Senior Clinical Research Associate

Accountabilities: • Independently manage and support study start-up activities for multi-center clinical trials, coordinating required activities, documentation, timelines, and site readiness.

• Perform or support on-site feasibility, Site Initiation, Interim Monitoring, and Close-Out Visits alongside CRO CRAs to assess site and monitoring performance.

• Provide ongoing monitoring oversight by reviewing monitoring schedules, performance metrics, reports, and other indicators of site and CRO execution.

• Support clinical site training and monitor adherence to study protocols, ICH/GCP guidelines, applicable regulations, statutes, and standard operating procedures.

• Lead or participate in the management of clinical study vendors, including CROs, central laboratories, central imaging providers, and other external partners.

• Perform routine in-house data listing reviews and support the identification, investigation, and resolution of clinical data or operational issues.

• Collect, review, and monitor required regulatory documentation throughout study start-up, maintenance, and close-out to ensure complete and inspection-ready records.

• Partner with Clinical Trial Management and cross-functional teams on contracts, study logistics, patient enrollment, safety, data management, and other activities required for effective study execution.

• Contribute to the development and maintenance of protocols, informed consent documents, CRFs, monitoring conventions, tracking tools, and other clinical study materials.

• Support or lead day-to-day study operations, ensuring assigned activities remain aligned with project goals, timelines, quality standards, and applicable regulatory requirements.

• Mentor and coach junior clinical research professionals and contribute to their development through practical guidance and knowledge sharing.

• Identify opportunities to improve study execution and contribute hands-on to clinical development initiatives and other priorities as program needs evolve.

Requirements:

• Hold a BS/BA, RN, or equivalent qualification, with at least 4 years of clinical trial monitoring, clinical trial management, and vendor experience in environments governed by CFR, GCP, and ICH guidelines.

• Bring 8+ years of clinical operations experience, with experience in solid tumors or cell therapy strongly preferred.

• Demonstrate strong knowledge of ICH/GCP guidelines, clinical drug development processes, protocol requirements, study design, study planning, management, and monitoring practices.

• Have substantial experience managing clinical studies from early through late development phases and working effectively with CROs and other study vendors.

• Demonstrate excellent written and verbal communication, interpersonal, administrative, organizational, record-retention, and time-management skills.

• Possess strong decision-making, troubleshooting, problem-solving, analytical, and prioritization abilities, with the judgment and discretion required to manage multiple priorities and deadlines.

• Be highly proficient with Microsoft Word, PowerPoint, Excel, and Project, along with standard remote and office-based technology.

• Demonstrate strong written and spoken English skills and the ability to collaborate effectively with internal teams, clinical sites, CROs, vendors, and other stakeholders.

• Be comfortable taking a hands-on approach and independently contributing meaningful results within a research and development environment.

• Be able to work effectively in a professional or remote office environment and meet the physical and communication requirements associated with extended computer-based work.

• Be willing and able to travel up to 25% based on study and project requirements.

Benefits:

• Annual base salary of $130,000–$150,000 USD , with individual compensation determined by factors including location, role complexity, responsibilities, education, experience, and skills.

• Remote work environment with flexibility to perform the role from a professional home or office setting.

• Opportunities to contribute to innovative clinical development programs in solid tumors and cell therapy.

• Exposure to multi-center and global clinical trials, CRO and vendor management, site monitoring, and cross-functional clinical operations.

• Opportunities to develop expertise across the full clinical trial lifecycle, from study start-up through maintenance and close-out.

• Collaboration with experienced clinical, medical, data, vendor, and operational professionals in a multidisciplinary research environment.

• Opportunities to mentor junior team members while continuing to expand clinical research and operational expertise.

• Commitment to a diverse and inclusive professional environment, with reasonable accommodations available to support qualified individuals in performing the role.

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