Senior Clinical Research Associate

San Francisco  ‐ Onsite
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Keywords

Description

Roles and Responsibilities:
  • Assist in managing all aspects of clinical trials to ensure that studies are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
  • Develop and review informed consent forms, case report forms, study anuals, and other clinical trial materials
  • Assist in the evaluation and management of CROs and other vendors and systems. Negotiate and manage contracts/budgets with CROs and other vendors
  • Assist with creation of study specific tools and manuals to ensure timeliness, standardization and control of data quality
  • Review and provide input on regulatory documents and Clinical Trial Application documents
  • Perform site qualification, initiation, interim monitoring and close-out visits as needed. Perform co-monitoring visits/Sponsor Oversight Visits as required/requested
  • Plan, coordinate and present at Investigator Meetings and CRA Training meetings as requested
  • Support internal and regulatory audits of clinical trial sites and vendors and assist with resolution of audit findings


Requirements:
  • Bachelor's degree in a scientific discipline or health-related field
  • Minimum of 5 years clinical research experience and at least 3 years experience as a CRA in a biopharmaceutical company or CRO
  • Strong Knowledge of FDA regulatory requirements and ICH/GCP guidelines
  • Demonstrated proficiency in implementing, monitoring and management of clinical trials, from start-up to close-out. Experience with working on global trials a plus
  • Previous experience with Global oncology clinical trials is strongly preferred (Ovarian experience helpful)
  • Willingness to travel as necessary, consistent with project needs ***


To find out more about Real please visit www.realstaffing.com
Start date
09/2013
Duration
Temp to Hire
From
Real Staffing
Published at
21.09.2013
Project ID:
602504
Contract type
Freelance
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