Lead Clinical Research Associate

PSI CRO·Lima, Callao Region, Peru

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About the role

PSI seeks a Lead Clinical Research Associate in Lima to provide country or regional leadership for clinical trials. The role emphasizes oversight, mentoring, monitoring consistency, compliance, data integrity, study coordination, and low-travel remote oversight, with minimal to no site assignments. Applicants need at least four years of site monitoring experience, global project participation, US site monitoring experience, and Phase II and/or III monitoring experience.

Key requirements

• Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.
• At least 4 years of relevant experience
• Required skills: site monitoring, global clinical projects, monitoring visits in the US, Phase II and/or III monitoring, English proficiency, MS Office, planning and multitasking, communication, collaboration, problem-solving
• Required language: English

Opportunity details

• Workplace: Hybrid
• Posted: Aug 4, 2026
• Original advert language: English

Full vacancy

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Employer’s role description

Job title: Lead Clinical Research Associate

Location: Lima, Callao Region, Peru

Employment type: Full-time

Company Description

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.

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.
Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.
Oversees project team in CAPA development and implementation.
Coordinates project team in process deviations review, management and reporting.
Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.
Delivers trainings and presentations at Investigator Meetings.
Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.
Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
Supports preparation of draft regulatory and ethics committee submission packages.

Lead Clinical Research Associate

About the role

Key requirements

Opportunity details

Full vacancy

Company Description

Job Description

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