Job Overview
Job Description
Overview:
As a Clinical Research Coordinator II, one will closely collaborate with study participants and other personnel involved in the research process, and will be accountable for managing the routine clinical research procedures. This includes gathering, organizing, recording, and scrutinizing clinical research information. The role requires working under minimal supervision to oversee patient follow-ups, complete clinical assignments, and generate research papers, graphs, and reports. Moreover, it requires accurate record-keeping, participant tracking, and preparation of study resources.
Responsibilities:
Executes clinical responsibilities, including ECGs, phlebotomy, drug administration, PFTs, etc., subject to the direction of the principal investigator, unless they are not permitted by state or licensing board regulations.
The individual acts as a coordinator for medication and/or equipment clinical trials, managing site initiation visits, monitoring visits, and close-out visits, while ensuring compliance with protocol guidelines and regulatory standards.
The electronic health/medical record (EMR) system is utilized to maintain patient health records with utmost security by ensuring appropriate documentation.
Gathering information from multiple sources, such as medical records, assessments, patient interviews, and diagnostic exams, and creating detailed documentation to ensure precise and dependable research data analysis.
Supports in submitting study protocols, consent forms, and recruitment materials to the Institutional Review Board and the department for approval, streamlining the regulatory compliance aspect of research projects in the hospital/medical group facility.
It is the responsibility of the mentors to train Clinical Research Coordinators I and Clinical Research Specialists I & II to develop a qualified and compliant workforce.
Executes additional responsibilities as instructed.
Qualifications:
EDUCATION:
Required:
EXPERIENCE:
Required:
LICENSURE/CERTIFICATION/REGISTRY/LISTING:REQUIRED
Required:
Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) certification
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