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    Sr Cra Ii (Sponsor Dedicated) Working Experience With Mauritius

    Syneos Health
    3+ years
    Not Disclosed
    South Africa
    10 Jan. 22, 2025
    Job Description
    Job Type: Home Based Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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: Senior Clinical Research Associate II (Sponsor Dedicated) – Experience with Mauritius
    Location: South Africa (Home-Based)
    Job ID: 25001310
    Updated: January 20, 2025

    Company Overview:

    Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We deliver clinical, medical affairs, and commercial insights to address modern market realities, prioritizing patients and customers in every aspect of our work. We aim to simplify processes and create a flexible and efficient clinical development environment.

    Why Syneos Health:

    • Career Development: We offer extensive opportunities for career growth through technical and therapeutic training, mentorship, and a rewards program.
    • Inclusive Culture: Our Total Self culture encourages individuality and diversity, creating a welcoming global community.
    • Collaboration: We focus on fostering diverse thoughts and perspectives to build a company where everyone feels they belong.

    Position Overview:

    The Senior Clinical Research Associate II (CRA II) is responsible for overseeing site qualification, initiation, monitoring, and close-out visits for clinical trials. This position will focus on maintaining protocol compliance and ICH-GCP guidelines, and ensuring the integrity of clinical trial data. The CRA II will work closely with site staff and project teams to address issues and implement action plans for successful study execution.

    Key Responsibilities:

    • Site Management:

      • Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remote).
      • Ensure compliance with regulatory requirements, ICH-GCP guidelines, and study protocols.
      • Assess site performance and communicate/escalate issues to the project team.

    • Clinical Data & Documentation:

      • Review source documents and medical records to verify accurate and complete data entry in Case Report Forms (CRFs).
      • Address and resolve queries with site staff and maintain proper documentation.
      • Ensure Investigator Site Files (ISF) are complete and in compliance with regulatory requirements.
      • Track and document project activities, including follow-up letters, trip reports, and action items.

    • Investigational Product (IP) Management:

      • Perform IP inventory reconciliation, storage reviews, and verify the correct dispensing and administration of IP.
      • Ensure appropriate handling and labeling of blinded or randomized IP.

    • Training & Leadership:

      • Mentor and train junior CRAs and support site-level recruitment, retention, and awareness strategies.
      • Participate in Investigator Meetings, sponsor meetings, and lead or assist in training sessions.
      • Support audit readiness and assist in audit preparation and follow-up actions.

    • Project Coordination:

      • Manage site-level activities and communications to ensure the achievement of project objectives and timelines.
      • Adapt to changing priorities and drive operational efficiencies within clinical studies.

    • Real World Late Phase (RWLP) Responsibilities:

      • Support site activities from identification to close-out, including chart abstraction and data collection.
      • Collaborate with medical science liaisons and local country staff to build relationships and streamline operations.
      • Participate in business development proposals, bid defense meetings, and provide input into Requests for Proposals (RFPs).

    Qualifications:

    • Education: Bachelor’s degree or RN in a related field, or an equivalent combination of education and experience.

    • Experience:

      • In-depth knowledge of Good Clinical Practice (GCP), ICH Guidelines, and relevant regulations.
      • Previous experience as a Clinical Research Associate or equivalent with clinical trial experience.
      • Experience working in clinical trials, particularly in regions such as Mauritius.

    • Skills:

      • Proficient in computer skills and embracing new technologies.
      • Strong communication, presentation, and interpersonal skills.
      • Critical thinking abilities for managing complex issues.

    • Travel: Ability to travel up to 75% of the time.

    About Syneos Health:

    Syneos Health has supported 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products. With over 200 studies conducted across 73,000 sites and more than 675,000 trial patients, we are a leading partner in clinical development.

    Additional Information:

    • Duties & Responsibilities: The tasks mentioned above are not exhaustive, and additional duties may be assigned at the company's discretion.
    • Equal Opportunity Employer: Syneos Health is an equal opportunity employer, committed to diversity and inclusion.

    Apply Now: [Application Link]
    Join Our Talent Network: Stay connected for future opportunities.

    Syneos Health is committed to compliance with the Americans with Disabilities Act (ADA), offering reasonable accommodations as needed to assist employees in performing their job functions.

     

     

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