Clinical Trial Master File & Compliance Associate

TFS HealthScience; Barcelona; On-site; EUR 27,000 - 38,000; Full time

Job summary

TFS HealthScience is seeking a Clinical Trial Associate to organize and maintain the Study Master File (SMF) and coordinate practical tasks throughout the study in line with SOPs and regulatory requirements.

In this role you will work within our Functional Solutions team, supporting one sponsor and contributing to audits, study material preparation, status reporting, and regulatory submissions. Strong GCP knowledge and CTMS experience are valued.

Qualifications

• Bachelor’s degree preferred.
• Knowledge of GCP/ICH guidelines.
• Good written and communication skills.
• Good organizational skills.
• Good software and computer skills.
• Able to work in a fast paced environment with changing priorities.

Responsibilities

• Work with the Study Team in initiating, maintaining and closing/final archiving of the SMF, ensuring GCP compliance.
• Set up and maintenance of study information in CTMS as per delegation from PM/ Lead CRA or CRA.
• Maintenance of electronic files.
• Set up the Investigator’s File as directed by the CRA.
• Point of contact regarding SMF.
• Maintain the SMF as directed by the Lead CRA/Project Manager.
• Coordinate study supplies as directed by the CRA.
• Drafts and/or assists with the preparation of trial-related documents, tools and templates.
• Assist in status reporting.
• Arrange internal and external meetings.
• Actively taking part in Study Team meetings and be responsible for the minutes.
• Prepare, contribute to and distribute presentation material for meetings and newsletter.
• Assist in activities associated with audits and regulatory inspections.
• SMF completion and preparation of shipment to sponsor as directed by the Lead CRA/CRA.
• Collection of appendices for final Clinical Study report.
• Actively contribute to the organization and development of routines to enhance the work at TFS
• Work with the Study Team in all regulatory process (IEC/IRBs/CA ) including submission and amendments, regulatory fees.
• Assist the CRA, PM or Lead CRA managing contracts with sites, including contract status.
• To manage Investigator Payments as directed by PL or Lead CRA.
• Assist the PL with document translations process.
• May support the CRAs with some monitoring remote activities: collection of documentation, follow up on data entry, queries resolution.

Skills

Communication skills

Organizational skills

Adaptability to fast-paced environment

GCP/ICH knowledge

Education

Bachelor’s Degree

Tools

CTMS

Microsoft Office

Job description

TFS HealthScience is seeking a Clinical Trial Associate to organize and maintain the Study Master File (SMF) and coordinate practical tasks throughout the study in line with SOPs and regulatory requirements.

In this role you will work within our Functional Solutions team, supporting one sponsor and contributing to audits, study material preparation, status reporting, and regulatory submissions. Strong GCP knowledge and CTMS experience are valued.