The Clinical Research Coordinator II is a specialized researcher partnering with the clinical Principal Investigator and under the direction of the Clinical Research Manager in the Section of Gastroenterology in the Department of Medicine. The role is responsible for managing all aspects of conducting clinical trials, recruiting and interviewing potential study patients, and coordinating patient schedule for study procedures.
Requirements
- Manages all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
- Recruits and interviews potential study patients with guidance from PI and other clinical research staff.
- Collects, processes, ships and stores specimens to appropriate laboratory according to established aseptic techniques.
- Coordinates the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
- Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
- Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.
- Performs assessments at visits and monitors for adverse events.
- Organizes and attends site visits from sponsors and other relevant study meetings.
- Protects patients' and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
- Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
- Understands the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.
- Ensures compliance with federal regulations and institutional policies.
- May prepare and maintain protocol submissions and revisions.
- Assist in the training of new or backup coordinators.
- Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits.
- Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.
- Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.
- Accountable for all tasks in moderately complex clinical studies.
- Performs other related work as needed.
Benefits
- Health insurance
- Retirement plan
- Paid time off
