Clinical Research Coordinator I
Company: Cone Health
Location: Greensboro
Posted on: April 18, 2024
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Job Description:
Clinical Research Coordinator I
ID
2024-23694
Location
Cone Health Cancer Center
Work Location
US-NC-Greensboro
Division : Name
Cancer Center
Department : Name
WLCH-CC-PRECISION HEALTH
Category
NURSING
Position Sub-Category
LPN - HOSP- OUTPAT
Position Type
Benefit Eligible (12-39 hours/week)
Employment Type
Employee
Exempt/NonExempt
Non-Exempt
FTE
0.80
Workforce Status
Hybrid I
Work Hours
32.00
Provider Schedule (specific schedule)
M-F
On call Required
No
Sub Category
LPN - Hospital - Outpat Care
Overview
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.
Responsibilities
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.
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Attends Investigator meetings and conferences as required.
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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.
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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.
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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.
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Qualifications
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
Required:
1. Understanding of ICH/GCP guidelines for human research.
2. Understanding of Code of Federal Regulations for Human
Subjects.
3. Computer Competency including proficiency in Microsoft Office
and EDC systems.
4. Understanding Phases I-IV drug development processes.
5. 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.
PREFERRED
Preferred: Clinical Research Coordinator (CCRC) and/or Clinical
Research Associate (CCRA) is preferred. Required if candidate does
not have Bachelor?s degree
Keywords: Cone Health, Greensboro , Clinical Research Coordinator I, Healthcare , Greensboro, North Carolina
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