Lead Clinical Research Associate

Accountabilities: Coordinate investigator and site feasibility activities, site identification, and study start-up processes to ensure successful trial initiation.

Manage clinical project timelines, patient enrollment goals, and corrective or preventive actions to maintain study performance.

Review monitoring visit reports, ensure compliance with reporting requirements, and support monitors in resolving queries and observations.

Act as a central communication point between Clinical Research Associates, Site Management Associates, Project Managers, and regional leadership teams.

Coordinate and oversee monitoring activities, including site selection, initiation, routine monitoring, closeout visits, and supervised monitoring visits.

Ensure data integrity, regulatory compliance, protocol adherence, and proper management of study risks at country and site levels.

Support site audits, inspection readiness activities, CAPA development, and resolution of audit findings.

Manage clinical supplies, investigational products, documentation flows, and reconciliation processes across assigned studies.

Lead country-level project team meetings, provide status updates, and maintain accurate tracking systems and reporting documentation.

Deliver project-specific training, mentor monitors and newly promoted Lead Clinical Research Associates, and support investigator training initiatives.

Collaborate with internal teams and external stakeholders to improve clinical trial execution, communication, and operational efficiency.

Requirements

Relevant academic background in Life Sciences, Medicine, Pharmacy, Nursing, or a related discipline, or an equivalent combination of education and experience.

Minimum of 4 years of site monitoring experience with involvement in global clinical trials as a Lead Monitor or equivalent role.

Proven experience managing clinical trial sites and CRAs, with strong knowledge of Canadian and US regulatory guidelines and clinical research practices.

Experience conducting and overseeing Phase I–III monitoring activities.

Strong therapeutic experience in oncology is preferred.

Experience in advanced therapies such as CAR-T therapy, cell therapy, gene therapy, radiation therapy, radiopharmaceuticals, or nuclear medicine is an asset.

Experience in gastrointestinal indications, including Crohn’s disease, ulcerative colitis, or IBS, is an advantage.

Excellent communication, collaboration, and problem-solving skills with the ability to work effectively across multidisciplinary teams.

Strong organizational skills with the ability to manage multiple priorities in a fast-paced clinical environment.

Proficiency in Microsoft Office applications and clinical trial management systems.

Full professional proficiency in English.

Willingness and ability to travel up to 65% depending on project requirements.

Valid driver’s license where applicable.

Benefits

Opportunity to advance your career within a growing global clinical research environment.

Exposure to diverse therapeutic areas and complex international clinical trials.

Continuous learning opportunities and professional development support.

Collaborative workplace culture focused on innovation, quality, and teamwork.

Opportunity to make a meaningful contribution to medical research and patient outcomes.

Dynamic role with significant ownership, responsibility, and career growth potential.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether? 

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

#LI-CL1