Clinical Trial Associate
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OverviewIn this role you support study teams by organizing and maintaining the Study Master File (SMF) and coordinating practical study tasks in line with company policies, SOPs, and regulatory requirements.
You will work within the Functional Solutions team, dedicated to a sponsor, and help ensure GCP compliance and smooth study operations.
You'll interact across the study team, contribute to audits and regulatory inspections, and support documents, meetings, and reporting.
This is a hands-on, cross-functional role with meaningful impact on trial quality and timelines.
Compensaciones / Beneficiosopportunities for personal and professional growth
collaborative environment
values-driven culture (Trust, Quality, Passion, Flexibility, Sustainability)
making a difference in patients' lives
ResponsabilidadesInitiate, maintain and archiving of the SMF with GCP compliance
Set up and maintain study information in CTMS per delegation
Maintain electronic files and prepare Investigator's File per CRA directions
Serve as SMF point of contact and support Lead CRA/PM
Coordinate study supplies and assist with trial-related documents/tools/templates
Assist in status reporting and meeting logistics; take and distribute minutes
Support audits and regulatory inspections activities
SMF completion and shipment preparation to sponsor; collect appendices for final study report
Contribute to study team meetings and organizational routines to improve processes
Support regulatory submissions (IEC/IRBs/CA) and contract management with sites
Assist with document translations; support CRA/PM with remote monitoring activities
Requisitos principalesBachelor's Degree preferred
Knowledge of GCP/ICH guidelines
Good written and communication skills
Good organizational and software/computer skills
Ability to work in a fast-paced environment with changing priorities
Strong communication
Organizational diligence
Team collaboration
CTMS setup and maintenance
SMF management
Electronic file maintenance
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