Lead Clinical Research Associate

Accountabilities:
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.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.