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    Sr Cra I - Sponsor Dedicated - United Kingdom (Homebased)

    Syneos Health
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 21, 2024
    Job Description
    Job Type: Full Time 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

    Job Title: Senior Clinical Research Associate I
    Company: Syneos Health
    Location: Remote/Various Locations (Travel Required)

    About Syneos Health:
    Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success. By translating clinical, medical affairs, and commercial insights into impactful outcomes, we address modern market realities. Our Clinical Development model places the patient and customer at the center of everything we do. We continuously work towards simplifying and streamlining processes to ensure we are easy to work with and for.

    Why Syneos Health:

    We are dedicated to developing our people through career growth, training, and mentorship while promoting a Total Self culture where everyone can authentically be themselves. This inclusive environment fosters creativity and success through diverse perspectives. Join us, and help us shape the future of clinical research.

    Job Overview:

    The Senior Clinical Research Associate I (Sr. CRA I) will be responsible for conducting site qualification, initiation, monitoring, and close-out visits while ensuring compliance with regulatory guidelines, ICH-GCP, and study protocols. You will oversee site performance, manage issues, and ensure the successful delivery of study outcomes, all while maintaining strong site relationships and supporting both internal and external stakeholders.

    Key Responsibilities:

    • Conduct site qualification, initiation, monitoring, and close-out visits (on-site or remotely), ensuring full compliance with regulatory standards (ICH-GCP, GPP) and study protocols.
    • Assess site performance and escalate serious issues promptly. Develop and implement action plans for improving site performance.
    • Verify the informed consent process, ensuring documentation is thorough and compliant with regulatory requirements.
    • Perform Source Document Reviews to ensure accurate and complete data entry in Case Report Forms (CRFs).
    • Resolve queries remotely and on-site, offering guidance to site staff and ensuring timely query closure.
    • Support investigational product (IP) management, verifying proper inventory, storage, and administration according to the protocol.
    • Review and reconcile Investigator Site Files (ISF) with Trial Master File (TMF) to ensure compliance with archiving standards.
    • Document project activities through trip reports, communication logs, and other required reports in line with SOPs and Clinical Monitoring Plans.
    • Manage site-level communication and ensure project timelines and objectives are met.
    • Act as the primary liaison with study site personnel and collaborate with the Central Monitoring Associate as needed.
    • Participate in Investigator Meetings, sponsor meetings, and clinical training sessions to stay updated on project requirements.
    • Support audit readiness at both the site and project levels, ensuring necessary preparations for audits and follow-up actions.
    • May mentor or train junior-level CRAs and assist with the training and sign-off of visits for junior staff.
    • Support Real World Late Phase (RWLP) activities by providing site support, conducting chart abstraction, and collecting data.
    • Collaborate with sponsors, medical science liaisons, and local staff to ensure smooth study operations.
    • Propose operational efficiencies and process improvements based on experience.
    • Participate in bid defense meetings and contribute insights into study design and implementation.

    Qualifications:

    • 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 other relevant regulatory requirements.
    • Strong computer skills and the ability to adopt new technologies.
    • Excellent communication, interpersonal, and presentation skills.
    • Basic critical thinking abilities to analyze site performance and resolve issues.
    • Ability to manage up to 75% travel on a regular basis.

    Get to know Syneos Health:

    Syneos Health has contributed to the success of 94% of all novel FDA-approved drugs and 95% of EMA-authorized products, managing over 200 studies across 73,000 sites and 675,000+ trial patients globally.

    Apply Now: Syneos Health Careers

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