Sr. Clinical Monitor

South San Francisco, CA 94080

Posted: 05/01/2019 Employment Type: Contract-to-Hire Industry: Clinical & Scientific Job Number: 15589

Sr. Clinical Monitor

Commutable to Costa Mesa, CA or SF Bay Area (in SSF office 1-2 times per week)

50% Travel Requirement 

 
  • 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
  • Bachelors and/or advanced degree in biological sciences or related field
  • Equivalent combination of relevant experience, education, and previous 5yrs CRA monitoring experience.

 

Jesse Ashworth

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