Clinical Study Team Assistant II – FSP

This is a fully remote position, open to applicants in Mexico, +3 more countries.

📋 Description

• Offer operational support at the study level to the Core Study Team from the initiation phase through to close-out and submission.

• Oversee and manage shared spaces for the Study Team, including TMF maintenance and compliance, Study Management Platform, registries, and Clinical Trial Management systems.

• Evaluate, interpret, and monitor study metrics.

• Track information at the study level and coordinate with members of the cross-functional study team.

• Initiate and coordinate the entry of study-level forms and data across clinical operations applications and systems.

• Generate reports on clinical trial data, budgets, and timelines.

• Conduct quality control checks on essential clinical trial, CSR, and regulatory submission documentation.

• Manage the involvement of Independent Oversight Committees.

• Assist with inspection readiness activities and oversee Clinical Trial Budget expenditures.

• Provide logistical and operational support for Investigator Meetings.

• Deliver status updates to the CSTL and actively participate in Core Study Team meetings.

• Coordinate and prioritize multiple study tasks while adhering to timelines and quality standards.

• Act as a Subject Matter Expert or Technical Resource for clinical trial processes, systems, and tasks.

• Assist with short-term special projects within Clinical Operations.

• Support CSTA Managers in training onboarding; mentor and train new hires and junior CSTAs.

• Identify opportunities for continuous improvement in collaboration with CSTA Managers.

• Manage competing priorities and take ownership of time to achieve targets, timelines, work plans, and deliverables.

• Complete required client and EP training and comply with EP and Client SOPs and processes.

⛳️ Requirements

• Bachelor’s of Science degree or equivalent, along with 3 years of experience in the CRO/Pharmaceutical industry.

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

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

• Strong proficiency in both written and spoken English.

• Adherence to ICH-GCP, SOPs, and regulatory guidelines.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and training.

• Flexible working arrangements.

• Competitive salary and performance-based bonuses.