Clinical Study Team Assistant II – FSP
Posted 3ds ago
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Job Description
Clinical Study Team Assistant supporting Parexel’s LATAM clinical trials from study start-up through close-out. Managing trial systems, documentation, metrics, budgets, timelines, and team coordination remotely.
Responsibilities:
- Provide study-level operational support to the Core Study Team from study start-up through close-out and submission
- Manage and oversee Study Team shared spaces, TMF maintenance and compliance, Study Management Platform, registries, and Clinical Trial Management systems
- Analyze, interpret, and follow up on study metrics
- Track study-level information and coordinate with cross-functional study team members
- Initiate and coordinate study-level forms and data entry across clinical operations applications and systems
- Provide reporting on clinical trial data, budgets, and timelines
- Perform quality control of essential clinical trial, CSR, and regulatory submission documentation
- Manage engagement of Independent Oversight Committees
- Support inspection readiness activities and oversight of Clinical Trial Budget spend
- Provide logistical and operational support for Investigator Meetings
- Provide status updates to the CSTL and actively contribute to Core Study Team meetings
- Coordinate and prioritize multiple study tasks while meeting timelines and quality standards
- Serve as a Subject Matter Expert or Technical Resource for clinical trial processes, systems, and tasks
- Support short-term Clinical Operations special projects
- Support CSTA Managers with onboarding training; train and mentor new hires and junior CSTAs
- Identify continuous improvement opportunities with CSTA Managers
- Manage conflicting priorities and own time to meet targets, timelines, work plans, and deliverables
- Complete assigned client and EP training and adhere to EP and Client SOPs and processes
Requirements:
- Bachelor’s of Science degree or equivalent and 3 years’ experience within the CRO/Pharmaceutical industry
- Proficient in Microsoft Office applications (Outlook, Word, PowerPoint, Excel)
- Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research
- Proficiency in written and spoken English
- Compliance with ICH-GCP, SOPs, and regulatory regulations
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