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    Sponsor Dedicated Cra Ii - Home Based Portugal

    Syneos Health
    2+ years
    Not Disclosed
    Portugal
    10 Nov. 23, 2024
    Job Description
    Job Type: Remote Education: RN/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    Job Title: Sponsor Dedicated Clinical Research Associate II

    Location: Home-Based, Portugal
    Company: Syneos Health

    About Syneos Health

    Syneos Health® is a global biopharmaceutical solutions organization dedicated to accelerating customer success. By integrating clinical, medical, and commercial expertise, we address modern market realities to deliver transformative outcomes.

    With 29,000 employees across 110 countries, our Clinical Development model places patients and customers at the center, streamlining work processes to improve efficiency.

    Why Join Syneos Health?

    • Career Development: Opportunities for growth, training, and progression.
    • Supportive Culture: Engaged line management, peer recognition, and total rewards programs.
    • Inclusive Environment: Total Self Culture fosters authenticity, diversity, and belonging.
    • Global Impact: Be part of innovative research that makes a difference in patients' lives.

    Job Responsibilities

    Site Management & Monitoring

    • Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remotely).
    • Ensure compliance with regulatory guidelines (ICH-GCP/Good Pharmacoepidemiology Practice) and protocols.
    • Evaluate site performance and recommend site-specific actions, escalating issues as needed.
    • Verify informed consent processes and assess factors affecting patient safety and data integrity.

    Clinical Data Oversight

    • Perform Source Document Review (SDR) of site documents and medical records.
    • Ensure clinical data entered in the case report form (CRF) is accurate and complete.
    • Resolve data queries both remotely and on-site, guiding site staff to meet deadlines.
    • Verify site compliance with electronic data capture (EDC) requirements.

    Investigational Product (IP) Management

    • Manage IP inventory, storage, and reconciliation to ensure compliance with protocols and regulations.
    • Verify proper dispensing and administration of IP, identifying risks associated with blinded or randomized studies.

    Documentation & Compliance

    • Maintain and reconcile the Investigator Site File (ISF) and Trial Master File (TMF).
    • Ensure proper archiving of essential documents in accordance with local regulations.
    • Document activities in confirmation letters, trip reports, and communication logs as per SOPs.

    Collaboration & Audit Readiness

    • Act as a liaison with study site personnel and project teams.
    • Attend Investigator Meetings and sponsor face-to-face meetings.
    • Guide site teams on audit readiness and support audit preparation.

    Real-World Late Phase (RWLP) Responsibilities

    • Provide site support throughout the study lifecycle, from identification to close-out.
    • Collaborate with local Sponsor affiliates, medical science liaisons, and country staff.
    • Conduct chart abstraction activities and data collection.
    • Identify and propose potential sites based on local treatment patterns and HCP networks.

    Qualifications

    Education & Experience

    • Bachelor’s degree or RN in a related field, or equivalent education and experience.
    • Minimum of 2 years’ experience as a Clinical Research Associate.

    Skills & Knowledge

    • Strong understanding of ICH-GCP Guidelines and applicable regulatory requirements.
    • Proficiency in computer systems and ability to adapt to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage frequent travel, up to 75%.

    About Syneos Health

    • Supported 94% of FDA-approved drugs and 95% of EMA-authorized products in the last 5 years.
    • Conducted over 200 studies across 73,000 sites and engaged 675,000+ trial participants.
    • Foster a collaborative, innovative environment to challenge the status quo and achieve meaningful impact.

    Additional Information

    • Tasks and responsibilities listed are not exhaustive and may vary based on company needs.
    • Equivalent education, skills, and experience will be considered.
    • Syneos Health complies with all local regulations, including the EU Equality Directive and the ADA, offering reasonable accommodations as required.

    Learn more at Syneos Health.

     

     

     

     

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