As a Lead Clinical Research Associate, you will hold a leadership role within the study team, overseeing and guiding the clinical team while driving trial activities at a country or regional level. You will ensure high-quality execution, compliance, and timely delivery. You will act as a key point of coordination across cross-functional teams.

This role focuses on leadership, mentorship, oversight, and consistency in monitoring practices rather than direct site management, with minimal to no site assignments and a low-travel model, emphasizing remote oversight and overall study quality.

Responsibilities:

- Monitors project timelines, patient enrollment, data cleaning, and ensuring compliance while implementing respective corrective and preventive measures.
- Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
- Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
- Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.
- Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
- Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.
- Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s)



and clinical study supplies on a country/region level.
- Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
- Ensures data integrity and compliance at a site level.
- Collaborates with investigator/ site feasibility and identification process, as well as study startup.
- Manages Monitors in the query resolution process, including Central Monitoring observations.
- Coordinates safety information flow and protocol/process deviation reporting.

- Experience with all types of monitoring visits in Phase II and/or III.
- Strong experience in Oncology preferred.
- Experience in Radiation Therapy or Radiopharmaceuticals, CAR-T Therapy or other types of Cell Therapy, Gene Therapy, or Nuclear Medicine is preferred.
- Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred.
- 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.

Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company that puts its people first.

PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

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📌 Lead Clinical Research Associate (México)
🏢 Visa Hunt
📍 México