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Remote Dir Clinical Research Scientist needs 5+ years pharma experience in clinical scientist/clinician/medical monitoring/CRA or related roles

Remote Dir Clinical Research Scientist requires:

Must have prior experience in Clinical Development or Clinical Research functional area
MS Degree in science or health-related field and extensive relevant experience required
MD or DO, or PhD or Pharm D preferred
Has comprehensive knowledge of the clinical research process and Good Clinical Practices from previous employment experience and/or education in the clinical research field
Psychiatry or Neurology TA area experience strongly preferred
Has ability to work independently with instruction primarily on unusual or complex problems
Has working knowledge of statistics, data analysis, and data interpretation
Has exceptional written and oral communication and cross-functional collaborative skills
Experience in in all aspects of clinical trials, GCP, and evaluation of adverse events and data review
Thorough knowledge of the investigational product(s), the protocol, applicable SOPs, GCP, data privacy laws and local regulatory requirements
Is proficient in MS Word, Excel, and PowerPoint
Must have prior experience in Clinical Development or Clinical Research functional area

Remote Dir Clinical Research Scientist duties:

Work within a matrix environment to proactively coordinate understanding of priorities and deliverables throughout study conduct
Provide clinical input for and participate in study set up and design including data collection tools, data analysis, eCRF design, edit checks, vendor database design plans, etc.
Review and provide input for the design of the Statistical Analysis Plan, TLFs, and the clinical data output
Study-level efficacy and safety data review and interpretation, including documentation and summarization of findings for Sr. Clinical Research or cross-functional staff and proper escalation of any identified issues
Clinical/medical review of site-level and subject-level data, including safety data, efficacy data, protocol deviations and coding
Lead and/or support the preparation of clinical/regulatory documents as required, such as protocols and protocol amendments, CSRs, Investigator’s brochure, and responses to health authorities
Answer clinical (safety & protocol) questions directly from sites or from the site monitor
Answer specific inclusion/exclusion criteria questions and participate in subject eligibility review
Conduct literature review and critical analysis as well as regulatory guidance review and summarization
Reference : Remote Dir Clinical Research Scientist, Pays $100/hr jobs

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Published at 14-04-2022
Viewed: 180 times