Lead Clinical Research Associate

PSI CRO

3d

About The Position

The Lead Clinical Research Associate holds a leadership role within the study team, overseeing and guiding the clinical team and driving trial activities at a country or regional level. The role is responsible for high-quality execution, compliance, and timely delivery, and serves as a key coordination point across cross-functional teams. It emphasizes leadership, mentorship, oversight, and consistency in monitoring practices rather than direct site management. The position has minimal to no site assignments and a low-travel model, with an emphasis on remote oversight and overall study quality.

Requirements

• Relevant educational background, such as MD, MPharm, RN, or a College/University degree in Life Sciences, or an equivalent combination of education, training, and experience.
• At least 4 years of site monitoring experience, including participation in global clinical projects as a Lead Monitor or at an equivalent qualification level.
• Experience with all types of monitoring visits in Phase II and/or Phase III.
• Full working proficiency in English.
• Proficiency in MS Office applications.
• Ability to plan, multitask, and work in a dynamic team environment.
• Excellent communication, collaboration, and problem-solving skills.
• Ability to travel.

Nice To Haves

• Experience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or a rare disease indication.

Responsibilities

• Monitor project timelines, patient enrollment, data cleaning, and compliance, and implement corrective and preventive measures.
• Review monitoring visit reports for all visit types and ensure regional Monitor reporting compliance.
• Act as the main communication line between Monitors, Site Management Associates, the Regional Project Lead, and/or the Project Manager.
• Lead country-level project team calls and provide status updates and reports to the Regional Lead or Project Manager.
• Provide project-specific training and prepare training materials for the project team under the supervision of a Project Manager and Regional Project Lead.
• Supervise source data verification and follow up on site-level data queries in the country or region; review and manage site-level study risks.
• Ensure proper handling, use, accountability, reconciliation, and return of Investigational Products and clinical study supplies at country or regional level.
• Review essential study documents and supervise reconciliation of the Investigator Site File (ISF) and Trial Master File (TMF) at site and country or regional levels.
• Ensure site-level data integrity and compliance.
• Collaborate on investigator and site feasibility, identification, and study startup.
• Manage Monitors in the query resolution process, including Central Monitoring observations.
• Coordinate safety information flow and protocol or process deviation reporting.
• Manage clinical supplies with vendors at country and regional levels.
• Ensure study-specific and corporate tracking systems are updated in a timely manner.
• Coordinate planning of supervised monitoring visits and conduct visits.
• Manage the project team in site contracting and payments.
• Ensure ongoing evaluation of data integrity and compliance at country or regional level.
• Conduct site audit preparation visits, participate in site audits when applicable, and coordinate resolution of site audit findings at country or regional level.
• Oversee the project team in CAPA development and implementation.
• Coordinate project team review, management, and reporting of process deviations.
• Conduct initial training and authorization monitoring visits for Monitors and mentor newly promoted Lead CRAs.
• Deliver training and presentations at Investigator Meetings.
• Ensure subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
• Ensure accurate and timely information flow with trial sites regarding Adverse Events and protocol or process deviations.
• Supervise Site Management Associates in the flow of documents and laboratory supplies between sites and the Central or Regional Lab or Central Reviewer.
• Support preparation of draft regulatory and ethics committee submission packages.

Benefits

• Stable and secure workplace.
• Opportunity to advance a career in clinical research, coordinate a variety of tasks, learn new things, and grow with a company that puts its people first.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior