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    Sponsor Dedicated Cra Ii

    Syneos Health
    5+ years
    Not Disclosed
    Remote - Europe
    10 Sept. 19, 2024
    Job Description
    Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

    Clinical Research Associate II

    Company Overview

    Syneos Health® is a premier fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We transform unique clinical, medical affairs, and commercial insights into tangible outcomes that address modern market needs.

    Our Clinical Development model centers around the customer and the patient, continuously seeking ways to simplify and enhance our operations, making Syneos Health a great partner to work with and a fantastic place to work.

    Join us in either a Functional Service Provider partnership or a Full-Service environment, collaborating with passionate problem solvers who innovate as a team to achieve customer goals. We are agile and committed to accelerating the delivery of therapies, driven by our passion to change lives.

    Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

    Why Syneos Health?

    We are dedicated to developing our people through career growth, supportive management, technical training, peer recognition, and a comprehensive rewards program. Our Total Self culture encourages authenticity, uniting us globally and ensuring everyone feels cared for and included. We believe that diversity in thought, background, and perspective fosters a workplace where everyone belongs.

    Job Responsibilities

    • Conduct site qualification, initiation, interim monitoring, management, and close-out visits—on-site or remotely—ensuring compliance with regulatory standards, ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and study protocols.
    • Evaluate site performance and communicate significant issues to the project team, developing appropriate action plans.
    • Ensure informed consent processes are properly performed and documented, safeguarding patient confidentiality.
    • Assess safety and data integrity at investigator sites, addressing protocol deviations and pharmacovigilance issues.
    • Conduct Source Document Reviews and verify the accuracy of clinical data entered in case report forms (CRFs).
    • Resolve queries effectively, guiding site staff to ensure timely closure within agreed timelines.
    • Manage investigational product (IP) inventory, ensuring compliance with protocols for dispensing and administration.
    • Review the Investigator Site File (ISF) for accuracy, reconciling it with the Trial Master File (TMF).
    • Document activities in accordance with SOPs, including communication logs, trip reports, and follow-up letters.
    • Support subject recruitment and retention strategies while tracking observations and action items to resolution.
    • Act as the primary liaison with study site personnel, ensuring compliance and training for site team members.
    • Prepare for and participate in Investigator Meetings and global clinical monitoring/project staff meetings.
    • Maintain audit readiness standards and assist with audit preparations and follow-up actions.

    For Real World Late Phase studies, you will also:

    • Provide comprehensive site support throughout the study lifecycle, from identification to close-out.
    • Conduct chart abstraction activities and collaborate with Sponsor affiliates and local country staff.
    • Train junior staff as needed and suggest potential sites based on local treatment patterns.

    Qualifications

    • Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.
    • Strong understanding of Good Clinical Practice (GCP), ICH Guidelines, and relevant regulatory requirements.
    • Prior monitoring experience, including all monitoring visits (SIV through close-out) from a CRO or Pharma.
    • Proficient in computer skills and adaptable to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Willingness to travel up to 50% regularly.

    About Syneos Health

    In the last five years, we have collaborated on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, managing over 200 studies across 73,000 sites with more than 675,000 trial patients. No matter your role, you’ll take initiative and challenge the status quo with us in a fast-paced and evolving environment.

    Additional Information:
    This job description is not exhaustive. The company may assign additional tasks and responsibilities as needed. Equivalent experience, skills, and education will also be considered. This description is intended to comply with applicable laws regarding recruitment and employment, including provisions for reasonable accommodations under the Americans with Disabilities Act.

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