The Clinical Research Associate (CRA) serves as a sponsor-side clinical operations professional responsible for overseeing investigational sites and ensuring the successful execution of high-quality clinical trials, with a primary focus on Phase 1 oncology studies. Experience supporting additional therapeutic areas and providing monitoring oversight is highly desirable.

This role combines hands-on site monitoring with broader sponsor oversight responsibilities, including risk identification, quality management, vendor and CRO collaboration, and proactive issue escalation. The CRA plays a critical role in safeguarding patient safety, ensuring protocol compliance, maintaining data integrity, and supporting study timelines. The ideal candidate possesses strong clinical and operational expertise in early-phase oncology, including dose-escalation studies and complex treatment protocols, and is skilled at building productive relationships with investigative sites and cross-functional stakeholders.

Experience monitoring National Cancer Institute (NCI)-sponsored studies, cooperative group trials, or other academically complex oncology studies is strongly preferred.

This is a contract-based, travel-focused CRA position with travel required as needed to support monitoring and sponsor oversight activities.
Key Responsibilities
• Act as the primary sponsor representative for assigned investigative sites, providing oversight of site performance, protocol adherence, and overall study conduct throughout the clinical trial lifecycle.
• Perform on-site and remote monitoring activities for Phase 1 oncology studies, including site qualification, site initiation, interim monitoring, and closeout visits, in accordance with study monitoring plans, sponsor SOPs, ICH/GCP guidelines, and regulatory requirements.
• Oversee critical study activities, including informed consent, eligibility verification, treatment administration, dose-escalation decisions, safety reporting, investigational product accountability, protocol deviation management, and data quality review.
• Assess site performance, operational readiness, and quality trends through monitoring observations, site interactions, and study metrics to proactively identify emerging risks and areas requiring intervention.
• Escalate significant compliance, quality, and operational issues in a timely manner and partner with Clinical Trial Managers and study teams to implement effective mitigation and corrective action plans.
• Collaborate closely with CRO personnel, vendors, medical monitors, pharmacovigilance, data management, clinical scientists, and study management teams to ensure alignment on study priorities, site status, and issue resolution.
• Provide oversight of CRO-delivered monitoring activities, including evaluation of monitoring quality, timeliness of follow-up, issue escalation practices, and adequacy of corrective actions.
• Review source-level and site-level information to verify that subject safety, protocol compliance, and study endpoints are being appropriately managed, particularly within complex early-phase oncology environments.
• Support study start-up and site management efforts through feasibility assessments, activation readiness, site training, enrollment oversight, and ongoing site engagement.
• Track and drive resolution of critical site issues, protocol deviations, data queries, action items, and inspection readiness activities while ensuring appropriate documentation and stakeholder communication.
• Prepare, review, and maintain monitoring reports, follow-up correspondence, and sponsor oversight documentation to ensure accuracy, completeness, and regulatory compliance.
• Contribute to audit and inspection readiness by ensuring monitoring and oversight activities are well documented and that identified risks and findings are appropriately trended, escalated, and resolved.
• Develop and maintain strong working relationships with investigators, research nurses, study coordinators, pharmacists, and site leadership while promoting accountability for quality and performance.
• Leverage oncology monitoring expertise to evaluate patient safety considerations, protocol complexity, site capabilities, and operational execution across Phase 1 and other early-stage oncology trials.
• Apply experience with NCI-sponsored studies, cooperative group trials, or federally funded oncology research programs to effectively navigate complex academic and institutional research environments.
• Travel regularly to investigative sites to support sponsor monitoring, oversight, and relationship management activities.
Qualifications & ExperienceRequired Qualifications
• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline preferred.
• Minimum of five (5) years of clinical monitoring experience with significant oncology monitoring expertise.
• Direct Phase 1 oncology monitoring experience required, including dose-escalation studies, complex eligibility reviews, safety assessments, and early-phase clinical operations.
• Comprehensive knowledge of ICH/GCP guidelines, FDA regulations, and sponsor oversight requirements.
• Demonstrated ability to identify, assess, and escalate risks related to patient safety, data integrity, protocol compliance, and study quality.
• Experience with electronic data capture (EDC) systems, CTMS, eTMF platforms, and clinical trial tracking tools.
• Strong analytical, problem-solving, organizational, and critical-thinking skills.
• Excellent written and verbal communication skills with the ability to clearly communicate findings, risks, and recommendations to diverse stakeholders.
• Proven ability to manage complex issues through resolution while maintaining inspection-ready study conduct.
• Ability and willingness to travel regularly for site monitoring and sponsor oversight activities.
Preferred Qualifications
• Previous sponsor-side or sponsor-dedicated CRA experience with demonstrated ability to operate from a sponsor oversight perspective.
• Experience monitoring NCI-sponsored studies, cooperative group trials, academic oncology networks, or federally funded oncology research programs.
• Experience collaborating with CRO partners and cross-functional teams in a matrix environment.
• Ability to influence stakeholders, foster collaboration, and drive accountability across multiple study partners.

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com.