Job Title : Clinical Research Associate/Clinical Monitor

Location : Durham, NC 27701

Duration : 12+ Months

Pay Rate : $60/HR On W2 (No Benefits)

Primary Responsibilities:

Serve as the sponsor-side point of contact for assigned sites, providing direct oversight of site performance, protocol execution, and overall study conduct throughout the trial lifecycle.

Conduct on-site and remote monitoring activities for Phase 1 oncology studies, including site qualification, initiation, routine monitoring, and closeout visits, in alignment with the monitoring plan, sponsor SOPs, ICH/GCP, and applicable regulations.

Provide sponsor oversight of critical study processes, including informed consent, eligibility confirmation, treatment administration, dose-escalation decisions, safety reporting, investigational product handling, protocol deviations, and data quality.

Evaluate site performance, operational readiness, and quality trends using monitoring observations, study metrics, and site interactions to identify actual or emerging risks.

Escalate significant site issues, quality concerns, and compliance risks in a timely manner, and partner with the Clinical Trial Manager and broader study team on mitigation strategies and follow-up actions.

Collaborate closely with CRO monitors, vendors, data management, medical monitoring, pharmacovigilance, clinical scientists, and study management to ensure alignment on site status, issues, and study priorities.

Qualifications, Knowledge, Skills and Abilities:

Bachelor's degree in life sciences, nursing, pharmacy, or a related scientific field preferred.

Minimum of 5 years of clinical monitoring experience, with strong oncology monitoring experience required. Direct Phase 1 oncology monitoring experience is required, including experience with 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; candidates should demonstrate the ability to operate with a sponsor mindset and exercise sound judgment beyond routine monitoring activities.

Experience monitoring NCI-sponsored studies, cooperative group studies, or academic oncology research networks is preferred.

Strong working knowledge of ICH/GCP guidelines, FDA regulations, and sponsor oversight expectations, including the ability to recognize and escalate risks related to subject safety, data integrity, and protocol compliance.

Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.