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    Cra Ii / Senior Cra - Sponsor Dedicated - Bulgaria

    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 / Senior Clinical Research Associate – Syneos Health

    Location: Office-Based, Bulgaria

    Syneos Health® is a global leader in biopharmaceutical solutions, driven by a mission to accelerate customer success and deliver life-changing therapies. We work across clinical development, medical affairs, and commercial solutions, with a focus on simplifying processes and making a difference in healthcare outcomes. We are currently seeking a Clinical Research Associate II / Senior Clinical Research Associate to join our team and play a pivotal role in advancing clinical trials.

    Job Responsibilities:

    • Site Management: Perform site qualification, initiation, monitoring, and close-out visits, either on-site or remotely, ensuring compliance with regulatory requirements, ICH-GCP, and study protocols. Identify and escalate serious issues, and develop corrective action plans.
    • Informed Consent & Safety: Ensure proper informed consent documentation and safeguard patient confidentiality. Monitor and assess patient safety, including protocol deviations and pharmacovigilance concerns.
    • Data Management: Conduct source document reviews, verify clinical data accuracy in case report forms (CRF), resolve queries, and ensure data entry compliance with electronic data capture requirements.
    • Investigational Product (IP) Management: Oversee IP inventory, reconciliation, and storage. Ensure IP is dispensed and administered as per protocol, addressing any risks related to blinded or randomized information.
    • Documentation & Reporting: Review and maintain Investigator Site Files (ISF), ensuring consistency with Trial Master Files (TMF). Document activities including trip reports, follow-up letters, and communication logs.
    • Project Coordination: Manage site-level activities to ensure alignment with project timelines, scope, and budget. Communicate with site personnel and project teams to meet study objectives.
    • Audit Readiness: Support site and project compliance with audit standards and assist in preparing for audits.
    • Real-World Late Phase: For late-phase studies, provide site support from identification to close-out, conduct chart abstraction and data collection, and collaborate with local medical teams.

    Qualifications:

    • Education: Bachelor’s degree or RN in a related field or equivalent combination of education and experience.
    • Experience: Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and other regulatory requirements. Demonstrated ability to manage clinical trials effectively.
    • Skills: Excellent communication, interpersonal, and presentation skills. Strong computer skills and ability to learn new technologies. Ability to travel up to 75% as required.

    Why Syneos Health?

    At Syneos Health, we focus on creating a culture where you can be your authentic self. We prioritize career development, offering comprehensive training, mentoring, and progression opportunities. As part of a global team of over 29,000 employees, you’ll work alongside passionate professionals who are dedicated to delivering innovative solutions.

    If you're ready to make an impact, join us at Syneos Health and be a part of a team that's changing lives.

    Apply Today!

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