Associate Study Start-Up Specialist

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Study Start-Up Specialist based in Brazil.

This role offers the opportunity to support the successful delivery of clinical studies by managing essential start-up activities and ensuring operational excellence. The professional will work closely with clinical teams, research sites, regulatory bodies, and internal stakeholders to accelerate study activation. You will contribute to improving the efficiency of clinical trial processes while maintaining compliance with quality standards and regulations. The position combines project coordination, regulatory documentation, site relationship management, and process improvement. This is an opportunity to grow within a global clinical research environment focused on advancing healthcare solutions. The ideal candidate is organized, detail-oriented, collaborative, and motivated by making an impact in clinical development.

Accountabilities:: The Associate Study Start-Up Specialist will support study activation processes by coordinating documentation, regulatory submissions, and site activities. The role requires strong organization, attention to detail, and the ability to collaborate across teams to ensure clinical studies progress efficiently and according to established timelines.

Support study start-up activities, initial submissions, and ongoing regulatory processes while ensuring compliance with ICH/GCP guidelines, local regulations, and internal procedures.

Assist with site feasibility activities by evaluating site information and supporting recommendations for site selection and activation strategies.

Coordinate site start-up processes, driving completion of required tasks from site selection through activation.

Prepare and manage submission dossiers for Ethics Committees and Regulatory Authorities according to applicable requirements.

Support informed consent documentation (ICF) preparation, review, submission, and tracking activities.

Manage essential study documents, ensuring accuracy, completeness, and timely availability.

Maintain study start-up information in clinical trial management systems (CTMS), when applicable.

Support regulatory activities after approvals, including submission of required documents and reports.

Contribute to the development of workflows and process improvements that increase efficiency across study start-up operations.

Perform document translation activities for ethical and regulatory materials when required.

Collaborate with clinical operations teams, research sites, and internal stakeholders to achieve project milestones.

Requirements:

The ideal candidate has experience or exposure to clinical research operations, regulatory processes, and study start-up activities. The role requires strong communication skills, organization, and the ability to manage multiple priorities in a highly regulated environment.

Bachelor’s degree or higher in a scientific, healthcare, or related field preferred.

Minimum of 1 year of progressive experience in clinical research, clinical operations, biotechnology, pharmaceutical, CRO, or clinical site environments.

Knowledge of clinical trial execution processes and understanding of ICH/GCP guidelines.

Familiarity with local regulatory requirements and clinical research documentation.

Experience supporting site start-up, regulatory submissions, or essential document management is preferred.

Strong written and verbal communication skills in English.

Highly organized with strong attention to detail and follow-through.

Ability to prioritize tasks and manage deadlines effectively.

Analytical thinking and problem-solving skills.

Proactive mindset with willingness to learn and adapt.

Intermediate proficiency with Microsoft Office tools, including Outlook, Word, Excel, PowerPoint, and Teams.

Availability for occasional travel (up to 10%).

Benefits:

Full-time employment opportunity.

Hybrid work model based in São Paulo.

Opportunity to work in a global clinical research environment.

Exposure to innovative healthcare and clinical development projects.

Professional growth opportunities through collaboration with experienced international teams.

Inclusive and collaborative workplace culture.

Opportunities to develop expertise in clinical operations and study start-up processes.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1