Clinical Research Coordinator
Company: System One
Location: New Haven
Posted on: September 22, 2022
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
- 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.
- 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
- 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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