•Bachelor’s degree in Nursing, Life Sciences, Health Sciences, Clinical Research, or related field
•Minimum 2–3 years experience coordinating oncology clinical trials
•Strong understanding of oncology clinical trial operations
•Knowledge of ICH-GCP and FDA regulations
•Experience with EDC systems
•Strong organizational and time-management skills
•Excellent patient communication skills
•4 more items(s)
Responsibilities
•Total Health and Research Center (THRC) is seeking an experienced Oncology Clinical Research Coordinator (CRC) to support Phase I–IV clinical trials in oncology and other therapeutic areas
•The Oncology CRC will be responsible for the day-to-day coordination of clinical trials, ensuring protocol compliance, patient safety, regulatory adherence, and high-quality data collection
•Key ResponsibilitiesStudy Coordination
•Coordinate all aspects of clinical trials from site initiation through study close-out
•Conduct protocol review and feasibility assessments
•Prepare site for site qualification visits, site initiation visits, and monitoring visits
•Ensure compliance with FDA, ICH-GCP, sponsor protocols, and IRB requirements
•Identify and recruit eligible patients through EMR and physician referrals
•Screen potential participants according to protocol inclusion/exclusion criteria
•Schedule and coordinate screening procedures, labs, imaging, and biopsies
•Conduct or assist with informed consent process
•Participant Management
•Coordinate all study visits and treatment cycles
•Track protocol visit schedules and treatment windows
•Monitor participants for adverse events and safety signals
•Ensure accurate concomitant medication tracking
•Oncology Treatment Coordination
•Coordinate with infusion staff for investigational drug administration
•Verify dose calculations and treatment schedules
•Coordinate safety labs and pre-treatment requirements
•Data Management
•Enter study data into EDC systems
•Maintain source documentation and regulatory binders
•Resolve data queries from sponsors and CROs
•Regulatory Compliance
•Maintain regulatory documents including IRB submissions and protocol amendments
•Ensure adherence to Good Clinical Practice (GCP) guidelines
•Monitoring and Audits
•Prepare for monitoring visits, sponsor audits, and FDA inspections
•Address monitoring findings and implement corrective actions