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Clinical Scientist / Research and Early Development

Brisbane, CA 94005

Posted: 02/07/2024 Job Number: 26271993 Pay Rate: 76.0-78.34 USD/Hour

Job Description

Position is onsite at either Princeton Pike, NJ, Madison, NJ or Brisbane, CA.
The pay ranges between $76 - $78.34 per hour.

Project Description:
  • The Early Development Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.
  • 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 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.

Required Skills:
  • 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.
  • 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 committees.
  • Basic planning/project management skills (develop short range plans that are realistic and effective).
  • Basic knowledge of disease area, compound, current clinical landscape.
  • Detail-oriented with commitment to quality.
  • Intermediate critical thinking and problem-solving skills.
  • Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities;ability to meet day-to-day challenges with confidence and professionalism).
  • Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.G., patient profiles, report generating tools).
  • Domestic and international travel may be required (approximately 10-20%).

This 12+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com


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Bridget Burns

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