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Clinical Research Scientist | Pharmaceutical GMP Industry

People Make Us San Francisco ,CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Actual Job Title = Clinical Scientist (CS) - Contractor
Duration = One year from start date (the Early Clinical Development - Hematology/Oncology & Cellular Therapy dept has history of converting contractors to FTE depending on the fit)
Typical Daily Work Hours = 8am to 5pm (some flexibility in start/end times)
Weekend & OT work NOT required.
100% onsite work.

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
  1. Review of protocols & amendments; may include consolidation of feedback; may draft minor protocol amendments
  2. Review Informed Consent Forms (ICF); may author a global or regional ICF template
  3. 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).
  4. Support study committee(s) logistics (e.g., meetings, correspondence) and presentation developmentReview and validation of clinical study reports (CSRs); demonstrate basic understanding of the connection between the data and the CSR
  5. May assist in preparation of site and CRA training materials
  6. Conduct literature review as needed
  7. Preparation, storage, maintenance of clinical documents (TMF)
  8. 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

People Make Us

Why Work Here?

Competitive pay working under a highly professional company!

Address

San Francisco, CA
USA