Clinical Research Coordinator I
Company: Cone Health
Location: Greensboro
Posted on: January 27, 2023
Job Description:
Clinical Research Coordinator (CRC) I is an entry level
professional title in the Clinical Research Coordinator Family. CRC
I's, work closely with study subjects and other research staff, and
are involved in most steps of the research trial process. CRC?s
participate in clinical research studies conducted by principal
investigator(s) including, but not limited to, grant funded
research and/or industry sponsored clinical research conducted on
site at Cone Health or its affiliated sites; performs a variety of
duties involved in the collection, compilation, documentation and
analysis of clinical research data. They function under the
Principal Investigator?s medical license and cannot perform any
tasks that by state or local law require a license to perform.
Their work is routine in nature, with assignments provided at a
task level, focused on the long term goals of clinical research
trial and process. CRC I's have no supervisory responsibilities and
work under immediate supervision.
- Assesses patients for protocol eligibility. Confers with study
participants to explain purpose of study and obtains informed
consent; explains diagnostic procedures and/or treatment plans to
alleviate patient and/or family concerns; schedules patient for
study procedures; initiates/coordinates drug orders, laboratory
procedures and treatments for patients based on standing protocol
orders. Collects data from patient charts, medical records,
interviews, questionnaires, diagnostic tests and other sources;
codes, evaluates and interprets collected data and prepares
appropriate documentation; obtains blood samples, cultures, tissues
and other specimens for laboratory analysis. Notifies Principal
Investigator and supervisor of subject status.
- Attends Investigator meetings and conferences as required.
- Collects subject data, enters and analyzes data, and compiles
reports, adhering to proper research protocols. Prepares
documentation, reports, graphs, and other materials. Keeps
appropriate logs, tracks participants, and prepares study
materials.
- Serves as Study Coordinator for pharmaceutical trials.
Accurately reviews all study activities prior to activation;
successfully arranges site initiation visits, monitoring visits,
and close-out visits; disseminates new information to research
staff, pharmacy staff, and principal investigator in a timely
fashion. Ensures compliance with protocol guidelines and
requirements of regulatory agencies; identifies problems and/or
inconsistencies and monitors patients? progress to include
documentation and reporting of adverse events; recommends
corrective actions as appropriate.
- Supports regulatory staff submission of study protocols and
amendments, consent forms, and recruiting materials to the
Institutional Review Board and department for approval with
oversight from supervisor.EDUCATION:Required: Associate?s Degree
and four years of relevant experience. Clinical Research
Coordinator (CCRC) and/or Clinical Research Associate (CCRA)
certification, along with a minimum of two years additional
professional experience, will be considered in place of degree. Any
degree substitutions are subject to review by committee.Preferred:
Bachelor?s Degree and one year of clinical research
experience.EXPERIENCE:Preferred: List preferred length and type of
experience.LICENSURE/CERTIFICATION/REGISTRY/LISTING:Required:
- Understanding of ICH/GCP guidelines for human research.
- Understanding of Code of Federal Regulations for Human
Subjects.
- Computer Competency including proficiency in Microsoft Office
and EDC systems.
- Understanding Phases I-IV drug development processes.
- Technical skills related to the completion of a study visit as
required by the protocol.Obtain Good Clinical Practice
certification within 30 days of hire and maintain without lapse.
Obtain Human Subjects Research certification within 30 days of hire
and maintain without lapse.PREFERREDPreferred: Clinical Research
Coordinator (CCRC) and/or Clinical Research Associate (CCRA) is
preferred. Required if candidate does not have Bachelor?s
degreeRequisition ID (iCIMS): 2023-14893 Name: Moses Cone Hospital
Name: MHC - Cardio Vascular Research Requisition Sub Category: RN -
CLIN RESEARCH Relationship to Org: Employee Exempt/NonExempt:
Exempt Street: 1121 N Church St FTE: 1.00 Work Hours: 40.00
Provider Schedule (specific schedule): Day shift Position Sub
Category: RN - Clinical Research
Keywords: Cone Health, Greensboro , Clinical Research Coordinator I, Healthcare , Greensboro, North Carolina
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