Lead Clinical Research Associate (Burzaco)

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
- Coordinates investigator/ site feasibility and identification process, as well as study startup.
- Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.
- Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
- 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.
- Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
- Coordinates planning of supervised monitoring visits and conducts the visits.
- Manages the project team in site contracting and payments.
- Leads project team calls on a country level as well as providesstatus updates and reports to Regional Lead/ Project Manager.
- 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.
- Provides project-specific training and prepares training materials for the project team under supervision of a Project Postúlate en Kit Empleo: kitempleo.com.ar/empleo/qav5v