Senior Clinical Research Associate

PSI CRO

About The Position

The Senior Clinical Research Associate conducts and reports clinical trial monitoring activities, manages site communications and study progress, and supports complex studies. The role also trains, mentors, and supervises junior CRAs on study-level responsibilities, while delivering training to investigators, site staff, and project teams. It offers opportunities to develop as a trainer, mentor, and leader, with potential progression toward Lead Monitor roles.

Requirements

College or university degree in Life Sciences, or an equivalent combination of education, training, and experience.
Full working proficiency in Spanish and English.
At least 3 years of independent on-site monitoring experience in Mexico.
Experience with all types of monitoring visits in Phase II and/or III.
Availability to travel.
Proficiency in MS Office applications.
Ability to plan and work in a dynamic team environment.
Communication, collaboration, and problem-solving skills.

Nice To Haves

Experience in Oncology or Infectious Diseases.

Responsibilities

Train, mentor, and supervise junior CRAs on study-level responsibilities.
Prepare for, conduct, and report selection, initiation, routine, and closeout monitoring visits.
Deliver training to investigators, site staff, and project teams.
Work on complex studies.
Perform CRF review, source document verification, and query resolution.
Manage site communications.
Participate in site identification.
Serve as a contact for clinical investigators, vendors, and support services regarding study progress.
Participate in feasibility research.
Prepare and deliver presentations at Investigator’s Meetings.
Prepare for and attend company audits, and resolve audit findings.
Support Regulatory Affairs in obtaining site regulatory documents.
Maintain study-specific automated tracking systems.