Senior Clinical Research Associate

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Research Associate based in United States.

The Senior Clinical Research Associate will play a key role in supporting the successful execution of multi-center clinical trials across the United States and/or globally. Working closely with Clinical Trial Managers, Study Directors, Medical Monitors, CROs, vendors, and clinical sites, this role provides hands-on operational oversight throughout the study lifecycle. You will help ensure trial activities are delivered on time, in compliance with GCP, ICH guidelines, regulatory requirements, and established procedures. The position combines site monitoring, vendor management, data review, documentation, and cross-functional coordination. You will also contribute to study planning and materials while mentoring junior clinical research professionals. This is an opportunity to make a meaningful contribution to innovative clinical development programs in solid tumors and cell therapy.

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.