Site Activation Partner I

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Accountable for leading or assisting in operational activities from initiation to completion for designated studies and investigator sites, ensuring adherence to study timelines and compliance with applicable regulations, Good Clinical Practices, and Client standards.

• Initiate and coordinate essential activities and document management during the start-up phase, contributing to the preparation of a comprehensive Investigator Initiation Package (IIP) for site initiation approval.

• Register investigator sites and Client stakeholders in Client registries and systems as necessary.

• Directly engage with investigator sites to verify readiness for site start-up.

• Prepare, validate, and submit regulatory documents for internal regulatory approval within the stipulated timelines.

• Ensure the upkeep of IRB/Ethics and other committee activities as applicable.

• Assist in compiling the Central Investigator Review Board (IRB) package and submissions for study approval.

• Collaborate with the Study Team on the development and preparedness of the electronic Investigator Site File (eISF) for sites.

• Maintain regular communication with the study team and respond promptly to inquiries from both the study team and investigator sites.

⛳️ Requirements

• At least 3 years of relevant experience in clinical site management, particularly within the US and Canada.

• Preferred experience in the pharmaceutical industry or a Contract Research Organization (CRO) focused on study site activation.

• Familiarity with clinical trial methodologies, ICH/GCP guidelines, FDA regulations, and both global and local country regulations.

• Strong verbal and written communication skills for effective interaction with colleagues and associates both internally and externally.

• Proficient technical skills and the ability to learn and navigate multiple systems.

• Proven understanding of clinical research and development processes, key operational elements of a clinical trial, and capacity to grasp process intricacies.

• Detail-oriented with a disciplined approach to work.

• Capable of working independently as well as collaboratively within a team.

• Strong organizational skills, with the ability to manage tasks, time, and priorities, while multitasking effectively.

• Knowledge of basic medical terminology, GCP requirements, and proficiency in computer operations.

• Fluency in the local language and English is required; proficiency in additional languages is a plus.

🏝️ Benefits

• Flexible work arrangements

• Professional development