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Clinical Scientist (CS) - Contractor - Pharma
Ref No.: 20-00465
Location: Summit, New Jersey
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.
  • The CS, Contractor will work closely with clinical team members and will assist with activities associated with the conduct of a clinical study.
  • 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.

Qualifications:
  • 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