Clinical Research Coordinator I

The Clinical Research Coordinator I provides support to the faculty of the Section of Hematology/Oncology within the Biological Sciences Division. The CRC1 will be involved in multiple research trials types: multi-centered cooperative group and intergroup studies at a national level, multi-institutional pharmaceutical trials, and multi-centered trials designed, implemented and coordinated in the Section.

Requirements

• Coordinates all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
• Maintains accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
• Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
• Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
• Prepares and maintains protocol submissions and revisions.
• Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and potential side effects.
• Performs assessments at visits and monitors for adverse events.
• Organizes and attends site visits from sponsors and other relevant study meetings.
• May recruit and interview potential study patients. May obtain, possess, and transport specimens to appropriate laboratory according to established aseptic techniques.
• Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
• Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
• Accountable for all tasks in basic clinical studies.
• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.

Benefits

• Health, retirement, and paid time off
• Employee benefits guide