Regional CRA

San Jose, CA 95110

Posted: 10/08/2019 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 16542

Our Client in the SF Bay Area is looking to hire a Regional CRA for their team in a full-time permanent role!

Regional CRA 

ESSENTIAL DUTIES
  • Monitoring clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit  This may include the following site visits: qualification, initiation, interim, and close out
  • Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
  • Managing, preparing, sending, tracking, and returning investigational supplies at individual sites
  • Monitoring and documenting investigational product dispensing, inventory, and reconciliation
  • Monitoring and documenting laboratory sample storage and shipment
  • Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviation/exceptions, serious adverse events and laboratory abnormalities
  • Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues
  • Reviewing data queries and listings, and working with the study centers to resolve data discrepancies
  • Reviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issues
  • Maintaining complete and accurate study files and reviewing files to ensure all appropriate documentation is present
  • Maintaining consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials
  • Other tasks or responsibilities as assigned

OTHER QUALIFICATIONS 
  • Attention to detail
  • Flexibility with changing priorities
  • Excellent organizational skills
  • Ability to efficiently perform and prioritize multiple tasks
  • Ability to identify and take initiative to solve logistical problems
  • Effective verbal and written communication skills
  • Ability to work effectively both independently and on a diverse team
  • Familiarity with medical and pharmaceutical industry, and related terminology and practices
  • Appropriate knowledge of FDA regulations and their practical implementation
  • General computer skills (PC based) with proficiency in Microsoft Word, Excel, and Outlook
  • Ability to work efficiently on the computer, including document retrieval, review, and tracking
  • Ability to travel, including air travel, on notice as short as 24 hours, maintaining efficient and effective travel schedules
  • Must have a valid driver' s license, a good driving record, and up-to-date car insurance

EDUCATION AND/OR EXPERIENCE
  • RN or Bachelor and/or advanced degree in biological sciences or related field
  • Equivalent combination of relevant experience, education, or training and previous CRA  experience
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