Clinical Research Coordinator II

Job Summary

Job Duties

• Coordinates and implements clinical research studies.
• Prepares submissions for Institutional Research Review Board consideration and provides oversight for all reporting obligations.
• Responsible for conduct of the clinical trial, including but not limited to recruitment, screening, enrollment, and follow-up of eligible subjects according to protocol requirements.
• Develops and implements subject recruitment plans including interviewing subjects, collaborating with physicians, screening, and enrolling.
• Performs nursing physical and psychosocial assessments of research patients in the outpatient and inpatient areas of the hospital.
• Monitors research patients in outpatient and inpatient settings for adverse experiences and compliance with study protocols.
• Administers and monitors study drug as directed by the investigator and clinician.
• Performs triage nursing assessments of subjects as needed.
• Reviews medical records of patients, interviews patients and collaborates with investigators and clinicians to assess the appropriateness of patients for clinical trial enrollment.
• Develops study-specific training tools and procedures to orient patient care staff about research interventions and protocols.
• Monitors lab results and reports all findings to the principal investigator.
• Informs principal investigator of all relevant patient care issues and activities within research study.
• Collaborates with nursing staff and research personnel to incorporate all details of research protocol.
• Insures appropriate billing charge documents are submitted.
• Educates staff, as needed, to insure proper billing for study-related procedures in outpatient and inpatient areas.
• Reviews monthly study-specific financial statements for accuracy and budget adherence.
• Provides education to subjects and family on specific research protocols, potential risks, benefits, and reporting of health events.
• Serves as a liaison between the principal investigator and the study sponsor for adapting a multi-center protocol to the specific local environment.

Work is typically performed in an office environment. Accountable for satisfying all job specific obligations and complying with all organization policies and procedures. The specific statements in this profile are not intended to be all-inclusive. They represent typical elements considered necessary to successfully perform the job.

Education

Experience

Certification(s) and License(s)