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    Cra Ii / Sr Cra I - Sponsor Dedicated

    Syneos Health
    1-8 years
    Not Disclosed
    Remote, USA
    10 Aug. 20, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

    About Us:

    Syneos Health® is a global leader in biopharmaceutical solutions, committed to accelerating customer success. We integrate clinical, medical affairs, and commercial insights to address today’s market realities. With 29,000 employees across 110 countries, we are driven by a passion to change lives and deliver therapies faster. Discover why working here matters everywhere.

    Why Syneos Health:

    We are dedicated to fostering the development of our people through career progression, supportive management, and technical and therapeutic training. Our Total Self culture promotes authenticity and unity, ensuring a work environment where everyone feels they belong. Join us to collaborate with innovative problem solvers and drive meaningful outcomes for our customers and patients.

    Job Responsibilities:

    • Site Management & Monitoring:

      • Conduct site qualification, initiation, interim monitoring, management, and close-out visits, both on-site and remotely, ensuring compliance with regulatory, ICH-GCP, GPP, and protocol guidelines.
      • Assess site processes and verify the accuracy and completeness of clinical data in case report forms (CRFs) through source document review.
      • Monitor site compliance with electronic data capture and investigational product (IP) handling, ensuring adherence to protocols and regulations.
      • Support subject/patient recruitment, retention, and awareness strategies.

    • Documentation & Reporting:

      • Maintain and reconcile the Investigator Site File (ISF) with the Trial Master File (TMF), ensuring accuracy and completeness.
      • Document site activities through confirmation letters, follow-up letters, trip reports, and other project documents as per SOPs and the Clinical Monitoring Plan/Site Management Plan.
      • Enter data into tracking systems to monitor site observations, status, and action items.

    • Collaboration & Training:

      • Act as the primary liaison with project site personnel or collaborate with Central Monitoring Associates.
      • Participate in Investigator Meetings, sponsor meetings, and clinical training sessions.
      • Provide guidance and mentorship to junior Clinical Research Associates (CRAs) and may lead training and sign-off visits.

    • Real World Late Phase (RWLP) Responsibilities:

      • Use local knowledge of treatment patterns, patient advocacy, and HCP associations to suggest potential sites.
      • Collaborate with the RWLP Regulatory team and develop country-level informed consent forms.
      • Support site operations throughout the study lifecycle, from identification to close-out, and contribute to chart abstraction and data collection activities.

    Qualifications:

    • Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.
    • Strong knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other applicable regulatory requirements.
    • Proficiency with computers and an ability to embrace new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Critical thinking skills and the ability to manage shifting priorities to meet project goals and timelines.
    • Ability to manage travel requirements up to 75%.

    Additional Information:

    • Syneos Health is committed to equal opportunity employment and complies with all applicable laws regarding non-discrimination. We encourage candidates with transferable skills to apply.
    • We offer a comprehensive benefits package including health benefits, a 401k company match, an Employee Stock Purchase Plan, and flexible paid time off.
    • The annual base salary for this role ranges from $72,540 to $145,000, depending on qualifications, skills, and experience.

    Join Our Team:

    At Syneos Health, your work makes a difference. If you’re ready to challenge the status quo in a dynamic and competitive environment, we encourage you to apply. Not ready to apply? Join our Talent Network to stay connected with future opportunities.

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