Lead Clinical Research Associate

Psi CRO; Santiago; Híbrido; CLP 71.702.000 - 105.163.000; Jornada completa

Descripción de la vacante

PSI CRO Chile is seeking a Lead Clinical Research Associate to guide the clinical team and drive trial activities at country level, with leadership, mentorship and oversight of monitoring practices. The role emphasizes remote oversight and minimal site management, focusing on overall study quality and compliance.

You will monitor timelines and patient enrollment, coordinate cross-functional teams, deliver training and reports, and support CAPA processes, site audits, and risk management across

Formación

• Minimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor.
• Experience monitoring sites in the US.
• Experience with all types of monitoring visits in Phase II and/or III.
• Strong working proficiency in English.
• Proficiency in MS Office applications.
• Ability to travel.

Responsabilidades

• Monitors project timelines, patient enrollment, data cleaning and ensuring compliance.
• Reviews monitoring visit reports for all visit types and ensures reporting compliance.
• 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 and provides status updates and reports.
• Provides project-specific training and prepares training materials for the project team under supervision.
• Supervises source data verification and follows up on data queries at site level in the country/region.
• Ensures data integrity and compliance at a site level.
• Collaborates with investigator/site feasibility and identification process, as well as study startup.

Conocimientos

MS Office

English proficiency

Ability to travel

Educación

MD

MPharm

RN

Life Sciences degree

Descripción del empleo

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.

Job Description

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 providesstatus 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.

Qualifications

• Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.
• Minimum of 4years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalentqualification level.
• Experience monitoring sites in the US.
• 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.

Additional Information

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.