Job Details

  • Title: Clinical Project Associate
  • Code: RCI-08090
  • Location: Foster City California (CA) 94404
  • Posted Date: 03/27/2020
  • Duration: 18 Months
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  Job Description

  • Acquires and utilizes knowledge of clinical trial design to develop specific study concept sheets and protocols
  • Participates in protocol review discussions concerning scientific and procedural aspects of study design
  • Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with appropriate guidance and supervision
  • Contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans
  • Addresses questions regarding scientific and related procedural issues from Investigators
  • Contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations
  • Assists in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs
  • Supports priorities within functional area
  • Anticipates moderately complex obstacles within a clinical study and with guidance implements solutions
  • May be asked to coordinate teams and provide direction
  • May lead two or more specific components of departmental strategic initiatives
  • Must be able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development
  • Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies
  • May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems