Clinical Research Coordinator I

The Clinical Research Coordinator I provides support to the faculty of the Section of Pulmonary/Critical Care within the Department of Medicine, coordinating all aspects of conducting clinical trials, maintaining accurate documentation, and planning and coordinating patient schedules.

Requirements

• Screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports
• Maintenance of 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
• Performance of specific protocol procedures, such as specimens and data management, survey/questionnaire administration, and collection of information about adverse events (AEs)
• Planning and coordination of patient schedule for study procedures, return visits, and study treatment schedules
• Implementation of Standard Operating Procedures (SOP) according to study sponsor, primary investigator, and regulatory agency specifications
• Preparation and maintenance of protocol submissions and revisions
• Education of patients about study procedures, visit schedule, and potential side effects
• Performance of assessments at visits and monitoring for adverse events
• Organization and attendance of site visits from sponsors and other relevant study meetings
• Recruitment and interview of potential study patients
• Obtaining, possessing, and transporting specimens to appropriate laboratory according to established aseptic techniques
• Preparation for or participation in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups
• Accountability for all tasks in basic clinical studies
• Use of knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Health benefits
• Paid time off