Job Details

  • Title: Clinical Trials Management Associate
  • Code: RCI-08003
  • Location: Foster City California (CA) 94404
  • Posted Date: 02/28/2020
  • Duration: 6 Months
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  Job Description

Must meet all requirements for Clinical Trials Management Associate position and have demonstrated proficiency in all relevant areas.

  • With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required
  • Assures site compliance with the routine protocol and regulatory requirements and quality of data
  • Assists in the setting and updating of study timelines
  • Assists in CRO or vendor selection
  • With guidance from supervisor coordinates CROs or vendors
  • Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans
  • Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies
  • Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams
  • May participate in abstract presentations, oral presentations and manuscript development
  • Interfaces with individuals in other functional areas to address routine study issues
  • May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants
  • Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives
Qualifications
  • Excellent verbal, written, interpersonal and presentation skills are required
  • Working knowledge and experience with Word, PowerPoint and Excel
  • Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials
  • Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures
  • Ability to develop tools and processes that increase measured efficiencies of the project
  • Must be able to anticipate obstacles and proactively develop solutions to achieve project goals
  • Must have a general understanding of functional issues and routine project goals from an organizational perspective
  • Travel is required