Job Title: Clinical Research Associate (CRA) – Phase I Oncology

Location: Durham, NC

Duration: 3-Month Contract (Possible Extension)

Schedule: 40 Hours/Week

Pay Rate: $28/Hour

Job Summary

We are seeking an experienced Clinical Research Associate (CRA) to support sponsor-side oversight of Phase I Oncology clinical trials. The ideal candidate will oversee investigational sites, conduct monitoring visits, ensure protocol compliance, and collaborate with CROs and cross-functional teams to maintain subject safety, data integrity, and high-quality study execution.

Key Responsibilities
• Conduct site qualification, initiation, routine monitoring, and closeout visits.
• Provide sponsor oversight of investigational sites and CRO monitoring activities.
• Ensure compliance with ICH-GCP, FDA regulations, study protocols, and SOPs.
• Review informed consent, subject eligibility, safety reporting, and investigational product management.
• Identify, escalate, and resolve site quality, compliance, and operational risks.
• Collaborate with Clinical Trial Managers, CROs, Data Management, Medical Monitoring, and Pharmacovigilance teams.
• Support study start-up, site activation, enrollment, and inspection readiness.
• Maintain accurate monitoring reports and study documentation.
• Travel to investigative sites as required.

Required Qualifications
• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field.
• 5+ years of Clinical Research Associate (CRA) monitoring experience.
• Hands-on Phase I Oncology monitoring experience is required.
• Experience with dose-escalation studies and early-phase oncology trials.
• Strong knowledge of ICH-GCP, FDA regulations, EDC, CTMS, and eTMF.
• Excellent communication, problem-solving, and organizational skills.
• Willingness to travel regularly for site monitoring.

Preferred Qualifications
• Sponsor-side or sponsor-dedicated CRA experience.
• Experience monitoring NCI-sponsored, cooperative group, or academic oncology studies.
• Experience working with CRO partners and cross-functional clinical teams.