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    Cra2 Or Sr Cra

    Syneos Health
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 6, 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

    About Syneos Health:

    Syneos Health® is a leading integrated biopharmaceutical solutions organization that accelerates customer success by transforming clinical, medical, and commercial insights into actionable outcomes. Our focus is on putting the customer and the patient at the center of everything we do. We continuously innovate to simplify and streamline our operations, making Syneos Health both easier to collaborate with and a great place to work.

    As part of our team, you'll work alongside passionate problem-solvers in an agile environment, helping our clients bring new therapies to market faster while improving lives.

    Why Syneos Health?

    We’re committed to developing our people by fostering career growth, providing robust training, and offering a comprehensive total rewards program. Our Total Self culture unites us across the globe, ensuring that every employee can authentically be themselves. Diversity, equity, and inclusion are key pillars that make Syneos Health a place where everyone feels they belong.

    Job Responsibilities:

    As a Senior Clinical Research Associate I (CRA I), your role will involve key responsibilities throughout the study lifecycle, ensuring study compliance, patient safety, and data integrity. You will:

    Site Management & Monitoring:

    • Perform site qualification, initiation, interim monitoring, and close-out visits, both on-site and remotely, ensuring compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and protocol guidelines.
    • Use professional judgment to assess site performance, identify issues, and provide actionable recommendations.
    • Escalate serious issues and work closely with the project team to develop corrective action plans.
    • Verify informed consent processes and ensure patient confidentiality and safety throughout the study.
    • Review and verify clinical data entry, ensuring accuracy and completeness through Source Document Review (SDR) and Source Data Verification (SDV).

    Investigational Product (IP) Management:

    • Oversee IP inventory and ensure proper storage, dispensing, and administration in line with study protocols.
    • Ensure compliance with local regulations and GCP in the handling of blinded or randomized IP.

    Site Communication & Documentation:

    • Ensure Investigator Site File (ISF) is complete, accurate, and reconciled with the Trial Master File (TMF).
    • Document monitoring activities in compliance with SOPs and Clinical Monitoring Plans (CMP).
    • Track all observations, action items, and site progress through tracking systems to resolution.
    • Support subject recruitment and retention strategies in collaboration with site teams.

    Training & Mentorship:

    • Train and mentor junior CRAs, providing guidance on monitoring practices and site management activities.
    • Support audit readiness, ensuring sites comply with audit preparation standards and managing any follow-up actions.

    Project & Sponsor Interaction:

    • Participate in Investigator Meetings and sponsor face-to-face meetings.
    • Lead or contribute to global clinical monitoring/project staff meetings and ensure smooth communication across study teams.
    • Help prepare and support audit readiness activities and audit follow-up actions.

    Real World Late Phase (RWLP) Studies:

    • For RWLP, support activities across the study lifecycle, from site identification through to close-out.
    • Engage in chart abstraction activities and data collection as required by study protocols.
    • Collaborate with local teams to ensure compliance with regional and regulatory requirements.

    Qualifications:

    • Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
    • Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.
    • Proficiency with clinical monitoring tools, data capture systems, and modern technologies.
    • Strong communication, presentation, and interpersonal skills.
    • Ability to travel up to 75% for site visits and study-related activities.

    Why Work at Syneos Health?

    Syneos Health is proud to have contributed to 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products. We have supported over 200 studies across 73,000 sites, helping to improve the lives of more than 675,000 trial patients.

    Join us and challenge the status quo while being part of a highly competitive and rapidly evolving industry.

    Ready to make a difference? Apply now and help us deliver therapies that matter.

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