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    Cra Ii / Sr Cra - Sponsor Dedicated - Rare Disease (Home-Based, Southeast 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

    Senior Clinical Research Associate I (CRA II / Sr CRA - Sponsor Dedicated - Rare Disease, Home-based, Southeast US)
    Updated: December 12, 2024
    Location: United States - North America - USA-Florida - Home-Based, United States
    Job ID: 24006596-FL975

    Job Description

    Senior Clinical Research Associate I

    Syneos Health® is a fully integrated biopharmaceutical solutions organization that drives customer success by translating unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities.

    Our Clinical Development model puts the customer and patient at the center of everything we do. We continuously innovate to simplify and streamline our processes, making Syneos Health easier to work with and for.

    Whether you work with us in a Functional Service Provider (FSP) partnership or within a Full-Service environment, you’ll collaborate with passionate problem solvers to accelerate the delivery of therapies that change lives.

    Why Syneos Health

    • Career Development: We invest in our people through career development programs, technical and therapeutic training, peer recognition, and a total rewards program.
    • Total Self Culture: Syneos Health fosters an inclusive and supportive environment where employees can be their authentic selves. Our culture of diversity brings us together, creating a place where everyone belongs.
    • Impactful Work: You’ll contribute to our shared mission of making a meaningful difference in the lives of patients and accelerating the development of innovative therapies.

    Job Responsibilities

    As a Senior Clinical Research Associate (CRA II / Sr CRA), you will oversee site qualification, initiation, interim monitoring, site management, and close-out visits. You will ensure regulatory, ICH-GCP, and protocol compliance while providing recommendations for site performance improvements. Key responsibilities include:

    • Site Monitoring: Perform site monitoring tasks such as assessing site processes, conducting Source Document Reviews, verifying clinical data in CRFs, and ensuring compliance with electronic data capture requirements.
    • Clinical Data Review: Apply query resolution techniques both remotely and on-site, and provide site staff guidance to close queries within timelines.
    • Investigational Product (IP) Management: Oversee IP inventory, reconciliation, and storage while ensuring dispensation and administration follow protocol.
    • Site File Management: Review the Investigator Site File (ISF) for accuracy and reconcile it with the Trial Master File (TMF).
    • Project Management: Manage site-level activities to ensure adherence to project timelines, budgets, and deliverables. Adapt quickly to changing priorities and ensure effective communication with all project stakeholders.
    • Training & Mentorship: Provide training and mentorship to junior CRAs and support site-level activities, including recruitment and retention strategies. Participate in training sessions and lead meetings as required.

    Additional duties for late-phase real-world studies (RWLP) include collaborating with the sponsor and local affiliates, suggesting potential study sites, and ensuring regulatory compliance.

    Qualifications

    What we’re looking for:

    • Education & Experience: A Bachelor’s degree in a related field or RN qualification, along with relevant experience in clinical research.
    • Regulatory Knowledge: Strong understanding of Good Clinical Practice (GCP), ICH Guidelines, and other regulatory requirements.
    • Communication Skills: Excellent communication, presentation, and interpersonal skills.
    • Travel Requirements: Must be able to travel up to 75% of the time.
    • Computer Skills: Proficiency in clinical trial management software and the ability to adapt to new technologies.

    Compensation & Benefits

    Syneos Health offers a competitive salary, with a range from $63,090 to $145,000 based on qualifications and experience. Benefits include:

    • Health coverage (Medical, Dental, Vision)
    • Company-matched 401(k)
    • Eligibility to participate in the Employee Stock Purchase Plan
    • Performance-based commissions/bonuses
    • Flexible Paid Time Off (PTO) and sick time
    • Company car or car allowance

    Get to Know Syneos Health

    Syneos Health has supported the development and commercialization of 94% of novel FDA-approved drugs over the last five years. Whether in clinical research or another role, you’ll contribute to groundbreaking work that impacts patient lives across the globe.

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