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    Sponsor Dedicated Cra Ii - Home Based Portugal

    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

    Sponsor Dedicated Clinical Research Associate II – Home-Based, Portugal

    Location: Home-Based, Portugal

    Syneos Health® is a leading biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical, and commercial insights into meaningful outcomes. Our Clinical Development model places the customer and the patient at the heart of everything we do, simplifying and streamlining processes to deliver innovative therapies. As part of a dynamic team, we are looking for a Sponsor Dedicated Clinical Research Associate II to contribute to the success of clinical trials in Portugal.

    Job Responsibilities:

    • Site Management & Monitoring: Lead site qualification, initiation, monitoring, and close-out visits (on-site or remote) ensuring compliance with regulatory standards, ICH-GCP, GPP, and study protocols. Assess site performance and escalate serious issues, recommending corrective actions.
    • Informed Consent & Safety: Ensure informed consent is obtained and documented appropriately. Protect patient confidentiality and assess safety concerns, including protocol deviations, violations, and pharmacovigilance issues.
    • Data Review & Compliance: Perform Source Document Review, verify data accuracy in case report forms (CRF), and resolve data queries in line with project timelines. Ensure compliance with electronic data capture requirements and assist with data review and capture processes.
    • Investigational Product (IP) Management: Oversee IP inventory, reconciliation, and storage, ensuring proper dispensation and adherence to protocol. Address risks associated with randomized or blinded IP information.
    • Documentation & Reporting: Maintain Investigator Site File (ISF) accuracy and reconcile it with Trial Master File (TMF). Ensure adherence to document archiving requirements. Document site visits and project activities using confirmation letters, trip reports, and communication logs.
    • Project Coordination: Manage site-level activities, ensuring alignment with project timelines, budgets, and objectives. Effectively communicate with site personnel and project teams to meet deliverables and targets.
    • Audit Readiness: Assist with site and project-level compliance, ensuring readiness for audits and supporting follow-up actions as necessary.
    • Real-World Late Phase (For Applicable Projects): Support sites from identification through close-out, including chart abstraction and data collection. Collaborate with local teams and affiliates, and identify potential sites based on local healthcare knowledge.

    Qualifications:

    • Education: Bachelor’s degree or RN in a related field, or equivalent experience.
    • Experience: At least 2 years of experience as a Clinical Research Associate, with a solid understanding of GCP, ICH Guidelines, and regulatory requirements.
    • Skills: Strong computer proficiency, ability to adopt new technologies, and excellent communication, presentation, and interpersonal skills.
    • Travel: Ability to manage required travel of up to 75% regularly.

    Why Syneos Health?

    Syneos Health is dedicated to fostering a diverse, inclusive, and collaborative workplace. We offer career development, technical and therapeutic training, and a supportive environment where employees can thrive. With over 29,000 employees across 110 countries, we work together to change lives and accelerate the delivery of vital therapies.

    Apply Today and become part of a team that is shaping the future of healthcare.

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