Clinical Scientist (Remote - Hematology)

Company: Meet
Location: Raleigh
Posted on: May 15, 2022

Job Description:

JOB TITLE: Clinical Scientist
COMPANY: Clinical-Stage Biotech - Autoimmune Diseases and Oncology
TYPE: Contract
LOCATION: CA candidate preferred, Remote OK

Job Summary:
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 extension.

Position Summary/Objective
- 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.

Position Responsibilities
- 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 requested.
- 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 specific trends.
- 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 Management/Programming.
- 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 Requirements
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred).

Experience Requirements
- Expectation of 2+ years of experience in clinical science, clinical research, or equivalent, hematology and oncology prior experience preferred.
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
- Ability to understand assigned protocol(s) and their requirements.
- Knowledge and skills to support program-specific data review and trend identification.
- Intermediate medical writing skills and medical terminology.
- Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committee

Keywords: Meet, Raleigh , Clinical Scientist (Remote - Hematology), Healthcare , Raleigh, North Carolina