Job Details

  • Title: Scientist - Clinical Research
  • Code: RCI-9482
  • Location: San Francisco California (CA) 94158
  • Posted Date: 05/28/2020
  • Duration: 12 Months
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  Job Description

The Clinical Scientist, Early Clinical Development - Hematology/Oncology & Cellular Therapy, contributes to the efforts of Early Development clinical trials from a clinical science perspective.

Summary/Scope: The CS, Contractor will work closely with clinical team members and will assist with activities associated with the conduct of a clinical study.

 

Responsibilities will include, but are not limited to, the following:

  • Support assigned study level tasks with supervision by lead Clinical Scientist such as
    • Review of protocols & amendments; may include consolidation of feedback; may draft minor protocol amendments
    • Review Informed Consent Forms (ICF); may author a global or regional ICF template
    • Clinical review of study data (conduct clinical data review, communicate as necessary to resolve data queries, draft/update/review data review plans, support study physician in data review (generation of reports, action plans, trend identification).
    • Support study committee(s) logistics (e.g., meetings, correspondence) and presentation development
    • Review and validation of clinical study reports (CSRs); demonstrate basic understanding of the connection between the data and the CSR
    • May assist in preparation of site and CRA training materials
    • Conduct literature review as needed
    • Preparation, storage, maintenance of clinical documents (TMF)
    • Support study start-up/conduct/close-out activities as applicable
  • Demonstrate in-depth understanding of the assigned protocol and protocol requirements
  • Prioritize work assignments in collaboration with manager and protocol lead CS
  • Attend study team meetings as requested
  • Interface with others for scientific and functional guidance
  • Identify & escalate current/active issues
  • Enact best practices with instruction
  • Actively seek and receive coaching/mentoring
  • Provide regular and timely updates to manager

 

Skills/Knowledge Required:

  • Entry level position with expectation of 2+ years of experience in clinical science, clinical research, or equivalent
  • Awareness of GCP/ICH, drug development process, study design, statistics
  • Excellent verbal, written, communication, and interpersonal skills
  • Detail-oriented
  • Entry level knowledge of CRFs, CRF guidelines, study endpoints and skills to support data review
  • Basic knowledge of disease area
  • Entry level medical writing skills and medical terminology
  • Entry critical thinking & problem solving skills
  • Commitment to Quality
  • Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
  • Proficient skills in Microsoft Word/Excel/PowerPoint and data review tools