Clinical Research Associate - Oncology

Role overview

This contract opportunity is for an experienced Clinical Research Associate focused on early-phase oncology studies. The assignment is based in Durham, NC and runs for 12 months. The position calls for strong Phase I monitoring expertise, a sponsor-oriented approach, and a consistent focus on participant safety, data quality, and regulatory adherence across the study lifecycle.

What you will do

• Perform both on-site and remote monitoring activities for Phase I oncology trials while ensuring alignment with the protocol, ICH-GCP standards, and FDA requirements.
• Oversee dose-escalation studies, assess complex eligibility criteria, monitor safety, and manage early-stage trial operations.
• Protect subject safety, protocol compliance, and data accuracy by spotting, documenting, and escalating risks in a timely manner.
• Check source records, confirm the accuracy of clinical data, and drive prompt closure of outstanding data queries.
• Work closely with sponsors, CROs, investigators, and other study partners to resolve operational issues and keep milestones on track.
• Provide sponsor-level oversight by evaluating site performance, flagging risk areas, and advising on corrective and preventive actions.
• Keep trial records complete and inspection-ready in EDC, CTMS, eTMF, and related clinical systems.
• Monitor study progress through metrics and site performance data to support informed decisions.
• Draft thorough monitoring reports, communicate observations clearly, and follow through on action items.
• Assist with regulatory inspections and audits by maintaining sponsor and regulatory compliance.
• Travel regularly to research sites for monitoring and oversight work.

What the employer is looking for

• A bachelor’s degree in Life Sciences, Nursing, Pharmacy, or another related scientific field is preferred.
• At least 5 years of clinical monitoring experience, with strong experience in oncology studies.
• Hands-on Phase I oncology monitoring experience covering dose escalation, complex eligibility review, safety oversight, and early-phase operational challenges.
• Solid working knowledge of ICH-GCP guidelines, FDA regulations, and sponsor oversight expectations.
• Ability to identify, evaluate, and escalate risks involving participant safety, protocol compliance, and data integrity.
• Experience with EDC, CTMS, eTMF, and other clinical trial management platforms.
• Strong analytical thinking, documentation, communication, and problem-solving skills.
• Comfort working independently while coordinating effectively with cross-functional teams.
• Willingness to travel frequently for site monitoring and oversight responsibilities.
• Preference for candidates with sponsor-side or sponsor-dedicated CRA experience.
• Helpful background includes monitoring NCI-sponsored studies, cooperative group studies, or academic oncology research networks.
• Experience working with CRO partners and cross-functional study teams is a plus.
• Strong inspection-readiness and audit-support experience is preferred.

Additional details

This is a remote contract role tied to Durham, NC. The assignment duration is 12 months. The role is not presented as an internship, and no stipend or salary amount was provided in the source information.