Lead Clinical Research Associate

Visa Hunt; México; Presencial; MXN 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

PSI, a leading Contract Research Organization with over 30 years in the industry, is seeking a Lead Clinical Research Associate. This role emphasizes leadership, mentorship, and oversight of monitoring practices with remote oversight and minimal site assignments.

You will guide the clinical team, ensure quality, compliance, and timely delivery across country/region trials, and coordinate cross-functional communication while supporting study startup and risk management.

Formación

• Experience supervising Phase II/III monitoring activities.
• Strong communication and leadership in multi-disciplinary teams.
• Proven ability to ensure data integrity and regulatory compliance.
• Remote oversight with travel as needed.
• Experience in oncology or related therapies is preferred.

Responsabilidades

• Oversee and guide the clinical team to ensure timely trial activities.
• Monitor timelines, patient enrollment, data cleaning, and CAPA.
• Coordinate communication between monitors, PM, and regional leads.
• Lead country-level project team calls and provide status reports.
• Provide training materials and supervise ISF/TMF reconciliation.
• Ensure drug accountability and safety information flow.
• Support study startup activities and feasibility with investigators.
• Manage monitoring visits and report review for region.

Conocimientos

Leadership

Mentorship

Cross-functional collaboration

Regulatory compliance

Communication

MS Office

Travel

Herramientas

MS Office

Descripción del empleo

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.