Directory of Consultants
Bay Area Biomedical Consultants Network (BABCN)
Name and Educational Degree(s) Rogers, Julie, BS
Certifications CRA

University of California at Santa Barbara

Bachelor of Science in Physiology and Cell Biology

Business Address 50 Carlyle Court
Danville, CA 94506
Contact information
Email address:

Providing a wide range of routine clinical trial support either in house or as a regional monitor. 


  • Twelve years drug development experience from study start-up through close-out
  • Knowledge of GCP/ICH guidelines and the CFR
  • Extensive clinical trial monitoring experience in multiple therapeutic areas
  • Experience with electronic data capture (EDC)


  • Contributed to the success of three pivotal Phase III trials that subsequently received FDA approval.
  • Exceeded timelines for opening new sites, enrollment, query resolution and/or data lock on six separate occasions.
  • Successfully executed the launch of three trials that utilized over 220 sites.
  • Managed seven of the highest enrolling sites on four separate trials.

In House:  Total experience encompasses eight drug development programs consisting of twenty-one studies inclusive of all phases of human trials. 

Specifics include: assisting with the selection of CROs and other third party vendors, identifying new sites and investigators, facilitating negotiations of Clinical Trial Agreements and budgets, issuing payments to investigators, writing study documents including but not limited to; protocols, ICF templates, CRF design and completion guidelines, visit report templates, laboratory manuals, source document worksheets, monitoring worksheets, and monitoring plans, auditing and maintaining complete and accurate clinical trial master files, managing field CRAs, tracking study progress including, patient enrollment, regulatory documents, drug supply, and study supplies.  Cross functionally working with Data Management in reviewing data listings and generating manual queries to sites based on findings and assisting with the generation of edit checks based on protocol parameters

Regional Monitoring:  Total experience includes successfully managing 43 sites in eight therapeutic areas.  Conducted countless qualification, initiation, routine, and close out visits, in accordance with protocols, GCP/ICH Guidelines, and SOPs.

Specifics include:

  • Managing and training site personnel on protocol requirements, proper source documentation, and case report form completion.
  • Identifying and reconciling Adverse and Serious Adverse Events.
  • Managing trials by reviewing and reporting on the following: site enrollment and termination, monitoring visits, protocol deviation/exceptions, drug accountability, study supplies, and laboratory abnormalities.
  • Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, identifying and resolving ongoing data issues.
  • Performing drug accountability.
  • Maintaining consistent contact with the study centers, investigators, coordinators, client personnel, and other individuals as necessary.
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