REGULATORY & STUDY START-UP ANALYST I
Colombia OR Argentina
Remote

Who We Are

Intrials is a disruptive company with all the attributes that a CRO must master. We mix innovative projects with the necessary skills to provide a full service. Nothing stops us in the search for knowledge. Transforming people's lives through science when it comes to solving the challenges of our clients' projects in a focused and exclusive fashion.

Diversity & Inclusion are essential to continue building our history of innovation. Diversity of color, belief, sexual orientation, religion, or any other characteristic are very welcome in all open positions at our company. It is a fundamental part of Intrials to constantly think and implement actions that reinforce the importance of good coexistence with all the people who are part of our DNA and together, to leverage and build true impactful results in our society.

Basic Functions and Responsibilities includes, but are not limited to:

Responsible for the activities related with:
▪ Regulatory Affairs for Clinical Trials: Local Ethics Committees (LEC)s,



Central Ethics Committees (CEC)s, Minister of Health (MoH) and any Additional Review Bodies (ARB)s;
▪ Study supplies (Investigational Product (IP) and Clinical Trials Material): Importation, Storage, Shipment, Return and Destruction;
▪ Safety Reports Submission to MoH, if applicable;
▪ Compliance with applicable SOPs, Work Instructions, local and international regulations, and Good Clinical Practices (ICH-GCP);
▪ Represent the company as a legal representative before the regulatory bodies, if required;
▪ Work closely with Project Manager (PM) to define regulatory / importation strategies for the assigned studies, as well as, to review, track and follow up the progress, the approval and execution of documents, including ethics, regulatory and essential documents for the regulatory / logistic area, ensuring successful site activation and delivery study milestones.

Primary Activities include

📌 REG & STUDY START-UP ANALYST I Colombia OR Argentina Remote (Bogotá)
🏢 Intrials Clinical Research
📍 Bogotá