Clinical Research Coordinator
Company: Carle Health
Posted on: January 24, 2023
The Clinical Research Coordinator (CRC) is a specialized research
professional that facilitates and coordinates the daily activities
of a clinical trial and plays a critical role in the conduct of the
study. The CRC conducts clinical trials using good
clinical/scientific practices under the auspices of the Principle
Investigator and in collaboration with clinical departments and
sponsors. The CRC is responsible for managing clinical trials from
initiation through closure which can include coordinating study
development; feasibility evaluation and preparation; IRB
submission; recruiting subjects and assessing subject eligibility;
reporting of adverse events; data collection and reporting;
maintaining regulatory documents; assisting with study
modifications; and completing case report forms.
Bachelors Science and/or Bachelors Health or Five (5) years of
clinical trials research or healthcare related experience is
accepted in lieu of education. Masters degree preferred
CERTIFICATION & LICENSURE REQUIREMENTS
SOCRA Certification required three (3) years after hire.
SKILLS AND KNOWLEDGE
Competency in medical terminology required. Strong organizational,
writing, and speaking skills; able to collect, organize and
maintain detailed data; effective interpersonal communication
skills; attention to detail; understanding of all applicable
research regulatory guidelines. Prefer prior experience
coordinating and managing clinical research trials.
- Works in collaboration with the Principle Investigator
- Assists Regulatory Specialist in maintaining regulatory
- Conducts protocol and feasibility evaluation.
- Assesses patient population, recruitment and enrollment
- Recruits and manages trial subjects to include screening
patients for protocol eligibility, covering informed consent,
screening and inclusion/exclusion of the subjects adhering to
safety and compliance issues.
- Performs and/or coordinates tissue processing and subject's
participation in clinical diagnostic procedures.
- Assists with maintenance of research related inventories for
- Assists in accurate and timely data collection, collection of
source documents documentation, data entry, and reporting.
- Schedules, coordinates planning and participates in monitoring
and auditing activities.
- Participates in required training and education programs.
- Assists PI in development of materials and tools necessary to
appropriately train individuals involved in the conduct of the
study around issues related to but not limited to, protocol
requirements, schedule of subject visits, execution of research
plan. Maintains documentation of training.
- Retains all study records in accordance with sponsor
- Maintains effective and timely communications with sponsor,
research subjects and PI during the course of the study.
- Provides a safe environment for patients, families, and
clinical staff at all time through compliance with all federal,
state, and professional regulatory standards.
- Reports instances of noncompliance to appropriate institutional
- Maintains strict patient confidentiality according to HIPAA
regulations and applicable law.
- Follows all clinical procedures and guidelines as set forth by
- Close-out of the clinical trial, contributing to research
article, audit preparation, trial closure, communication with
authorities and other disciplines involved, assisting in the final
study report, completing financial obligations and archives study
- Recognize potential obstacles and work to resolve them within
We are an Equal Opportunity Employer and do not discriminate
against any employee or applicant for employment because of race,
color, sex, age, national origin, religion, sexual orientation,
gender identity, status as a veteran, and basis of disability or
any other federal, state or local protected class. Carle Health
participates in E-Verify and may provide the Social Security
Administration and, if necessary, the Department of Homeland
Security with information from each new employee's Form I-9 to
confirm work authorization. - For more information:
Effective September 20, 2021, the COVID 19 vaccine is required for
all new Carle Health team members. Requests for medical or
religious exemption will be permitted.
Keywords: Carle Health, Champaign , Clinical Research Coordinator, Healthcare , Urbana, Illinois
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