In-House Clinical Research Associate II (Medtech)

TL;DR

In-House Clinical Research Associate II (Medtech): Supporting clinical study sites and project teams by managing essential documentation, tracking milestones, and ensuring regulatory compliance with an accent on ICH-GCP standards. Focus on maintaining trial master files, facilitating site communication, and coordinating clinical system data to ensure study integrity across the LATAM region.

Location: Must be based in Mexico, Brazil, Argentina, Colombia, Chile, or Peru

Company

hirify.global is a global organization providing specialized services to the life sciences industry to accelerate the development of new therapies.

What you will do

• Assist with investigator recruitment and site feasibility activities.
• Maintain and distribute Investigator Site Files and ensure data accuracy in the Trial Master File (TMF).
• Act as the primary point of contact for study sites, addressing management issues and supply logistics.
• Track study milestones and activities using the Clinical Trial Management System (CTMS).
• Ensure timely data entry by sites in EDC systems and facilitate database closure procedures.
• Support CRA activities and regulatory submissions in compliance with ICH-GCP guidelines.

Requirements

• Must be based in Mexico, Brazil, Argentina, Colombia, Chile, or Peru.
• Bachelor's degree or international equivalent in a scientific or healthcare discipline.
• Minimum of 2 years of relevant clinical research experience.
• Fluency in English communication, both verbal and written.
• Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Working knowledge of the drug development process and ICH-GCP regulations.

Culture & Benefits

• Opportunity to build the foundation of a new regional function in LATAM.
• Professional development through mentorship and independent project work.
• Collaborative environment focused on precision and clinical excellence.
• Supportive remote work culture with clear adherence to global regulatory standards.