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Senior Clinical Research Associate (SCRA)

The SCRA will support clinical trial management with the implementation and conduct of clinical trials.

Responsibilities:

  • Drive start-up activities at U.S. study sites
  • Provide site management and monitoring for assigned clinical trial(s) and ensure protocol requirements, regulatory guidelines, and study timelines are met
  • Support the management of monitoring activities at clinical trial sites to assure adherence to Good Clinical Practices (GCPs) and study protocols
  • Provides guidance with the development of the trial’s protocol, Informed Consent Form, CRFs, monitoring plan, site reference materials, and other study related materials
  • Conduct pre-study, study initiation, interim monitoring, and close out visits and completes associated monitoring visit reports and follow up letters to investigators
  • Assist with inspection-readiness activities for regulatory agencies.
  • Assist in the planning of and participates in investigator meetings.
  • May assist with the development and negotiation of site budgets
  • Travel required

Requirements:

  • Minimum BS / BA (science or health care field) or nursing degree
  • 6 or more years’ experience as a CRA or field monitor at in a pharma or CRO setting

Preferred Skills, Qualifications, or Technical Proficiencies:

  • Attention to detail and ability to prioritize tasks to meet critical deadlines
  • Excellent verbal and written communication skills
  • Able to collaborate effectively with the study team, cross-functional team members, and external partners
  • Knowledge of ICH/GCP and FDA regulations
  • Strong proficiency in Microsoft Office

If you are interested, please submit your resume by email to hr@corcept.com

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