Lead Clinical Research Associate

About This Opportunity

We are representing a confidential contract research organization seeking a Lead Clinical Research Associate based in Colombia. This is a leadership position focused on overseeing clinical trial activities at the country or regional level, with emphasis on remote oversight, team mentorship, and study quality rather than direct site management.

In this role, you will guide monitoring teams, coordinate cross-functional stakeholders, and ensure compliance and timely delivery across clinical research projects. This is a low-travel model with minimal site assignments, ideal for an experienced CRA ready to step into strategic oversight and team leadership.

Responsibilities

• Monitor project timelines, patient enrollment, data cleaning, and compliance; implement corrective and preventive measures as needed
• Review monitoring visit reports across all visit types and ensure reporting compliance from monitors in your region
• Serve as the main communication liaison between monitors, site management associates, regional project leads, and project managers
• Lead project team calls at the country level and provide regular status updates and reports to regional leadership
• Develop project-specific training materials and deliver training to project teams under supervision of project management
• Supervise source data verification, follow up on data queries, and review and manage study risks at the site level
• Ensure proper handling, accountability, reconciliation, and return of investigational products and clinical study supplies across your country or region
• Review essential study documents and supervise reconciliation of Investigator Site Files (ISF) and Trial Master Files (TMF)
• Ensure data integrity and compliance at the site level throughout the study lifecycle
• Collaborate on investigator and site feasibility, identification, and study startup processes
• Manage monitors in the query resolution process, including central monitoring observations
• Coordinate safety information flow and protocol/process deviation reporting
• Perform clinical supplies management with vendors at country and regional levels
• Ensure study-specific and corporate tracking systems are updated in a timely manner
• Plan and conduct supervised monitoring visits; coordinate site contracting and payment processes
• Conduct site audit preparation visits, participate in audits as needed, and coordinate resolution of audit findings
• Oversee CAPA development and implementation; coordinate process deviation review, management, and reporting
• Conduct initial training and authorization monitoring visits for monitors; mentor newly promoted Lead CRAs
• Deliver trainings and presentations at Investigator Meetings
• Ensure subject recruitment targets and project timelines are properly defined, communicated, and met
• Supervise Site Management Associates in document and laboratory supply flow between sites and central labs or reviewers
• Support preparation of draft regulatory and ethics committee submission packages

What We're Looking For

• Relevant educational background such as MD, MPharm, RN, or college/university degree in Life Sciences, or an equivalent combination of education, training, and experience
• Minimum 4 years of site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level
• Experience monitoring sites in the United States
• Experience with all types of monitoring visits in Phase II and/or Phase III trials
• Strong experience in Oncology preferred
• Experience in Radiation Therapy, Radiopharmaceuticals, CAR-T Therapy, other Cell Therapy, Gene Therapy, or Nuclear Medicine is preferred
• Strong experience in gastrointestinal indications (Crohn's, Ulcerative Colitis, IBS) preferred
• Full working proficiency in English (written and spoken)
• Proficiency in MS Office applications
• Ability to plan, multitask, and work effectively in a dynamic team environment
• Excellent communication, collaboration, and problem-solving skills
• Ability to travel as needed (low-travel model)

How We Work With You

Candidates apply directly through Get A Job.ai. Our recruitment team will review your application and conduct an initial screening. Qualified candidates will be submitted to our client for consideration. Please do not contact the client directly—all communication flows through our talent team to ensure a smooth and professional process.

Pay

Compensation details will be discussed with qualified candidates during the screening process.

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