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    Cra Ii / Sr Cra - Sponsor Dedicated - Rare Disease (Home-Based, Northeast Of Us)

    Syneos Health
    2+ years
    Not Disclosed
    Remote
    10 Dec. 30, 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

    CRA II / Sr CRA - Sponsor Dedicated - Rare Disease (Home-based, Northeast of US)
    Updated: December 12, 2024
    Location: United States-North America - USA-Virginia-Home-Based, United States
    Job ID: 24006594-VA975

    Job Description

    Senior Clinical Research Associate I

    Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We bring clinical, medical affairs, and commercial insights to the forefront to address modern market challenges.

    At Syneos Health, our Clinical Development model keeps the customer and patient at the center of everything we do. We are always seeking ways to simplify our work processes, making Syneos Health easier to work with and for. By joining us, you’ll collaborate with innovative and passionate problem-solvers to help our customers achieve their goals.

    Why Syneos Health

    • Career Growth: We are committed to developing our people through continuous training, career progression, and peer recognition.
    • Inclusive Culture: Our Total Self culture values diverse perspectives and encourages you to be your authentic self.
    • Global Impact: Syneos Health has worked with 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and over 200 studies worldwide.

    Job Responsibilities

    As a Senior Clinical Research Associate I, you will perform clinical monitoring and site management activities throughout the study lifecycle. Key responsibilities include:

    • Site Management: Conduct site qualification, initiation, interim monitoring, and close-out visits, both remotely and on-site, ensuring compliance with regulatory, ICH-GCP, and protocol standards.
    • Data Review & Documentation: Perform Source Document Reviews, verify data accuracy in case report forms (CRFs), and resolve queries in collaboration with site staff.
    • Clinical Operations: Ensure investigational products are dispensed and administered according to protocol, and maintain site compliance with data capture and IP storage requirements.
    • Site Support: Manage site-level activities, resolve issues, and ensure the site is trained on clinical monitoring protocols and regulatory requirements.
    • Project Coordination: Support subject recruitment, retention, and awareness strategies. Track project observations and action items to resolution.
    • Audit Readiness: Support site preparation for audits and assist in maintaining audit readiness.
    • Training and Mentorship: Provide guidance and mentorship to junior CRAs and lead training sessions when needed.
    • Real World Late Phase (RWLP) Studies: Participate in activities such as chart abstraction and data collection, and collaborate with local teams and medical science liaisons.

    Additional duties include participating in bid defense meetings and supporting operational efficiencies and process improvements.

    Qualifications

    What we’re looking for:

    • Education & Experience: Bachelor’s degree or RN in a related field, or an equivalent combination of education and experience.
    • Clinical Knowledge: Strong understanding of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.
    • Skills: Excellent communication, interpersonal, and critical thinking skills. Proficiency in computer systems and technologies is essential.
    • Travel Requirements: Ability to manage up to 75% travel regularly.

    Compensation & Benefits

    Syneos Health offers a competitive salary and benefits package, including a company car or car allowance, medical, dental, and vision coverage, 401(k) match, employee stock purchase plan, performance-based commissions/bonus, flexible PTO, and sick time.

    The base salary range for this position is $63,090 to $145,000, depending on qualifications, experience, and skill set.

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