Job title: Clinical Research Scientist
Company: Orbis Clinical
Job description: The Clinical Research Scientist (CRS) will support and work predominately with the Clinical Trial/Indication Lead(s) and Medical Monitor(s) for assigned protocols and/or projects, partnering with vendors and cross functional teams. The CRS will provide clinical and scientific support to clinical development and operations, regulatory, medical affairs, drug safety, and quality assurance teams, as well as overall program support ensuring the adherence to all standard operating procedures (SOPs)Participate in cross functional teams to develop and implement clinical studies within clinical program(s). Responsibilities include but are not limited to:
- Collaborate with internal teams, contract research organizations (CROs), and external vendors to prepare, review and finalize clinical study documents and plans
- Contribute to scientific and operational aspects and stages of the protocol development and study execution, from study design planning through final reporting of results
- Provide scientific input and review of clinical study data, support in assessing medical monitoring reports, study integrity/conduct, and study oversight
- Support preparation of abstracts, manuscripts, presentations, and materials for meetings as it related to the protocol(s) and program
- Provide protocol level scientific review of information to support the development and updates for regulatory documents (i.e., IND submissions, IND Annual Updates, DSUR, and Investigator Brochures)
- Support enrollment projections and assist with the development and implementation of subject recruitment and retention strategies
Provide scientific support to the study teams, including:
- Collaborate with team members in the review and development of Data Management activities including eCRFs, edit checks, report development, and database lock processes
- Participate in activities related to data review, database lock, medical monitoring, and query resolution for the protocol
- Work with other clinical scientist(s), medical monitors, and drug safety to provide support and scientific review of safety data
- Provide scientific review of study plans
Support corporate objectives:
- Development, review, and revision of departmental and corporate SOPs and processes
- Support regulatory activities at the protocol level to develop, prepare and respond to regulatory authorities
Expected salary:
Location: Bridgewater, NJ
Job date: Sat, 15 Feb 2025 23:44:46 GMT
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