Clinical Research Coordinator

Company: Astrix Technology Group (NIH)
Location: Bethesda
Posted on: May 14, 2022

Job Description:

ORGANIZATIONAL HIERARCHY
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 CRF 312.62(b)].
--- 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 trial.
--- 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 procedures.

Clinical Research Team Education
--- Assist with medical staff and support personnel training and facilitate the implementation and understanding of the protocol.
--- Provide protocol-specific instructions to clinic personnel and assure their understanding of specific clinical research procedures.

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 clinical research.
--- Serve as an advocate for participants, and ensure a safe, respectful, and caring environment while maintaining protocol integrity.
--- Provide participants and family education and counseling on clinical research participation and the importance of full compliance with the clinical research process.

DELIVERABLES
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 protocol.
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 deviation.
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 study participant.
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.

BASIC REQUIREMENTS
- Minimum of two (2) years of relevant work experience is required.
- Formal education or professional certification in clinical research may be used as a substitute for work experience.

LOCATION
The world-famous Building 10 on NIH's main campus in Bethesda Maryland

Keywords: Astrix Technology Group (NIH), Bethesda , Clinical Research Coordinator, Healthcare , Bethesda, Maryland