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Clinical Research Coordinator

Company: System One
Location: New Haven
Posted on: September 22, 2022

Job Description:

Title: Clinical Research Coordinator Location: New Haven, CT (will need to be on site) Duration: Direct Hire Schedule: 37.5 hours M-F, occasional weekend and evening hours Target Start Date: ASAP Responsibilities: Planning, tracking, and ensuring that the clinical activities for study participants are conducted in accordance with approved protocols. These activities include, but are not limited to patient screening, eligibility determination, registration and other protocol and subject milestones. The CRC will have direct patient contact and will be responsible for managing a multitude clinical trials.

  • Manages and organizes assigned site studies. Serves as the primary organizer for assigned trials regarding conduct and oversight of human clinical research.
  • Tracks and reports adverse events, serious adverse events, protocol waivers, deviations and violations. Assists investigators in the preparation of corrective action plans and ensures implementation and adherence to stated plan.
  • Documents and conveys study data. Supervises assigned staff to ensure that report forms are accurately documented and completed in a timely manner at each site location.
  • Assists in ensuring principal investigator oversight by providing updates on protocol issues, obtaining signatures and clinical significance on lab reports, ECGs, adverse events and other documents as required.
  • Designs and implements quality control measures to ensure accurate collection and processing of data.
  • Ensures adherence to protocol for all study participants throughout the duration of participation in the clinical trial. Identifies instances of noncompliance and deviations from protocol and reports noncompliance and deviations to the appropriate parties. Assists investigators and Clinical Trial Managers in the preparation and execution of corrective and preventative action plans.
  • Abstracts concomitant medications from medical records.
  • Maintains a high degree of knowledge on regulatory and policy requirements to determine actions and follow directives that may be required to ensure compliance with congruency review and reporting requirements. Develops, implements, and manages internal practices that ensure compliance with federal requirements. Requirements:
  • One year of Oncology clinical trial experience. Masters degree in health or research related discipline preferred. or Bachelors degree and a minimum of 3 years of related research support experience; Experience must indicate the ability to work with minimal supervision in a team environment.
  • Certification as a Clinical Research Associate or Clinical Research Professional (ACRP or SOCRA) preferred
  • Demonstrated ability to create and follow research project related supporting documents.
  • Proven ability to schedule and coordinate research activities as well as work with a team to develop action items and other means to keep projects moving along according to timeline.
  • Demonstrated ability to report on the status of project deliverables and draft and submit project updates to the study sponsor.
  • Strong clinical and analytical skills. Proven ability to evaluate and assess subjects suitability for inclusion into studies, obtain informed consent, determine patient eligibility and coordinate patient enrollment.System One, and its subsidiaries including Joul, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Keywords: System One, New Haven , Clinical Research Coordinator, Healthcare , New Haven, Connecticut

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