Lead Clinical Research Associate

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Lead Clinical Research Associate in the United States.

This role is a senior-level clinical operations position focused on leading and overseeing clinical trial monitoring activities across national or regional studies. You will act as a central coordination point within the study team, ensuring high-quality execution, regulatory compliance, and timely delivery of clinical trial milestones. The position emphasizes leadership, mentorship, and oversight rather than frequent site travel, with a strong focus on remote monitoring and study quality management. You will collaborate closely with monitors, project managers, and cross-functional stakeholders to ensure alignment across all study activities. In addition to operational oversight, you will contribute to training, risk management, and process improvement initiatives. This is a highly impactful role within a dynamic clinical research environment, ideal for an experienced professional ready to lead and shape study execution quality at scale.

• Lead and oversee clinical trial monitoring activities across assigned studies, ensuring adherence to timelines, enrollment targets, data quality standards, and regulatory compliance while implementing corrective and preventive actions when needed.
• Serve as a primary communication hub between monitors, site management teams, regional leads, and project managers, ensuring smooth coordination and issue resolution.
• Review monitoring visit reports and ensure consistency, completeness, and compliance across all monitoring activities within the region.
• Provide project-level training, develop training materials, and mentor monitors and junior team members, including newly promoted Lead CRAs.
• Supervise data integrity processes, including source data verification, query resolution, and risk identification at site and regional levels.
• Oversee investigational product handling, clinical supplies management, and reconciliation of essential study documents, including ISF/TMF compliance.
• Support study startup activities, feasibility assessments, site selection, audit preparation, CAPA development, and ongoing quality oversight of clinical trial processes.
• Coordinate safety reporting, protocol deviation management, vendor interactions, and ensure timely updates across study tracking systems.

Requirements:

• Degree in Life Sciences or a related field (MD, MPharm, RN, or equivalent combination of education and experience).
• Minimum of 4 years of clinical site monitoring experience, including participation in global clinical trials in a Lead CRA or equivalent role.
• Strong experience in Phase II and/or Phase III clinical trials with full understanding of all monitoring visit types.
• Preferred experience in Oncology, particularly in areas such as Radiation Therapy, Radiopharmaceuticals, CAR-T, Gene Therapy, or Nuclear Medicine.
• Additional therapeutic experience in gastrointestinal conditions (e.g., Crohn’s disease, ulcerative colitis, IBS) is highly valued.
• Strong understanding of clinical trial operations, regulatory requirements, and data integrity standards.
• Excellent communication, leadership, and problem-solving skills with the ability to mentor and coordinate cross-functional teams.
• Proficiency in MS Office and ability to manage multiple priorities in a dynamic, fast-paced environment.
• Willingness and ability to travel as required, with strong organizational and planning capabilities.

Benefits:

• Opportunity to work in a stable yet innovation-driven clinical research organization with a strong international presence.
• Leadership role with high visibility and impact across global clinical trial operations.
• Low-travel model with emphasis on remote oversight and work-life balance.
• Professional growth opportunities through mentorship responsibilities and leadership development.
• Exposure to advanced therapeutic areas such as oncology, gene therapy, and cell therapy.
• Collaborative and people-focused working culture with strong emphasis on quality and compliance.
• Competitive compensation package aligned with experience and responsibilities.