Job Description

Overview:

The Clinical Research Coordinator II works closely with study subjects and other research staff and is responsible for the day-to-day clinical research process to collect, compile, document, and analyze clinical research data. Working under general supervision, the position conducts subject follow-up visits, completes clinical tasks, prepares research documentation, reports, and graphs while keeping appropriate logs, tracking participants, and preparing study materials.
Responsibilities:
Coordinates multiple clinical trials simultaneously or clinical trials with unique complexity, managing and organizing various research activities efficiently, ensuring optimal use of resources and timely execution of research protocols.
Assesses patients for protocol eligibility, ensuring the appropriate selection of participants for clinical trials, thereby enhancing the accuracy and validity of research outcomes. Confers with study participants to explain the purpose of the study and obtains informed consent, fostering transparency and trust with patients and their families throughout the research process.
Collects data from various sources, including patient charts, medical records, interviews, and diagnostic tests, and prepares comprehensive documentation, ensuring the accurate and reliable analysis of research data. When applicable, completes documentation in the electronic health/medical record (EMR) system to securely maintain patient health records.
Completes clinical tasks (i.e., ECGs, PFTs, phlebotomy, drug administration, etc.) when not prohibited by state or licensing board requirements under the supervision of the principal investigator.
Serves as study coordinator for pharmaceutical and/or device trials, successfully coordinating site initiation visits, monitoring visits, and close-out visits, and ensuring adherence to protocol guidelines and regulatory requirements.
Supports the regulatory process in the submission of study protocols, consent forms, and recruiting materials to the Institutional Review Board and the department for approval, facilitating the regulatory compliance necessary for research projects in the hospital/medical group setting.
Mentors and trains Clinical Research Coordinators and Clinical Research Specialists to ensure an effective and compliant team.
Performs other duties as assigned. Qualifications:

EDUCATION: Required: Associate degree with 4 years of Clinical Research experience OR Bachelor's degree with 2 years of clinical research experience

EXPERIENCE: Required: 6 years (education and/or experience)

LICENSURE/CERTIFICATION/REGISTRY/LISTING: Required: Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) certification

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