27 days old

Sr. Clinical Research Associate

  • Job Code
JobId: 370868
JobTitle: Sr. Clinical Research Associate
Department: Clinical Affairs
Location: Somerset Davidson
Description: Job Summary:

Ensure clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements by engaging with assigned sites.
The Sr. CRA supports the day to day operations associated with the execution of clinical trials including the monitoring of multiple clinical trial sites and studies. The Sr. CRA is the primary contact with the study site and serves as the liaison between clinical investigators and Terumo. He \/ she is responsible for site training, regulatory document collection, tracking enrollment, and ensuring case report forms are accurate, complete and verifiable against source documents. The Sr. CRA is expected to contribute and\/or lead the development and improvement of company procedures, processes, and templates in support of TerumoÙs efforts towards continuous quality improvement. This role is also expected to perform as a mentor to junior associates performing similar tasks.
Job Details:
  • Lead development of study materials (e.g. clinical protocol, CRFs, ICF, training materials, monitoring plans, other study plans and study tools, etc.)
  • Lead study committees, such as DMC and\/or CEC, and manage core lab activities.
  • Performs all aspects of site management, including:
    • Site selection, start-up\/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices, applicable regulations, SOPs and work instructions.
    • Conduct contract negotiation with sites on study budget and facilitate legal review
    • Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
    • Administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
    • Manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution. 
    • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.
    • Develop and maintain study trackers and reports.
    • Evaluate the quality and integrity of study site practices related to the proper conduct of the study and adherence to applicable regulations. 
      • Support and assist in the resolution of quality or audit findings.
      • Execute assigned work efficiently and adhere to project timelines and financial goals.
      • May provide assistance to less experienced clinical staff, including demonstrating appropriate interactions with sites, documentation and other monitoring activities.
      • May present, and\/or assist in the development of materials for, study updates to study management and\/or other departments.
      • Frequent travel to sites, vendors, training, conferences, team meetings, etc. (up to 50%).
        • International travel may be required
        • Perform other duties and responsibilities as assigned.


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