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    Senior Cra I - Must Have Neurology (Multiple Sclerosis) Expereince - Sponsor Dedicated - Bulgaria (H

    Syneos Health
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 21, 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, 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 integrated biopharmaceutical solutions organization dedicated to accelerating the success of our clients. We combine clinical, medical affairs, and commercial expertise to help bring new treatments to market, with a focus on simplifying and streamlining operations to benefit both our clients and our people. Whether through Functional Service Provider partnerships or Full-Service solutions, we work collaboratively to deliver innovative therapies that change lives.

    Why Syneos Health:
    At Syneos Health, we are committed to developing our people through career progression, professional development, and a culture that fosters diversity, empowerment, and respect. Our Total Self culture encourages you to bring your authentic self to work, and we continuously strive to be the company that everyone wants to work for.

    Job Overview:

    We are looking for a Senior Clinical Research Associate I (Sr. CRA I) to join our growing clinical operations team. This role will involve conducting site qualification, initiation, monitoring, and close-out visits—ensuring adherence to regulatory requirements, ICH-GCP guidelines, and protocol compliance. The Sr. CRA I will be responsible for managing site performance, driving data quality, and collaborating with site teams to ensure successful clinical trials.

    Job Responsibilities:

    • Perform site management activities such as qualification, initiation, monitoring, and close-out visits (on-site or remote).
    • Ensure compliance with ICH-GCP, local regulations, and study protocols.
    • Oversee informed consent processes, ensuring proper documentation and patient confidentiality.
    • Conduct Source Document Reviews and verify the accuracy of clinical data entered in case report forms (CRFs).
    • Utilize query resolution techniques to resolve data discrepancies and ensure timely closure of queries.
    • Monitor Investigational Product (IP) inventory, storage, and security; ensuring protocol compliance in dispensing and handling.
    • Review Investigator Site Files (ISF) and reconcile with Trial Master Files (TMF).
    • Document activities in accordance with SOPs, Clinical Monitoring Plans, and Site Management Plans (CMP/SMP).
    • Support subject recruitment, retention, and awareness strategies.
    • Collaborate with project teams to ensure project timelines, deliverables, and objectives are met.
    • Act as the primary liaison with study site personnel, ensuring compliance with study-specific training and requirements.
    • Prepare for and attend Investigator Meetings and sponsor meetings, contributing to clinical project staff meetings.
    • Support audit readiness and ensure preparation for inspections and follow-up actions.
    • Provide mentorship and training to junior CRAs and assist with site management activities.
    • For Real World Late Phase (RWLP), perform site support activities throughout the study lifecycle, from site identification to close-out.
    • Collect chart abstraction and collaborate with medical science liaisons, local country staff, and affiliates.
    • Suggest operational efficiencies and process improvements.
    • Participate in bid defense meetings and collaborate with the RWLP regulatory team on updated regulatory requirements.

    Qualifications:

    • Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
    • Strong knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other regulatory requirements.
    • Proficient in clinical monitoring and the use of relevant technologies for data review.
    • Excellent communication, organizational, and interpersonal skills.
    • Ability to manage up to 75% travel regularly.
    • Basic critical thinking skills to assess site performance and resolve issues.

    Get to know Syneos Health:
    In the past five years, Syneos Health has contributed to the success of 94% of all novel FDA-approved drugs and 95% of EMA-authorized products, with over 200 studies completed across 73,000 sites and more than 675,000 trial patients.

    Apply Now: Syneos Health Careers

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