16 sep
|
Visa Hunt
|
Ciudad de México
16 sep
Visa Hunt
Ciudad de México
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 Mo
📌 Lead Clinical Research Associate (Ciudad de México)
🏢 Visa Hunt
📍 Ciudad de México