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Zogenix

Sr. Clinical Research Associate

400 Clinical Development – San Francisco, California
Department 400 Clinical Development
Employment Type Temp
Minimum Experience Experienced

Zogenix is currently seeking experienced Senior Clinical Research Associate to support the management of clinical study activities for global pediatric epilepsy program. The Clinical Operations department is growing due to the initiation of the Dravet Syndrome Phase III Program and this position is key to study start-up, conduct, reporting and monitoring oversight of these clinical trials.  The successful candidate will apply strong fundamental skills in clinical operations with excellent knowledge of FDA and EMA regulations, GCP and ICH guidelines to meet critical business objectives.  Strong clinical trial management experience with an emphasis on prior experience managing Phase III CRO’s and related vendors is strongly preferred.

Responsibilities

  • Responsible for monitoring oversight activities of 3rd party CRO.  
  • Assist with review and development of case report forms, study newsletters and participate in user acceptance testing for IxRS and eCRFs.
  • Assist in the development of CRA training, site training or investigator meeting materials;
  • Assist in development of monitoring plans, study plans, informed consents, assents and coordinating study reports.
  • Assist with specific study start up activities 
  • Travel up to 70% 

Requirements

  • Bachelor’s degree in a relevant scientific discipline or equivalent. 3-5 years of relevant clinical trial support or monitoring experience in the pharmaceutical industry or equivalent;
  • Experience interacting with CROs in the management of Global Phase 3 studies
  • Experience managing third party vendors such as central Lab, IXRS and ePRO.
  • Detail oriented; strong program management skills with excellent follow up
  • Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
  • Demonstrated ability to work independently and in a team environment.

Preferred Qualifications

  • Familiarity with pediatric informed consents and assents.
  • Experience with western Europe, Australia or Asia a plus

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  • Location
    San Francisco, California
  • Department
    400 Clinical Development
  • Employment Type
    Temp
  • Minimum Experience
    Experienced
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