Details:
- Compensation: $65 - $70k
- Benefits: Medical, Dental, Vision
- Employment Classification: Direct Hire
- Status: On-Site
- Job ID: 22347
Clinical Research Coordinator
Hinsdale, IL
Responsibilities:
• Maintaining site regulatory files.
• Working with IRBs, initial submission, modifications, continuing reviews, etc.
• Prescreen, recruit and screen patients for studies.
• Execute Informed Consent process according to ICH and GCP guidelines.
• Create source and document study visits in source according to ALCOA-CCC.
• Perform phlebotomy, process, and ship blood and urine samples according to protocol / lab manual.
• Enter source document data into respective EDC vendor system (Medidate RAVE, etc) and respond to queries in a timely manner.
• Perform vitals, ECG, and other study assessments required by protocol.
• Record adverse events and serious adverse events per sponsor guidance. Maintain timely follow-up to determine resolution of adverse event.
• Monitor, dispense, collect investigational product; maintain accountability logs and temperature logs and report temperature excursions; work in IRT systems.
• Schedule, prepare, and conduct study visits (SSV, SIV, IMVs, COV) with sponsor/CRO team.
Qualifications:
Hinsdale, IL
Responsibilities:
• Maintaining site regulatory files.
• Working with IRBs, initial submission, modifications, continuing reviews, etc.
• Prescreen, recruit and screen patients for studies.
• Execute Informed Consent process according to ICH and GCP guidelines.
• Create source and document study visits in source according to ALCOA-CCC.
• Perform phlebotomy, process, and ship blood and urine samples according to protocol / lab manual.
• Enter source document data into respective EDC vendor system (Medidate RAVE, etc) and respond to queries in a timely manner.
• Perform vitals, ECG, and other study assessments required by protocol.
• Record adverse events and serious adverse events per sponsor guidance. Maintain timely follow-up to determine resolution of adverse event.
• Monitor, dispense, collect investigational product; maintain accountability logs and temperature logs and report temperature excursions; work in IRT systems.
• Schedule, prepare, and conduct study visits (SSV, SIV, IMVs, COV) with sponsor/CRO team.
Qualifications:
- Bachelor's Degree
- 1+ Year of experience in a FDA Regulated Industry supporting Sponsored Drug Trials
- GCP and IATA Certified