Lead Clinical Research Associate
Location: New Haven
Posted on: May 4, 2021
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
- 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.
- 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
- 7 years of clinical trials experience as an auditor, clinical
research associate or equivalent for an industry Sponsor or CRO
- 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
- 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
Keywords: Joule, New Haven , Lead Clinical Research Associate, Healthcare , New Haven, Connecticut
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