Clinical Research Coordinator
Company: Astrix Technology Group (NIH)
Posted on: May 14, 2022
National Institutes of Health (NIH)
National Eye Institute (NEI)
Office of the Clinical Director (OCD)
Clinical Operations Branch (COB)
Clinical Research Coordinating Section (CRCS)
ROLES / RESPONSIBILITES
The Clinical Research Coordinator is a recognized expert in
clinical research protocol development, implementation, and
management in a highly specialized discipline of ophthalmology. The
Clinical Research Coordinator plays a vital role in educating
potential participants and the research team about the NEI
intramural clinical trials.
Protocol Design, Development, Implementation and Coordination
--- Design and maintain organizational tools that will aid in the
conduct of the study. Ensure clinical studies are carry out as
outline in the research protocol and comply with FDA regulations
and ICH Good Clinical Practice Guidelines as appropriate.
--- Facilitate communication with the study monitor to discuss the
study's conduct and review study data in association with or as
directed by the Investigator.
--- Complete electronic or paper case report forms (CRF) accurately
and as delineated in the protocol (Note: While the study
coordinator is responsible for completing CRFs, the PI is
eventually accountable for the content and accuracy of the data.
The PI must review and may be required to sign every CRF indicating
that they concur with the CRF information.)
--- Maintain source documentation (any document or record where the
subject's research data is first recorded). All data documented on
the CRF should be verifiable by supporting source documentation [21
--- Assist the PI in preparing for site visits from the clinical
research monitor, FDA, and other regulatory agencies by collecting
and organizing all research data sources pertinent to the clinical
--- Assist PI in organizing appropriate documentation for protocol
reviews and modifications to the clinical research protocol by
Federal regulations and institute policies and procedures.
--- Assure adherence with scientific and compliance reporting
requirements per Federal regulations and institute policies and
Clinical Research Team Education
--- Assist with medical staff and support personnel training and
facilitate the implementation and understanding of the
--- Provide protocol-specific instructions to clinic personnel and
assure their understanding of specific clinical research
Human Subject Protection
--- Report all adverse events (AEs) and serious or unexpected
adverse events (SAEs) to the PI. Assist the PI document and report
all AEs/SAEs to the IRB and sponsor as required by FDA regulations
or ICH Good Clinical Practice Guidelines.
Supportive Care & Education
--- The clinical trial coordinator will ensure participants are
provided the highest level of care during their participation in
--- Serve as an advocate for participants, and ensure a safe,
respectful, and caring environment while maintaining protocol
--- Provide participants and family education and counseling on
clinical research participation and the importance of full
compliance with the clinical research process.
Screen and recruit potential study participants according to the
protocol's inclusion and exclusion criteria.
Ensure informed consent forms are labeled with the participants'
identification, signed, and dated by the participant and the PI/AI,
and filed in the medical record.
Obtain proper written informed consent from study participants and
document the consent process before participants partakes in
collecting clinical research data.
Ensure clinical studies are carry out as outline in the research
Schedule study participants' visits and outline the study visit
activities by developing a framework of the entire visit related to
the clinical research study.
Track and maintain accurate records of participants taking part in
clinical research studies using enrollment log forms, clinical
research forms, and protocol mapping tools.
Assign study subject numbers, maintain accurate and complete
records of the receipt, dispensing and return of all clinical
supplies or medications and document any discrepancy or
Complete electronic or paper case report forms (CRF) accurately and
as outlined in the protocol.
Maintain accurate and complete paper or electronic CRF for every
Assure medical personnel and support personnel participating in
clinical research are qualified (certified) to perform their
assigned duties as outlined in the clinical research protocol.
- Minimum of two (2) years of relevant work experience is
- Formal education or professional certification in clinical
research may be used as a substitute for work experience.
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Keywords: Astrix Technology Group (NIH), Bethesda , Clinical Research Coordinator, Healthcare , Bethesda, Maryland
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