Immediate Need for Clinical Scientist in San Francisco, CA

[shankar prasad]

Hi,

We have an immediate need for Clinical Scientist in CA.  Please reply back with your resume if you are comfortable moving forward to sha...@sourceconsult.net or call 508-417-8385.

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

Regards,

Shankar

Source Consulting

508-417-8385

sha...@sourceconsult.net

[shankar prasad]