Open Positions


« Back To All Positions

San Francisco Bay Area, CA

  • Senior Clinical Research Associate

    Sunnyvale, CA, US

    Summary:

    The Senior Clinical Research Associate is a in-house based position that manages clinical studies by effectively coordinating the activities of study coordinators and teams ensuring compliance with study protocols, all applicable regulations and overall clinical objectives.

    Responsibilities: 

    • Managing Study Master Files to assure quality of the documentation files and compliance with SOPs, GCP and ICH Guidelines.
    • Collecting contracts, requesting/collecting relevant investigator/site documentation (i.e. Regulatory Docs, FDF, CV/ML).
    • Develop, review and process core study documents thru document control document control process and relevant departmental processes, in support of study start-up and maintenance.
    • Assist study teams with study start-up (e.g site initiation visit preparation, product shipment, start of patient enrolment) and study conduct throughout the study.
    • Ensure all regulatory documents and study supplies are maintained during the lifecycle of assigned clinical trials.
    • Prepare and review of various study related tracking sheets to determine and report status of clinical trial documents (distribution, status, retrieval of such documents as protocol, IB, etc.)
    • Perform budget negotiations and/or interact with internal legal team, as needed.
    • Participate in the study budget process and invoice tracking for 3rd party CROs, Vendors, Consultants and Clinical Sites.
    • Act as primary liaison for assigned CROs and Vendors to convey project information, answer questions and resolve issues in accordance with relevant study procedures.
    • Comply with ICH/GCP guidelines, GDPR and patient data protection laws, applicable SOPs and Process Guidelines, and study requirements.
    • Attend Investigator Meetings and study-specific training for assigned trials.
    • Help mentor and develop new and junior team members.
    • Perform other duties as needed.

    Requirements:

    • Bachelor’s Degree required
    • 5+ years with clinical research experience at a medical device company.
    • Must have at least 2-3 years of experience with inspection readiness.
    • Have a strong attention to detail and ability to solve problems and clearly communicate issues.
    • Ability to take initiative, be adaptable, and strive in a dynamic environment.
    • Ability to work on multiple projects and multitask.
    • Ability to work independently and as a team member.
    • Positive and energetic attitude.
    • Be flexible to travel up to 10-15%.


« Back To All Positions