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    Cra Ii Or Senior Cra

    Syneos Health
    2-8 years
    Not Disclosed
    Remote - Europe
    10 July 26, 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, 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: Clinical Research Associate II / Senior CRA

    Company: Syneos Health®

    Location: Home-Based, Anywhere in Turkey

    About Syneos Health:
    Syneos Health® is a premier biopharmaceutical solutions organization dedicated to accelerating customer success through innovative clinical, medical affairs, and commercial insights. With a focus on simplifying and streamlining our processes, we put both the customer and patient at the center of everything we do. Join our 29,000-strong team across 110 countries and experience why working here truly matters everywhere.

    Why Syneos Health?

    • Career Development: We prioritize your professional growth with career progression opportunities, supportive management, technical training, and a robust recognition program.
    • Inclusive Culture: Our Total Self culture fosters an environment where you can be your authentic self. Embracing diverse perspectives and backgrounds, we create a workplace where everyone feels they belong.
    • Innovative Environment: We are committed to continuous improvement, building a company where employees thrive and customers achieve their goals.

    Job Responsibilities:

    • Site Management: Conduct site qualification, initiation, interim monitoring, management, and close-out visits (both on-site and remotely). Ensure compliance with regulatory standards, ICH-GCP, and/or Good Pharmacoepidemiology Practice (GPP) guidelines. Evaluate site performance, address serious issues, and develop action plans.
    • Informed Consent: Verify proper execution and documentation of informed consent processes, safeguarding subject confidentiality and assessing safety and data integrity.
    • Clinical Monitoring:
      • Assess site processes and review source documents.
      • Ensure accuracy and completeness of clinical data in case report forms (CRFs).
      • Resolve queries and provide guidance to site staff.
      • Ensure compliance with electronic data capture requirements.
    • Investigational Product (IP) Management: Oversee IP inventory, reconciliation, and protocol compliance for dispensing and administration. Ensure proper labeling, importation, and handling of IP.
    • Documentation: Maintain and reconcile Investigator Site File (ISF) and Trial Master File (TMF). Ensure compliance with archiving requirements.
    • Reporting: Document activities, support recruitment, and manage tracking systems for observations and action items.
    • Project Management: Understand project scope, budgets, and timelines; manage site-level activities to meet project goals. Adapt to changing priorities as needed.
    • Site Liaison: Serve as the primary contact with study site personnel and ensure compliance with training and requirements.
    • Meeting Participation: Prepare for and attend Investigator and sponsor meetings, and participate in global clinical monitoring/project staff meetings.
    • Audit Readiness: Guide site and project-level audit preparations and follow-up actions. Maintain up-to-date knowledge of relevant guidelines and complete required training.

    Qualifications:

    • Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
    • Strong knowledge of Good Clinical Practice (GCP) and ICH Guidelines.
    • Proficiency in computer skills and adaptability to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage up to 75% travel regularly.

    Additional Information:

    Syneos Health offers a comprehensive benefits package, including health benefits (Medical, Dental, Vision), a 401k plan with company match, an Employee Stock Purchase Plan, performance-based bonuses, and flexible paid time off. The annual salary range for this position is $63,090 to $145,000, based on qualifications and experience. Syneos Health adheres to federal, state, and municipal regulations regarding paid sick time and COVID-19 vaccination policies.

    Application Details:

    If your experience doesn’t align perfectly with the job description, we still encourage you to apply. We value transferable skills and diverse backgrounds. Join our Talent Network to stay connected with additional career opportunities.

    #LI-KU1

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