Clinical Study Team Associate II – FSP

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

📋 Description

• Deliver operational support at the study level from initiation to completion and submission.

• Manage and oversee shared spaces for the study team, Trial Master Files, Study Team on Demand, client registries, and necessary systems.

• Evaluate, interpret, and follow up on study metrics.

• Monitor and manage study information, ensuring to follow up with functional lines.

• Organize study-level forms and enter data into clinical operations applications and systems.

• Generate study-level reports that assist with clinical trial data, budgets, and timelines.

• Conduct quality control on essential clinical trial documents, including components of Clinical Study Reports and regulatory submissions.

• Assist Independent Oversight Committees and ensure audit and inspection readiness, along with tracking clinical trial budgets.

• Offer logistical and operational assistance for Investigator Meetings.

• Coordinate document translations as necessary.

• Provide updates on task statuses and participate in study team meetings.

• Support system setup and maintenance, as well as global study team communications with sites.

• Organize and prioritize various study tasks with minimal supervision.

• Collaborate with Clinical Study Team Leads, Global Study Managers, and Study Managers on operational leadership, site management, monitoring, and vendor oversight.

• Facilitate onboarding training, mentor new hires and entry-level CSTAs, and act as a subject matter expert on CSTA processes, systems, and tasks.

• Identify opportunities for continuous improvement and ensure compliance with necessary training, timesheets, expense reports, and CV updates.

⛳️ Requirements

• Bachelor's degree in Arts or Sciences with at least 3 years of experience, or a Master's degree in Arts, Business Administration, or Sciences with a minimum of 1 year of experience.

• Skilled in Microsoft Office applications (Outlook, Word, PowerPoint, Excel, Teams).

• Strong verbal and written communication abilities.

• Proficiency in written and spoken English is essential.

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

• Ability to juggle multiple tasks and manage competing priorities effectively.

• Self-driven, with the capacity to organize tasks to meet deadlines while delivering high-quality work.

• Meticulous attention to detail and a disciplined approach to document review, SOP compliance, and metrics.

• Strong problem-solving and decision-making capabilities.

• Relevant experience in clinical research or clinical trials, or coursework related to drug development or clinical research is preferred.

• A scientific background is preferred.

• Familiarity with clinical trial processes and relevant systems is preferred.

• Understanding of the drug development process is preferred.

🏝️ Benefits

• No benefits, perks, or additional compensation details are mentioned in the posting.