Top Clinical Research Executive jobs in Union, NJ

Top Clinical Research Executive plans and directs all aspects of the clinical research function for a healthcare organization. Develops research studies and creates standards and guidelines for clinical research services and programs. Being a Top Clinical Research Executive ensures adherence to SOPs, Good Clinical Practice and FDA regulations. Requires an advanced degree. Additionally, Top Clinical Research Executive typically reports to top management. The Top Clinical Research Executive manages a departmental function within a broader corporate function. Develops major goals to support broad functional objectives. Approves policies developed within various sub-functions and departments. To be a Top Clinical Research Executive typically requires 8+ years of managerial experience. Comprehensive knowledge of the overall departmental function. (Copyright 2024 Salary.com)

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CRC III
  • DM Clinical Research
  • Jersey, NJ FULL_TIME
  • Clinical Research Coordinator III

     

    The Clinical Research Coordinator III will ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. To ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. 

     

    DUTIES & RESPONSIBILITIES


    • Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.
    • Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to:
      • Sponsor-provided and IRB-approved Protocol Training
      • All relevant Protocol Amendments Training
      • Any study-specific Manuals Training, as applicable
      • Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
    • Conducting and overseeing study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.
    • Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.
    • Completing and overseeing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.
    • Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
    • Demonstrated understanding, implementation and supervision of protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory for assigned protocols.
    • Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives for assigned protocols.
    • Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s)
    • Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s).
    • Ability to train and mentor site staff, as needed
    • Supervise visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) 
    • Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
    • Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s).
    • Maintaining a working knowledge of Study Participants’ Scheduling, Visit Tracking, Stipends and Transportation by liaising with the Administrative team.
    • Maintaining a working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s)
    • Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines.
    • Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
    • Being prepared for and available at all required company meetings.
    • Submitting required administrative paperwork per company timelines.
    • Occasionally attending out-of-town Investigator Meetings
    • Any other matters as assigned by management

     

    KNOWLEDGE & EXPERIENCE

     

    Education:

    • High School Diploma or equivalent required
    • Bachelor's degree preferred
    • Foreign Medical Graduates preferred 


    Experience:

    • Minimum of 5 years experience in Clinical Research
    • Supervisory experience preferred
    • Wide therapeutic range of clinical trials experience preferred
    • Regulatory research experience is a plus

     

    Credentials:

    • ACRP or equivalent certification is preferred 

     

    Experience:

    • Minimum of 5 years experience in Clinical Research
    • Supervisory experience preferred
    • Wide therapeutic range of clinical trials experience preferred
    • Regulatory research experience is a plus

     

  • 17 Days Ago

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Travel Clinical Research Coordinator
  • Care Access
  • Newark, NJ FULL_TIME
  • What We Do Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physici...
  • 1 Day Ago

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Jr. Clinical Research Coordinator
  • SGS
  • Union, NJ FULL_TIME
  • Company DescriptionWe are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 97,000 emplo...
  • 14 Days Ago

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Clinical Research Scientist
  • Global Channel Management, Inc.
  • Madison, NJ FULL_TIME
  • Company DescriptionGlobal Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of e...
  • 14 Days Ago

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Clinical Research Scientist
  • Mitsubishi Tanabe Pharma America
  • Jersey, NJ FULL_TIME
  • Company DescriptionEntrepreneurialSpirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent co...
  • 14 Days Ago

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Assistant Clinical Research Coordinator
  • Frontage Laboratories
  • Secaucus, NJ FULL_TIME
  • Assistant Clinical Research CoordinatorTitle: Assistant Clinical Research CoordinatorLocation: Secaucus, NJReports to: Manager of Clinical Operations.Full-time/ Hourly Frontage Laboratories Inc. is an...
  • 16 Days Ago

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0 Top Clinical Research Executive jobs found in Union, NJ area

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Quantitative Equity Research | Execution & TCA
  • Selby Jennings
  • New York, NY
  • A large asset manager (>$1 trillion AUM) who are actively building their Equity Quantitative Analytics and Execution Res...
  • 3/29/2024 12:00:00 AM

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Editorial Project Manager, Researcher, & Executive Assistant
  • M+D Consulting LLC
  • New York, NY
  • Job Description Job Description Background M+D is leading a number of conference program and editorial initiatives for h...
  • 3/29/2024 12:00:00 AM

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Research Technician
  • 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...
  • 3/27/2024 12:00:00 AM

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Research Associate
  • 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...
  • 3/27/2024 12:00:00 AM

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Research Coordinator
  • 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...
  • 3/27/2024 12:00:00 AM

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Research Coordinator
  • 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...
  • 3/27/2024 12:00:00 AM

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Research Technician
  • 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...
  • 3/26/2024 12:00:00 AM

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Research Project Manager
  • 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...
  • 3/26/2024 12:00:00 AM

Union Township, New Jersey is the name of several places in New Jersey:...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Clinical Research Executive jobs
$237,847 to $434,088
Union, New Jersey area prices
were up 1.6% from a year ago