Lead Clinical Research Associate

As a Lead Clinical Research Associate, you will oversee clinical trial activities at a country or regional level, ensuring effective coordination, compliance, and high-quality execution. Your responsibilities will include:

• Providing leadership and guidance to clinical monitoring teams, supporting consistent monitoring practices and operational excellence.


• Monitoring study timelines, enrollment progress, data cleaning activities, and compliance requirements while implementing corrective and preventive actions when needed.


• Reviewing monitoring visit reports and ensuring quality, accuracy, and reporting compliance across assigned regions.


• Acting as a key communication point between Clinical Research Associates, Site Management Associates, Project Leads, and Project Managers.


• Leading country-level project meetings, providing study updates, identifying risks, and escalating operational challenges.


• Delivering project-specific training, preparing training materials, and mentoring clinical team members, including newly promoted Lead CRAs.


• Supporting site feasibility, study startup activities, investigator relationships, and regulatory or ethics committee submission processes.


• Supervising source data verification, query resolution, data integrity checks, and protocol compliance activities.


• Managing study risks, deviations, audit preparation activities, CAPA development, and implementation follow-up.


• Ensuring appropriate management, reconciliation, and tracking of investigational products, clinical supplies, and essential study documentation.


• Supporting site contracting, payment coordination, and vendor collaboration at country and regional levels.


• Ensuring timely updates of clinical trial tracking systems, documentation repositories, and required operational records.


• Supporting investigator meetings, site training sessions, and communication of safety information and protocol requirements.


• Maintaining strong collaboration with global and regional stakeholders to ensure successful trial delivery.

Requirements:

The ideal candidate brings strong clinical research experience, leadership capabilities, and a proven ability to support complex global trials. Required qualifications include:

• Relevant academic background in Life Sciences, Medicine, Pharmacy, Nursing, or an equivalent combination of education, training, and experience.


• Minimum of 4 years of site monitoring experience within global clinical research projects, with experience as a Lead CRA or equivalent role.


• Experience monitoring clinical trial sites in the United States.


• Experience conducting different types of monitoring visits across Phase II and/or Phase III studies.


• Strong knowledge of clinical trial processes, regulatory requirements, compliance standards, and quality management practices.


• Experience in therapeutic areas such as Oncology is strongly preferred.


• Previous exposure to Radiation Therapy, Radiopharmaceuticals, CAR-T Therapy, Cell Therapy, Gene Therapy, Nuclear Medicine, or related advanced therapies is preferred.


• Experience in gastrointestinal therapeutic areas such as Crohn’s disease, Ulcerative Colitis, or IBS is an advantage.


• Full professional proficiency in English.


• Strong knowledge of Microsoft Office applications.


• Excellent communication, collaboration, organizational, and problem-solving skills.


• Ability to manage multiple priorities, work independently, and succeed in a dynamic international environment.


• Willingness and ability to travel when required.

Benefits:

This opportunity provides the chance to grow within a global clinical research environment while contributing to meaningful healthcare advancements. Benefits include:

• Opportunity to advance your career in clinical research with global study exposure.


• Leadership role focused on mentorship, coordination, and strategic oversight.


• Low-travel model focused on remote study oversight and operational excellence.


• Exposure to innovative therapeutic areas and complex clinical development programs.


• Opportunity to collaborate with international teams and industry experts.


• Continuous learning opportunities and professional development support.


• Dynamic environment focused on quality, innovation, and employee growth.