Oncology Clinical Research Coordinator

Job description:

Position Title:

Oncology Clinical Research Coordinator (CRC) Position Type Full-Time Reports To Research Director / Principal Investigator Position Summary 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 Responsibilities Study 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 Patient Recruitment and Screening
• 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 Required Qualifications Education Bachelor's degree in Nursing, Life Sciences, Health Sciences, Clinical Research, or related field.

Experience Minimum 2-3 years experience coordinating oncology clinical trials. Experience with oncology protocols, infusion studies, RECIST imaging, and serious adverse event reporting preferred. Certifications (Preferred)

• ACRP Certified Clinical Research Coordinator (CCRC)

• SOCRA CCRP

  Certification
• GCP Certification
• Human Subjects Protection Training (CITI) Required Skills
• 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 Application Question(s): Do you have Clinical Research experience specifically dealing with Oncology?

Do you have Clinical Research experience in Oncology? This position is located in Miami and is not a remote position. Are you located in Miami? (You will not be considered for this role if you do not reside in Miami)

Work Location:

In person Application Question(s): Do you have Clinical Research experience specifically dealing with Oncology? Do you have Clinical Research experience in Oncology? This position is located in Miami and is not a remote position. Are you located in Miami? (You will not be considered for this role if you do not reside in Miami)

Work Location:

In person