Lead Clinical Research Associate

We are the company that cares - for our staff, our clients, our partners, and the quality of the work we do.

Founded in 1995, PSI CRO is a privately owned, global Contract Research Organization with more than 3,000 employees dedicated to advancing medical science and bringing new therapies to patients worldwide.

In an industry shaped by mergers, acquisitions, and restructures, PSI stands apart. We have remained privately held, have never undergone a merger or acquisition, and have never experienced company-wide layoffs. Our long-term stability allows us to invest in our people, foster meaningful careers, and build lasting partnerships with our clients.

If you're looking for a collaborative organization where you can continue to grow while making a meaningful impact, PSI is the right place for you.

As a Lead Clinical Research Associate, you'll provide leadership, oversight, and mentorship across regional clinical trials while partnering closely with Project Managers, Regional Project Leads, CRAs, and cross-functional teams to ensure high-quality study execution.

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.

Performs clinical supplies management with vendors on a country and regional level.

Ensures study-specific and corporate tracking systems are updated in a timely manner.

Coordinates planning of supervised monitoring visits and conducts the visits. 

Manages the project team in site contracting and payments.

Ensures ongoing evaluation of data integrity and compliance at a country/regional level.