deviations and pharmacovigilance issues.

    Clinical Monitoring/Site Management Plan:

    • Assess site processes.
    • Conduct Source Document Review.
    • Verify clinical data accuracy in case report forms (CRF).
    • Apply query resolution techniques and provide guidance to site staff.
    • Ensure compliance with electronic data capture requirements.
    • Perform investigational product (IP) inventory, reconciliation, and review storage/security.
    • Maintain the Investigator Site File (ISF) and reconcile with the Trial Master File (TMF).
    • Document activities through various reports and logs.
    • Support subject/patient recruitment, retention, and awareness strategies.
    • Manage site-level activities and communications to meet project objectives and timelines.
    • Act as primary liaison with study site personnel and ensure compliance with requirements.
    • Prepare for and attend Investigator Meetings and sponsor meetings.
    • Provide guidance for audit readiness and support follow-up actions.
    • Maintain knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.

    Real World Late Phase (RWLP) Responsibilities:

    • Support site activities throughout the study lifecycle.
    • Understand local requirements for late phase study designs.
    • Conduct chart abstraction activities and data collection.
    • Collaborate with Sponsor affiliates, medical science liaisons, and local staff.
    • Train junior staff as required.
    • Identify and communicate out-of-scope activities.
    • Suggest potential sites based on local knowledge.

    Qualifications:

    • Minimum 1 year of experience as a Certified CRA.
    • Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements.
    • Proficient computer skills and adaptability to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage up to 75% travel regularly.

    Get to Know Syneos Health: In the past 5 years, we have collaborated on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, across 200+ studies involving 73,000 sites and 675,000+ trial patients.

    Additional Information: Tasks, duties, and responsibilities in this job description are not exhaustive. Syneos Health reserves the right to assign other tasks and responsibilities. We consider equivalent experience, skills, and education for qualifications. This job description does not create an employment contract. We comply with all legal obligations, including the EU Equality Directive and the Americans with Disabilities Act, providing reasonable accommodations as necessary.

    Apply Now or Join Our Talent Network: At Syneos Health, we strive to create a diverse, inclusive, and authentic workplace. If your experience doesn't align perfectly, we encourage you to apply. We value transferable skills and encourage joining our Talent Network for future opportunities.

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