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    Cra Ii

    Syneos Health
    3+ years
    Not Disclosed
    India
    10 Dec. 1, 2024
    Job Description
    Job Type: Full Time Education: 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

    The Clinical Research Associate II (CRA II) position at Syneos Health focuses on overseeing and ensuring the compliance of clinical trial sites with study protocols, regulations, and Good Clinical Practice (GCP) guidelines. This role involves both onsite and remote monitoring of clinical trials across a variety of therapeutic areas, including neurology, immunology, rare diseases, cardiovascular diseases (CVD), and oncology.

    Position Overview

    Location: Home-Based, India-Asia Pacific
    Updated: November 11, 2024
    Job ID: 24005945

    As a CRA II, you will play a vital role in the monitoring and management of clinical trial sites, ensuring the integrity and safety of the data collected and the proper implementation of study protocols.

    Key Responsibilities

    1. Site Management & Monitoring:

      • Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remote).
      • Ensure that sites comply with regulatory guidelines, GCP, and the study protocol.
      • Evaluate site performance and provide recommendations on corrective actions, if necessary.

    2. Documentation & Data Review:

      • Verify that informed consent is appropriately obtained and documented for all subjects.
      • Review source documents and medical records to ensure accuracy and compliance with the trial protocol.
      • Resolve queries related to data entry and ensure data integrity within required timelines.
      • Ensure investigator sites comply with electronic data capture requirements.

    3. Investigational Product (IP) Management:

      • Oversee IP inventory and ensure it is dispensed and administered according to the protocol.
      • Verify compliance with GCP, local regulations, and organizational procedures regarding the storage, labelling, and return of IP.

    4. Site File Management:

      • Review the Investigator Site File (ISF) for accuracy, timeliness, and completeness, ensuring proper archiving of essential documents.

    5. Audit & Compliance:

      • Support preparation for audits and ensure all necessary follow-up actions are completed.
      • Maintain a working knowledge of regulatory guidelines and SOPs, and ensure project teams are properly trained.

    6. Collaboration & Training:

      • Liaise with study site personnel, ensuring they are trained and compliant with study requirements.
      • Participate in Investigator Meetings and clinical training sessions.
      • May provide training and support to junior staff as needed.

    7. Real World Late Phase (RWL) Studies:

      • If involved in RWL studies, assist with site support from identification to close-out, and engage in chart abstraction and data collection activities.
      • Collaborate with local affiliates and medical science liaisons to ensure smooth study execution.

    Qualifications

    • Experience:
      • Minimum 3 years of experience in both onsite and remote clinical monitoring.
      • Experience in therapeutic areas such as neurology, immunology, rare diseases, CVD, or oncology is preferred.
    • Education:
      • Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.
    • Skills:
      • Strong knowledge of ICH/GCP guidelines and other applicable regulatory requirements.
      • Excellent communication, presentation, and interpersonal skills.
      • Good computer skills and ability to adapt to new technologies.
      • Ability to travel up to 75% for site visits.

    Why Syneos Health?

    • Culture:
      Syneos Health fosters a diverse and inclusive environment, where employees can be their authentic selves, and offers career development opportunities, recognition, and rewards.

    • Impact:
      Syneos Health has a proven track record of working with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, making a significant impact in the biopharmaceutical industry.

    Application Information

    This is an exciting opportunity for experienced CRAs to contribute to cutting-edge clinical trials. If you meet the qualifications and are passionate about making a difference in the healthcare industry, Syneos Health encourages you to apply.

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