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    Cra Ii Madrid. Experience In Neurology. Sponsor Dedicated

    Syneos Health
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 20, 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

    Clinical Research Associate II
    Location: Home-Based

    Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success. We transform clinical, medical affairs, and commercial insights into meaningful outcomes that meet the challenges of today's evolving market.

    Our Clinical Development model places customers and patients at the heart of everything we do, simplifying our work to make Syneos Health easier to collaborate with and more rewarding to work for. Whether you're part of a Functional Service Provider partnership or a Full-Service environment, you'll work with passionate problem-solvers to deliver therapies that can change lives.

    Why Syneos Health?

    At Syneos Health, we're passionate about developing our people through career progression, supportive management, ongoing training, and peer recognition. We are dedicated to fostering a Total Self culture—encouraging you to bring your authentic self to work. Our diverse, inclusive environment is built on respect and collaboration, making it a place where everyone feels they belong.

    Job Responsibilities:

    • Site Management & Monitoring: Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remotely). Ensure regulatory, ICH-GCP, GPP, and protocol compliance. Assess site performance and escalate issues when necessary, developing action plans for resolution.
    • Informed Consent & Patient Safety: Verify proper informed consent process and confidentiality of patient data. Assess site factors affecting patient safety, clinical data integrity, and resolve any protocol deviations or pharmacovigilance concerns.
    • Data Review & Compliance: Conduct Source Document Reviews and verify the accuracy of data entered into case report forms (CRFs). Resolve queries and ensure compliance with electronic data capture systems.
    • Investigational Product (IP) Management: Oversee IP inventory, reconciliation, and security. Ensure IP is dispensed and administered according to the protocol, addressing any issues with blinded or randomized data.
    • Documentation & Reporting: Review the Investigator Site File (ISF) for completeness and reconcile with the Trial Master File (TMF). Ensure archiving compliance with local regulations. Document site activities, track progress, and address action items.
    • Project Coordination: Understand project scope, budgets, and timelines. Manage site-level activities and communication to ensure that project objectives are met and targets are achieved. Adapt to changing priorities as necessary.
    • Collaboration & Training: Act as the primary liaison for site personnel. Ensure all assigned sites and team members are trained and compliant with project requirements. Attend Investigator Meetings, sponsor meetings, and participate in clinical training sessions.
    • Audit Readiness & Compliance: Ensure sites meet audit readiness standards and provide support for audit preparation and follow-up actions.
    • Real World Late Phase (RWLP) Support: Support the entire site lifecycle from identification to close-out. Contribute to chart abstraction, data collection, and collaborate with Sponsor affiliates, medical science liaisons, and local staff. Train junior staff as needed and identify out-of-scope activities to escalate to the Lead CRA/Project Manager.

    Qualifications:

    • Education: Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
    • Experience: At least 2 years as a Clinical Research Associate with solid knowledge of GCP, ICH guidelines, and regulatory requirements.
    • Skills: Strong computer skills and ability to adapt to new technologies. Excellent communication, presentation, and interpersonal skills.
    • Travel: Must be able to manage up to 75% travel.

    Get to Know Syneos Health

    Syneos Health has been instrumental in working on 94% of all Novel FDA-Approved Drugs and 95% of EMA Authorized Products. Over the past five years, we’ve collaborated on more than 200 studies, spanning 73,000 sites and involving over 675,000 trial patients.

    Join us today and be part of a highly competitive, ever-evolving industry where your contributions can truly make a difference.

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