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 (Xico)
🏢 Visa Hunt
📍 Xico