Site Activation Partner I – FSP, Fixed-Term, 7 months

This is a fully remote position, open to applicants in Brazil, +2 more countries.

📋 Description

• Lead or assist in operational tasks from the initiation to the closure of assigned studies and investigator sites.

• Initiate, coordinate, and manage essential documentation activities during the start-up phase through the compilation of the Investigator Initiation Package (IIP) and site initiation approval.

• Register investigator sites and client stakeholders within client registries and systems, ensuring the maintenance of accurate, inspection-ready records.

• Communicate with investigator sites to verify readiness for site start-up and review or complete site profiles and critical information.

• Address and escalate site-related issues promptly.

• Prepare, validate, and submit regulatory documents for internal approval.

• Coordinate supporting roles and activities to ensure timely activation of sites.

• Assist with Central and local IRB/Ethics Committee packages, submissions, approvals, workflows, communications, and responses.

• Aid in managing non-clinical trial supplies and tracking information.

• Collaborate on electronic Investigator Site File readiness and oversee site and monitor access prior to the Site Initiation Visit.

• Prepare, manage, distribute, file, and archive clinical documentation and reports.

• Support and implement activities within the Shared Investigator Platform.

• Coordinate in-scope document translation with preferred vendors.

• Manage essential documents and study updates throughout the study lifecycle, including protocol amendments and Ethics Committee approvals.

• Maintain IRB/Ethics Committee activities and file documents in the Trial Master File.

• Update clinical trial systems to track site compliance and performance.

• Provide support to investigator sites and study teams during audits and inspections.

• Maintain open communication with study teams and investigator sites, providing updates at both country and site levels.

• Create tools for tracking study status, issues, delays, and approval updates.

• Disseminate Central and Local Ethics approvals to pertinent stakeholders.

• Conduct awareness sessions for site personnel as necessary.

• Identify and address issues at investigator sites, supporting corrective and preventive actions.

• Complete assigned training and adhere to EP and Client SOPs and processes.

• Potentially support activities across multiple countries.

• Act as the study Point of Contact, Subject Matter Expert, global initiative representative, or mentor as assigned.

⛳️ Requirements

• A minimum of 3 years of relevant experience in clinical site management, specifically within the US/Canada.

• At least 2 years of experience in start-up processes related to US/Canada operations.

• High school diploma/certificate with an equivalent combination of education, training, and experience.

• Bachelor of Science, Bachelor of Arts, or Bachelor’s degree in Life Sciences is preferred.

• Experience in the pharmaceutical industry or a CRO, particularly in study site activation, is preferred.

• Comprehensive knowledge of clinical trial methodologies, ICH/GCP, FDA regulations, and global and local country regulations.

• Strong verbal and written communication skills.

• Good technical acumen and the capacity to learn and operate various systems.

• Knowledge of clinical research and development processes, along with key operational components of a clinical trial.

• Ability to comprehend process details and comply with company, regulatory, and country requirements.

• Keen attention to detail and a methodical approach.

• Capability to work independently as well as collaboratively within a team.

• Proficiency in organizing tasks, managing time and priorities, and multitasking effectively.

• Understanding of basic medical terminology and GCP requirements.

• Proficient in computer operations.

• Required fluency in both the local language and English; multilingual capabilities are preferred.

• Ability to utilize and learn Microsoft Suite, Clinical Trial Management Systems (CTMS), Electronic Trial Master File, Electronic Investigator Site File, document exchange portals, Shared Investigator Platform, and ethics, national networks, and governing bodies portals/platforms.

🏝️ Benefits

• Opportunity to transition into a full-time role.

• Client- and/or EP-assigned training, including general training, SOP, system, and process-related training.

• Professional mentoring opportunities for new employees.