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    Bilingual French Cra

    Icon Strategic Solutions
    3 years
    preferred by company
    Canada
    10 Nov. 23, 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, 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

    This job description outlines the role and responsibilities of a Senior Clinical Research Associate I (CRA I) at Syneos Health. The role primarily focuses on ensuring compliance with regulatory standards such as ICH-GCP, conducting site qualification, monitoring, and close-out visits. Key tasks include verifying the informed consent process, monitoring clinical data integrity, resolving queries, and ensuring proper handling of investigational products. The position also requires collaboration with site managers, the preparation of visit reports, and supporting training and audit readiness.

    Key Responsibilities:

    1. Compliance & Monitoring:

      • Ensure adherence to ICH-GCP, regulatory guidelines, and the study protocol.
      • Conduct site monitoring visits (both on-site and remotely), reviewing source documents, verifying case report form (CRF) accuracy, and assessing data integrity.
      • Ensure informed consent processes are correctly executed and documented.
      • Monitor investigational product (IP) inventory and ensure compliance with storage, labeling, and administration protocols.

    2. Communication & Collaboration:

      • Work closely with site personnel, escalating issues and ensuring proper follow-up.
      • Provide training and mentorship to junior CRAs.
      • Attend investigator meetings and sponsor meetings, ensuring proper communication between all parties.
      • Collaborate with the project team to meet study objectives, timelines, and deliverables.

    3. Reporting & Documentation:

      • Write visit reports, track observations, and document all monitoring activities per SOPs.
      • Ensure timely data entry and resolution of any outstanding issues or queries.
      • Manage project documentation, ensuring all required files are complete and up to date.

    4. Site Management & Problem Solving:

      • Identify and resolve site-specific issues and deviations from the protocol.
      • Support the recruitment and retention of subjects/patients, ensuring adherence to timelines and project objectives.
      • Manage site-related activities, such as training, delegation of duties, and auditing for compliance.

    Required Qualifications:

    • Education: Bachelor’s degree in a related field (life sciences, nursing) or equivalent experience.
    • Experience: At least 3 years of experience in clinical monitoring or as a CRA.
    • Technical Skills: Knowledge of ICH-GCP guidelines, experience with clinical data management tools (e.g., Siebel CTMS, eTMF, eISF), and familiarity with electronic data capture systems.
    • Languages: Bilingual (French and English) proficiency required.
    • Travel: Willingness to travel up to 75%, regionally for site visits.

    Preferred Qualifications:

    • Experience in Oncology: Experience with oncology clinical trials is a plus.
    • Centralized/Targeted Monitoring: Experience in centralized or risk-based monitoring methodologies is preferred.
    • Attention to Detail & Organizational Skills: Ability to handle multiple protocols and ensure accurate documentation and timely reporting.

    Behavioral Competencies:

    • Communication: Strong verbal and written communication skills for internal and external stakeholders.
    • Problem Solving: Ability to overcome barriers and suggest improvements in processes.
    • Adaptability: Demonstrated flexibility to adapt to changes in priorities or timelines.

    This position is ideal for an experienced clinical research professional who thrives in a dynamic, regulated environment, and is passionate about ensuring quality and compliance in clinical studies.

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