Top Clinical Research Executive jobs in New Jersey

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

    A CRC 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
    • Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
    • Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
    • Facilitate effective communication between patients, healthcare providers, and research staff
    • 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
    Knowledge and Skills:
    • Goals-driven while continuously maintaining quality.
    • Must be detailed-oriented, proactive, and able to take initiative.
    • Must have strong written and communication skills.
    • Must have excellent customer service skills.
    • Proficient communication and comprehension skills both verbal and written in the English language are required.
    • Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.
  • 2 Days Ago

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Clinical Research Coordinator I
  • DM Clinical Research
  • Jersey, NJ FULL_TIME
  • Lab TechnicianThe Lab Technician will be responsible for assisting the clinical research staff in conducting clinical research trials.Duties & Responsibilities:Prepares, processes, and ships laborator...
  • 7 Days Ago

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Research Assistant I
  • DM Clinical Research
  • Jersey, NJ FULL_TIME
  • Research Assistant I The Research Assistant will be responsible for assisting the clinical research staff in conducting clinical research trials. DUTIES & RESPONSIBILITIESCompleting DMCR-required trai...
  • 1 Month Ago

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Clinical Data Manager
  • Everest Clinical Research
  • Bridgewater, NJ FULL_TIME
  • Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechn...
  • 19 Days Ago

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Project Manager-CRO
  • LOTUS CLINICAL RESEARCH LLC
  • New Providence, NJ FULL_TIME
  • Job Title: Project Manager Location: Remote Job Description: The Project Manager is a proven leader in clinical program management in the clinical research industry, and manages, executes, and reports...
  • 2 Days Ago

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Principal Biostatistician (Remote)
  • Everest Clinical Research
  • Bridgewater, NJ FULL_TIME
  • Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechn...
  • 23 Days Ago

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Research Staff Assistant
  • Columbia University
  • New York, NY
  • * Job Type: Support Staff - Non-Union * Bargaining Unit: * Regular/Temporary: Regular * End Date if Temporary: * Hours P...
  • 4/26/2024 12:00:00 AM

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Research Professional I
  • University Of Georgia
  • Griffin, GA
  • Research Professional I Below you will find the details for the position including any supplementary documentation and q...
  • 4/24/2024 12:00:00 AM

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Researcher - Executive Search
  • FIFTEEN WEST
  • ROLE: Associate Consultant - Executive Search LOCATION: New York, Midtown CLIENT: Boutique Global Executive Search firm ...
  • 4/23/2024 12:00:00 AM

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Research Professional
  • University Of Georgia
  • Griffin, GA
  • Research Professional Below you will find the details for the position including any supplementary documentation and que...
  • 4/23/2024 12:00:00 AM

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Research Staff Nurse
  • Brigham And Womens Hospital
  • Boston, MA
  • Job Description - Research Staff Nurse (3286660)Research Staff Nurse - ( 3286660 )RESEARCH STAFF NURSE / PER DIEM DAY SH...
  • 4/23/2024 12:00:00 AM

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Research Coordinator (Research Professional 3)
  • University of Minnesota
  • Minneapolis, MN
  • About the Job Job Duties/Responsibilities: * Screen and recruit clinical trial subjects by pre-screening clinic patients...
  • 4/22/2024 12:00:00 AM

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Member of Research Staff - Fujitsu Research
  • Fujitsu
  • Sunnyvale, CA
  • Job Description Fujitsu Research of America (FRA) was founded in Silicon Valley to extend the global reach of Fujitsu R&...
  • 4/22/2024 12:00:00 AM

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Clinical Research Coordinator (Research Professional 1)
  • University of Minnesota
  • Minneapolis, MN
  • About the Job The primary purpose of the Clinical Research Coordinator (Research Professional 1) position includes: cond...
  • 4/22/2024 12:00:00 AM

New Jersey is bordered on the north and northeast by New York (parts of which are across the Hudson River, Upper New York Bay, the Kill Van Kull, Newark Bay, and the Arthur Kill); on the east by the Atlantic Ocean; on the southwest by Delaware across Delaware Bay; and on the west by Pennsylvania across the Delaware River. New Jersey is often broadly divided into three geographic regions: North Jersey, Central Jersey, and South Jersey. Some New Jersey residents do not consider Central Jersey a region in its own right, but others believe it is a separate geographic and cultural area from the Nor...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Clinical Research Executive jobs
$230,838 to $421,290