Clinical Study Team Associate II – FSP
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Job Description
Clinical Study Team Associate supporting Parexel’s global clinical trials across Argentina, Brazil, and Mexico. Managing study operations, documentation, systems, timelines, and compliance.
Responsibilities:
- Provide study-level operational support from study start-up through close-out and submission
- Maintain and oversee study team shared spaces, Trial Master Files, Study Team on Demand, client registries, and required systems
- Analyze, interpret, and follow up on study metrics
- Track and oversee study information and follow up with functional lines
- Coordinate study-level forms and data entry into clinical operations applications and systems
- Provide study-level reporting supporting clinical trial data, budgets, and timelines
- Perform quality control of essential clinical trial documentation, including Clinical Study Report components and regulatory submissions
- Support Independent Oversight Committees, audit and inspection readiness, and clinical trial budget tracking
- Provide logistical and operational support for Investigator Meetings
- Coordinate document translations as required
- Provide task status updates and contribute to study team meetings
- Support system setup and maintenance and global study team communications to sites
- Coordinate and prioritize multiple study tasks with minimal oversight
- Partner with Clinical Study Team Leads, Global Study Managers, and Study Managers on operational leadership, site management, monitoring, and vendor oversight
- Support onboarding training, train and mentor new hires and entry-level CSTAs, and serve as a subject matter expert on CSTA processes, systems, and tasks
- Identify continuous improvement opportunities and comply with required training, timesheets, expense reports, and CV updates
Requirements:
- Bachelor’s of Art or Bachelor’s of Science with minimum of 3 years experience, or Master’s of Art, Master’s of Business Administration or Master’s of Science with minimum of 1 year experience
- Proficient in Microsoft Office applications (Outlook, Word, PowerPoint, Excel, Teams)
- Effective verbal and written communication skills
- Fluency in written and spoken English required
- Ability to work independently and as part of a larger team
- Ability to multitask and manage multiple competing priorities
- Self-motivated and able to organize tasks to meet timelines and deliver high-quality work
- Attention to detail and disciplined approach to document review, SOP adherence, and metrics
- Good problem-solving and decision-making skills
- Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research preferred
- Science background preferred
- Experience with clinical trial processes and applicable systems preferred
- Knowledge of the drug development process preferred
Benefits:
- No benefits, perks, or compensation extras are specified in the posting
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