Scientist - Clinical Research jobs in Mount Vernon, NY

Scientist - Clinical Research assumes lead role in various clinical research projects. Proposes, plans, organizes and executes experiments and research. Being a Scientist - Clinical Research secures grants and funding for research and is responsible for controlling budgets. Summarizes findings in reports and communicates results. Additionally, Scientist - Clinical Research interacts with other scientists within and outside of the organization. Provides recommendations that influence extensive clinical research activities. Requires an advanced degree. Typically reports to head of a unit/department. The Scientist - Clinical Research work is generally independent and collaborative in nature. Contributes to moderately complex aspects of a project. To be a Scientist - Clinical Research typically requires 4 -7 years of related experience. (Copyright 2024 Salary.com)

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Clinical Research Scientist/Sr. Clinical Research Scientist
  • Axsome Therapeutics
  • New York, NY FULL_TIME
  • JOB SUMMARY

    Axsome Therapeutics is seeking a Clinical Research Scientist or Sr. Clinical Research Scientist (based on experience) that reports to the Clinical R&D function, serves as a critical asset to the Clinical Lead and supports the design and delivery of our clinical trials.  The CRS is responsible for the implementation, planning and execution of assigned clinical trial activities and serves as the Clinical Trial Lead for multiple studies. The Clinical Research Scientist will independently lead, plan and execute trial and compound level activities. 

    This is a hybrid role based at Axsome’s HQ in New York City.

    JOB RESPONSIBILITIES

    • Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
    • Plan and lead the implementation all study startup/conduct/close-out activities as applicable
    • Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical R & D Lead)
    • Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality
    • Co-lead study team meetings in partnership with Clinical Operations and collaborates with cross-functional study team members (e.g., Regulatory Affairs, Safety, Data Management).
    • Partner with the Clinical Trial Manager and Study Director to support the overall execution of a clinical studies.
    • Perform regular data reviews to identify trends.
    • Support medical data review and medical coding review.
    • Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on study committee (e.g., DMC) activities
    • Draft/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
    • Collaborate and serve as primary liaison between external partners for scientific advice
    • Facilitate development of case report forms.
    • Support SAE process, query generation, narrative development and review.
    • Support labelling, distribution, and overall accountability of Clinical trial material (CTM) for the clinical study, as needed.
    • Support the review and revision of Standard Operating Procedures (SOPs).
    • Assist in the preparation of abstracts, poster presentations, slides, and manuscripts of clinical study findings.
    • Attend relevant therapeutic area conferences/meetings based on assignments and engages KOLs.
    • Support review of proposed investigator-sponsored research (ISR).

    QUALIFICATIONS/REQUIREMENTS

    • Advanced degree (Pharm.D., MPH, PhD, MS) with at least 5 (Assoc. Dir.) or 8 (Dir.) years of clinical development experience at a pharmaceutical company
    • Experience writing and reviewing clinical documents (eg, protocols, CSRs, IBs, DSURs). Experience with regulatory documents (INDs, briefing books, NDAs)
    • Strong analytical skills with excellent communication (both oral and written)
    • Ability to assimilate technical information quickly
    • Routinely takes initiative
    • Detail-oriented
    • Strong sense of teamwork; ability to lead team activities
    • Proficient in Medical Terminology and medical writing skills
    • Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)
    • Proficient critical thinking, problem solving, decision making skills
    • Thorough understanding of FDA, GCP and ICH guidelines
    • Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities.
    • Excellent team player; willingness and ability to fill functional gaps in a small but growing organization
    • Preference to energetic candidates with a desire to think “outside the box”
    • Proficiency with MS Office suite, Electronic Data Capture, and other reporting tools
    • Willingness to travel as needed, up to 20%
    • Ability to work on site Monday, Tuesday and Thursday

    SALARY & BENEFITS

    The anticipated salary range for this role is $123,000 - $145,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

     

  • 10 Days Ago

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Clinical Research Associate
  • Cognitive Research Corporation
  • New York, NY FULL_TIME
  • Position Summary: The Clinical Research Associate is responsible for tracking and maintaining study specific non-CRF databases and administrating clinical research projects. This is accomplished by co...
  • 3 Days Ago

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Head of Sequencing / Senior Scientist
  • Convergent Research
  • New York, NY FULL_TIME
  • This is an exciting opportunity to join a fast-paced, growing Focused Research Organization (FRO) startup (currently in stealth). Head of Sequencing will conduct NGS-based experimental research and co...
  • 16 Days Ago

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Computational Scientist
  • Riverside Research Institute
  • New York, NY OTHER
  • Riverside OverviewRiverside Research is an independent National Security Nonprofit dedicated to research and development in the national interest. We provide high-end technical services, research and ...
  • 19 Days Ago

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Research Scientist
  • Expentor
  • New York, NY FULL_TIME
  • Job Summary We are looking for a research scientist to design, coordinate, execute, and monitor research studies that enable the development and evaluation of large language models (LLM). In this role...
  • 11 Days Ago

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Research Scientist
  • NYU Langone
  • New York, NY FULL_TIME
  • The NYU Langone Department of Orthopedic Surgery in New York City, NY is seeking an outstanding scientist with expertise in Musculoskeletal Biology and Regenerative Medicine. Expectations for the succ...
  • 14 Days Ago

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0 Scientist - Clinical Research jobs found in Mount Vernon, NY area

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Scientist
  • TalentBurst, an Inc 5000 company
  • Ridgefield, CT
  • Skills Adequate experience of working on various unit operations of pharmaceutical manufacturing processes (direct compr...
  • 3/28/2024 12:00:00 AM

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Associate Scientist
  • Manpower Engineering
  • Trumbull, CT
  • Our client, a chemical and consumer goods manufacturer, is seeking an associate Scientist to join their team. As an Asso...
  • 3/28/2024 12:00:00 AM

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Research Scientist
  • NYU Langone Health
  • New York, NY
  • NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of...
  • 3/28/2024 12:00:00 AM

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Scientist
  • GForce Life Sciences
  • Clark, NJ
  • Job Description: Perform laboratory tasks to support scientific discovery programs related to skin biology under the gui...
  • 3/27/2024 12:00:00 AM

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Scientist
  • Patel Consultants Corporation
  • Danbury, CT
  • Our client needs a Scientist with a strong scientific understanding and experience in bioinformatics. · Experience in ph...
  • 3/26/2024 12:00:00 AM

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Associate Scientist / Senior Associate Scientist
  • Waypoint Bio
  • New York, NY
  • Associate Scientist / Senior Associate Scientist Full-time position Competitive compensation (Salary, Benefits & Options...
  • 3/25/2024 12:00:00 AM

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Scientist / Senior Scientist, Protein Engineer
  • Waypoint Bio
  • New York, NY
  • Scientist / Senior Scientist, Protein Engineer Full-time position Competitive compensation (Salary, Benefits & Options) ...
  • 3/25/2024 12:00:00 AM

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Scientist
  • Patel Consultants Corporation
  • Danbury, CT
  • W-2 Candidates only! Our client needs a Scientist who is highly motivated functional genomics and sequencing scientist t...
  • 3/24/2024 12:00:00 AM

Mount Vernon is a city in Westchester County, New York, United States. It is an inner suburb of New York City, immediately to the north of the borough of the Bronx. As of the 2010 census, Mount Vernon had a population of 67,292....
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Scientist - Clinical Research jobs
$95,958 to $136,426
Mount Vernon, New York area prices
were up 1.6% from a year ago

Scientist - Clinical Research in El Paso, TX
DDCF's Medical Research Program created the Clinical Scientist Development Award to provide mentored research funding to early-career physician-scientist faculty to enable their transition to independent and successful research careers.
December 01, 2019
Scientist - Clinical Research in Green Bay, WI
Jude Children’s Research Hospital, talented faculty and staff work together and with colleagues worldwide-to advance the resear.
January 26, 2020
Scientist - Clinical Research in Sacramento, CA
Bachelor s in Life Sciences or related field with 2 plus years of clinical research experience.
January 11, 2020