Clinical Research Associate 3

Role overview

The Clinical Research Associate 3 will act as a sponsor-side clinical operations representative, overseeing investigative sites and helping ensure strong execution of Phase 1 oncology studies, with additional therapeutic area monitoring considered an advantage. This is a 12-month contract role with a possibility of becoming temporary-to-permanent. The assignment is based in Durham, North Carolina, with a first-shift schedule and an expected workload of roughly 20 to 30 hours per week. The pay range is $50 to $62 per hour, and the start date is as soon as possible.

What the role involves

This position blends conventional site monitoring with broader sponsor oversight. The selected professional will monitor site performance, watch for operational and quality risks, and work closely with CRO partners, vendors, and internal teams to address issues that could affect patient safety, data quality, protocol adherence, or timelines. Strong judgment in early-phase oncology, including dose-escalation studies and complex treatment regimens, is essential.

Key duties

• Represent the sponsor as the main contact for assigned sites and provide oversight of site conduct, protocol execution, and study progress across the full trial lifecycle.
• Perform both onsite and remote monitoring for Phase 1 oncology trials, covering qualification, initiation, routine monitoring, and closeout activities in line with the monitoring plan, sponsor procedures, ICH/GCP, and regulatory requirements.
• Oversee critical study areas such as informed consent, eligibility checks, treatment administration, dose-escalation decisions, safety reporting, investigational product handling, protocol deviations, and data integrity.
• Assess site readiness, performance, and quality trends using monitoring findings, study metrics, and ongoing site interactions to identify current or emerging risks.
• Raise significant site issues, quality concerns, and compliance risks promptly, and work with the Clinical Trial Manager and study team on corrective and preventive actions.
• Coordinate with CRO monitors, vendors, data management, medical monitoring, pharmacovigilance, clinical scientists, and study management to keep site status and priorities aligned.
• Review CRO monitoring delivery when applicable, including quality of monitoring, timeliness of follow-up, escalation of issues, and adequacy of site action plans.
• Check source-aligned and site-level information to confirm that patient safety, protocol compliance, and key study endpoints are being managed appropriately, especially in complex early-phase oncology settings.
• Support site feasibility, activation readiness, training, enrollment oversight, and ongoing engagement during study start-up and maintenance.
• Track site issues, protocol deviations, queries, action items, and inspection-readiness tasks through closure, with proper documentation and communication.
• Draft and/or review monitoring notes, visit reports, follow-up correspondence, and oversight records for accuracy, consistency, and compliance.
• Help maintain audit and inspection readiness by ensuring sponsor oversight and site-facing activities are documented, trended, escalated, and resolved on time.
• Develop effective working relationships with investigators, research nurses, coordinators, pharmacists, and site leadership while maintaining sponsor expectations for quality and performance.
• Use oncology monitoring experience to evaluate patient safety, site capability, protocol complexity, and operational execution in Phase 1 and other early-phase oncology studies.
• Travel to sites as needed to support field monitoring and sponsor oversight responsibilities.

Experience and qualifications

• A bachelor’s degree in life sciences, nursing, pharmacy, or another related scientific discipline is preferred.
• At least 5 years of clinical monitoring experience is required, with a strong background in oncology monitoring.
• Hands-on Phase 1 oncology monitoring experience is required, including dose-escalation studies, complex eligibility and safety assessments, and early-phase operational challenges.
• Prior experience in a sponsor-side or sponsor-dedicated CRA role is preferred, along with the ability to think and act from a sponsor perspective.
• Experience with NCI-sponsored studies, cooperative group studies, or academic oncology research networks is preferred.
• Working knowledge of ICH/GCP guidance, FDA regulations, and sponsor oversight expectations is required, including the ability to spot and escalate risks tied to subject safety, data integrity, and protocol compliance.
• Experience collaborating with CRO partners and cross-functional study teams, with strong communication and issue-resolution skills.
• Familiarity with EDC, CTMS, eTMF, and study tracking tools, and the ability to use study data and metrics to assess site status.
• Strong written and verbal communication skills for documenting findings, summarizing issues, and sharing risks and recommendations clearly.
• Ability to identify problems, apply critical thinking, drive follow-up to closure, and support inspection-ready study conduct.
• Willingness and ability to travel regularly for onsite monitoring and sponsor oversight.

Schedule and engagement details

The current estimate for this contract is approximately 20 to 30 hours per week. The shift is first shift. This role is expected to involve travel to investigative sites as required. The assignment is described as a 12-month contract with potential temporary-to-permanent conversion.

Compensation

The hourly pay rate is $50 to $62 per hour.