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Clinical Scientist

Trenton, NJ 08648

Posted: 02/26/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 600139 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 70-80.03/hr **salary will be commensurate with experience 

Job Description:


Research and Early Development

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
Requirements:
  • 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%)
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About Trenton, NJ

Ready to take your career to the next level? Explore our job opportunities in the vibrant Trenton, New Jersey area! Nestled in the heart of the Garden State, Trenton offers a perfect blend of history, culture, and growth opportunities. From the stunning views along the Delaware River to the iconic Trenton War Memorial and historic State House, this city is rich in charm and history. Indulge in the local flavors of tomato pies and pork roll sandwiches, then immerse yourself in the thriving arts scene with visits to The Trenton City Museum at Ellarslie Mansion or catch a show at the Passage Theatre Company. With easy access to nearby Philadelphia and New York City, endless outdoor adventures in Mercer County Park, and the excitement of catching a game at CURE Insurance Arena supporting the Trenton Thunder, there's no shortage of reasons to consider Trenton for your next career move. Explore our job listings today and set your sights on a bright future in this dynamic region!

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