Global Study Associate – FSP

This is a fully remote position, open to applicants in Spain, +4 more countries.

📋 Description

• Provide support for Phase 1, 2, 3, and 4 clinical studies with expert guidance.

• Assist in study and site feasibility, initiation, ongoing maintenance, and closure activities.

• Oversee the review, collection, and tracking of essential documents for studies and sites.

• Aid in the preparation and upkeep of study documents and manuals.

• Supervise the Trial Master File (TMF) to ensure its accuracy and completeness.

• Confirm that study documents are received, assessed, and organized in line with SOPs, GCP, and relevant regulations.

• Coordinate study-related meetings, draft agendas, document minutes, and maintain logs for risks, issues, and decisions.

• Lead and present at study meetings as necessary.

• Conduct site monitoring and co-monitoring visits as required.

• Address findings from internal and site quality assurance audits.

• Manage, coordinate, and supervise the activities of third-party vendors.

• Track and maintain study progress, including status updates, enrollment, site inquiries, deviations, and study-level documents and plans.

• Participate in clinical trial team meetings and collaborate on protocol development and CRO selection.

• Support oversight of study sites, focusing on performance metrics and monitoring report evaluations.

• Assist in study data management activities, including reviewing data, creating and resolving queries, and conducting deviation and safety reviews.

• Collaborate across functions and provide oversight for CRO and vendor operations.

• Review and validate contracted vendor activities, including vendor invoice assessments.

• Facilitate study reporting and tracking with the use of relevant systems and technology.

• Assist study leads in achieving cross-functional alignment on study timelines.

• Complete necessary training, timesheets, expense reports, and CV updates.

• Stay informed about and comply with Parexel processes, ICH-GCPs, and other relevant requirements.

⛳️ Requirements

• A bachelor's degree (BA or BS), a nursing degree, or an equivalent qualification.

• Minimum of 3 years of experience in clinical studies as a SCRA or Lead CRA.

• Proficient understanding of Good Clinical Practice (GCP) regulations and Standard Operating Procedures.

• Comprehension of study phases and their relevance in clinical development.

• Familiarity with electronic systems, including the Trial Master File and CTMS (e.g., Veeva Vault, Smartsheet, SharePoint).

• Knowledge of computer application principles in database management.

• Willingness to travel 10% to 20% may be necessary.

• Strong verbal and written communication capabilities.

• Ability to work autonomously and collaboratively within a team.

• Advanced skills in Microsoft Word, Excel, and PowerPoint.

• Capability to prioritize and manage multiple responsibilities simultaneously.

🏝️ Benefits

• Competitive salary.

• Comprehensive benefits package.

• Medical care plan: Health, Dental & Vision.

• Life Assurance coverage.

• Exceptional work environment.

• A culture that fosters teamwork and collaboration.

• Motivating colleagues who tackle challenges together.

• Access to innovative technology.

• High-quality training opportunities.

• Paid time off.

• Life insurance benefits.

• Health insurance coverage.

• Additional benefit offerings based on applicable plans.

• Potential for additional incentives, bonuses, or other compensation programs for eligible positions.