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Lead Clinical Research Associate

Company: Joule
Location: New Haven
Posted on: May 4, 2021

Job Description:

Title: Lead Clinical Research Associate Location: New Haven, CT Duration: Direct Hire Schedule: 37.5 hours, occasional weekend and evening hours (travel is required outside of CT) Target Start Date: April 2021 Responsibilities:

  • Conducts clinical research monitoring for clinical trials conducted
  • Advocates for the advancement of critical strategic objectives that promote effective, efficient, and compliant management of clinical studies with a focus in commercial INDs/IDEs.
  • Independently tracking, planning, ensuring the research activities are conducted in accordance with approved protocols and reporting monitoring activities.
  • Developing project specific monitoring plans via evaluation of the project risk and in accordance with FDA guidance, as well as monitoring for multiple clinical trials. The monitoring activities performed include but are not limited to: Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, Close Out Visits per protocol specific monitoring plans.
  • May be responsible for management and oversight of protocol specific Data and Safety Monitoring Boards.
  • Oversees the execution and implementation of detailed project plans in concert with stakeholders.
  • Manages several routine projects simultaneously and ensures that the design, testing, training, documentation and prioritization objectives are met.
  • Assists in refining and re-sequencing during the implementation and execution phases of assigned projects, as needed.
  • Requirements:
    • Master's degree strongly preferred.
    • Min Bachelor's Degree in a related field and five years of related work experience or equivalent combination of education and experience.
    • 7 years of clinical trials experience as an auditor, clinical research associate or equivalent for an industry Sponsor or CRO strongly preferred.
    • Experience as auditor, clinical research associate or equivalent for industry Sponsor or CRO managing FDA and/or EMA regulated clinical trials. Extensive experience in all facets of study start-up/activation, external site feasibility, participant enrollment, on-going management of multiple-external sites & protocols, study close-out, & regulatory.
    • Comprehensive understanding of clinical research review, approval and Data and Safety Monitoring processes. Comprehensive knowledge of federal regulations concerning the protection of human subjects and clinical trial design, implementation and analysis.
    • Extensive knowledge and application of auditing and monitoring techniques and practices. Professionalism, maturity, good judgment, and the ability to work with confidential material. The ability to work remotely; including an adequate workspace with internet access. Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

Keywords: Joule, New Haven , Lead Clinical Research Associate, Healthcare , New Haven, Connecticut

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