Clinical Research Associate

Clinical Research Associate (CRA)

The Clinical Research Associate (CRA) serves as a sponsor-side clinical operations representative responsible for oversight of investigational sites and support of high-quality study execution across Phase 1 oncology trials (required) plus other therapeutic areas monitoring oversight a plus. This role combines traditional site monitoring responsibilities with broader sponsor oversight activities, including identification of operational and quality risks, collaboration with CRO partners and vendors, and proactive escalation of issues that may affect subject safety, data integrity, protocol compliance, or study timelines. The CRA is expected to apply strong clinical judgment in early-phase oncology settings, including dose-escalation and complex treatment protocols, while building effective relationships with sites and internal cross-functional teams. Experience monitoring National Cancer Institute (NCI) studies, cooperative group studies, or other academically complex oncology trials is strongly preferred. This is a contract traveling CRA position, as needed.

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.
• Provide sponsor-level oversight of CRO-delivered monitoring activities, as applicable, including review of monitoring quality, timeliness of follow-up, issue escalation, and adequacy of site action plans.
• Review source-oriented and site-level information to confirm that subject safety, protocol compliance, and key study endpoints are being managed appropriately, with particular attention to the complexity of early-phase oncology trials.
• Support study start-up and maintenance activities by contributing to site feasibility, site activation readiness, training, enrollment oversight, and ongoing site engagement.
• Track and follow critical site issues, protocol deviations, data queries, action items, and inspection readiness activities to resolution, ensuring appropriate documentation and communication across stakeholders.
• Prepare and/or review monitoring documentation, visit reports, follow-up communications, and study oversight documentation to ensure accuracy, consistency, and compliance with sponsor expectations.
• Contribute to audit and inspection readiness by ensuring site-facing and sponsor oversight activities are documented appropriately and that issues are identified, trended, escalated, and resolved in a timely manner.
• Build strong working relationships with investigators, research nurses, study coordinators, pharmacists, and site leadership while maintaining clear sponsor expectations for quality and performance.
• Apply prior oncology monitoring experience to assess patient safety considerations, site capabilities, protocol complexity, and operational execution in Phase 1 and other early-phase oncology settings.
• Experience monitoring National Cancer Institute (NCI) studies, cooperative group studies, or federally sponsored oncology trials is a strong plus, particularly in environments with complex institutional processes and academic site infrastructure.
• Travel to investigative sites as required to support sponsor-side field monitoring and oversight responsibilities.

Qualifications:

• 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. • Experience working with CRO partners and cross-functional study teams, with the ability to communicate clearly, influence effectively, and drive issue resolution across multiple stakeholders. • Experience with EDC systems, CTMS, eTMF, and study tracking tools, with the ability to use study information and metrics to assess site status and support oversight. • Strong written and verbal communication skills, with the ability to clearly document findings, synthesize issues, and communicate risks and recommendations to internal and external stakeholders. • Demonstrated ability to identify issues, apply critical thinking, drive follow-up to resolution, and support inspection-ready study conduct. • Willingness and ability to travel regularly for on-site monitoring and sponsor oversight activities.