Clinical Research Associate II


Summary: The Clinical Research Associate II role supports the day to day operations associated with the execution of clinical trials and ensures the overall quality of our clinical trials by monitoring study data and managing site adherence to the protocol, GCP, all applicable regulations and related study documents.

Essential Duties: 

In this position, you will be responsible for the following:

  • Support all facets of clinical studies including investigator recruitment, qualification, investigational plan development, case report form development, IRB approval, study initiation and monitoring
  • Works closely with site personnel as well as other department members and contractors to ensure protocol and procedure compliance; monitors case report forms, study logs, and data; identify and resolve discrepancies; and recommends corrective and preventive action in a timely manner
  • Perform monitoring visits: qualify potential investigative sites, train and initiate investigative sites, conduct routine monitoring visits and close out visits
  • Review case report forms to ensure data compliance
  • Assist with managing regional monitors, core laboratories and other contractors
  • Proactively identify issues which may interfere with study progress and implement strategies to resolve issues
  • Verify appropriate reporting and documentation of adverse events and protocol deviations per protocol requirements

Experience, Knowledge and Skills Required:

  • Requires a BA/BS or RN degree or equivalent
  • 4-5 years’ experience as a CRA at a medical device company with field monitoring experience
  • Knowledge of clinical trial methodology relating to the monitoring of clinical trials, GCP, FDA
  • Experience with EDC system preferred
  • Knowledge of international regulations and ethics committees preferred
  • Ability to communicate well with the clinical sites and personnel

Travel:

  • Travel will be required about 40% of the time

Interested candidates should submit their resume to humanresources@silkroadmed.com. Please list the region and position you are applying for in the subject line of the email.

Join us!

  • AP140.A
    ©2018 Silk Road Medical

  • 735 North Pastoria Avenue,
    Sunnyvale, CA 94085

    phone: 855.410.TCAR (8227)
    local phone: 408.720.9002
    fax: 408.720.9013