Clinical Trial Specialist

Job type:
Start date:
Real Staffing
South San Francisco
Published at:
flag_no USA
Project ID:

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The Clinical Trial Specialist (CTS) supports moderately complex clinical trial activities. The CTS works closely with the clinical trial team to ensure site related start-up through close-out activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's. The CTS assists with vendor oversight and management. Identifies issues in a timely manner and escalates to management as appropriate. The CTS may complete monitoring visit report review and/or perform on-site monitoring. The core duties and responsibilities of the CTS are delineated below.
  • Manages Site Essential Documents review during study start-up, maintenance and close-out period
  • Prepares study documents (i.e. consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy binder, etc.)
  • Ensures tracking of essential documents are received and filed in the CTMF, reviews site documents (including site-specific informed consent forms)for accuracy and follows up as needed
  • Ensures tracking of patient status throughout the study at investigative sites
  • Provides clinical team support with CTMF filing and management
  • Ensures quality of the data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues
  • May review and approve trip reports, track data query reports, site visit metrics, and overall site performance
  • May perform routine monitoring at limited clinical sites
  • May perform site initiation, routine monitoring and close-out visits at a limited # of clinical sites, as well as co-monitoring with local CRAs
  • Assists in the preparation of, and may present at investigator vendor meetings and workshops
  • Actively involved in the performance of study feasibility assessments
  • Adheres to study timelines, quality, and budget for assigned studies
  • Provides rapid action to address both internal and site QA findings from audits
  • May coordinate the activities from third party vendors including metrics, accruals, process planning, and implementation
  • Routinely participates in department and clinical trial team meetings and may participate in collaborative efforts (e.g. protocol development, CRO selection, departmental initiatives, etc.)

  • Bachelors' degree or higher
  • 4 years industry experience preferred, in a scientific or medical field, with at least 2 years working specifically on clinical trial coordination and site management
  • Previous Site monitoring experience
  • Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures
  • Basic knowledge of therapeutic area or disease
  • Understanding of study phases and general knowledge of how they apply to clinical development
  • Advanced knowledge of Word, Excel, and PowerPoint.
  • Knowledge of the principles and practices of computer applications in database management
  • High degree of customer focus towards internal and external stakeholders.
  • Strong interpersonal and collaboration skills.
  • Strong verbal and written communication skills required.
  • Able to handle multiple tasks and deadlines.
  • Ability to identify issues and take appropriate actions.
  • 10-30% travel may be required