Clinical Scientist (Remote - Hematology)
Posted on: May 15, 2022
JOB TITLE: Clinical Scientist
COMPANY: Clinical-Stage Biotech - Autoimmune Diseases and
LOCATION: CA candidate preferred, Remote OK
We are looking to bring on a contract Clinical Scientist to be
responsible for the design and execution of assigned clinical trial
activities while working closely with clinical team members to
execute activities associated with trial conduct.
The company is based in San Francisco, but the position can be
fully remote and requires a 40hr/week commitment (must work PST).
This is a 6-month renewable contract with likelihood for
- Responsible for design and execution of assigned clinical trial
activities and works closely with clinical team members to execute
activities associated with trial conduct.
- May lead or support trial level activities for one or more trials
with the necessary supervision.
- Collaborate and liaise with external partners (e.g., KOLs).
- Seek out and enact best practices with instruction.
- Provide regular and timely updates to manager/management as
- Collaborate cross-functionally to develop Protocol and ICF
documents / amendments and present these to governance committee
and early clinical development team meetings as required.
- Conduct literature review.
- Develop site and CRA training materials and present these at SIVs
and Investigator meetings.
- Review clinical narratives.
- Collaborate cross-functionally to monitor clinical data for
- Contribute to the development of Data Review Plan in
collaboration with Data Management.
- Ensure CRF design adequately supports data collection in
alignment with the protocol in collaboration with Data
- Author/review clinical contributions to clinical study reports
(CSRs) and clinical portions of Regulatory Documents (e.g.,
Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB
responses and contribute to regulatory submission.)
- Submit clinical documents to TMF.
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar
scientific field preferred).
- Expectation of 2+ years of experience in clinical science,
clinical research, or equivalent, hematology and oncology prior
- Proficient knowledge of GCP/ICH, drug development process, study
design, statistics, clinical operations.
- Ability to understand assigned protocol(s) and their
- Knowledge and skills to support program-specific data review and
- Intermediate medical writing skills and medical terminology.
- Basic knowledge of the establishment and operation of data
monitoring committees, dose review teams, and independent response
Keywords: Meet, Raleigh , Clinical Scientist (Remote - Hematology), Healthcare , Raleigh, North Carolina
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