Oncology Clinical Research Coordinator (NOT REMOTE)

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 IIV 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

Bachelors degree in Nursing, Life Sciences, Health Sciences, Clinical Research, or related field.

Experience

Minimum 23 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