Regulatory Operations Assistant

START Center for Cancer Research; Lisboa; Presencial; EUR 28 000 - 40 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work model

Temporary contract (5-6 months)

40 hours per week

Resumo da oferta

START Center for Cancer Research seeks a detail-oriented records specialist to support a 5-6 month document cleanup project in Lisboa. You will review protocols, update eBinders, and ensure regulatory-compliant documentation across systems.

This role requires strong organizational skills, experience with clinical trial documentation, and the ability to coordinate with study teams to maintain accurate ISFs and training records. Hybrid work arrangement provided.

Qualificações

• Degree in Health Sciences or related field.
• Proficient in English.
• Highly organized with strong document management skills.
• Good communication and teamwork abilities.
• Interest in clinical research and regulatory environment.

Responsabilidades

• Manage and maintain clinical trial documentation.
• Oversee, update, and archive Investigator Site Files (ISFs).
• Coordinate documentation activities for start-ups, maintenance, close-outs, and audits.
• Review and maintain version control of regulatory documents.
• Manage training records and delegation logs; electronic signatures.
• Update information and track tasks in systems such as OnCore.
• Collaborate with research teams, monitors, and other departments to ensure smooth conduct of studies.
• Ensure compliance with Good Clinical Practice (GCP) guidelines and internal procedures.

Descrição da oferta de emprego

START Center for Cancer Research is a leading organization in Phase I oncology clinical research, dedicated to accelerating the development of new cancer therapies. With a presence across the United States and Europe, we have participated in more than 1,300 clinical trials and contributed to the development of over 40 treatments approved by the FDA and EMA.

Position Summary

We are seeking a professional to support a temporary document clean-up and update project. This role will involve reviewing protocols and eBinders, ensuring documentation is properly organized within company systems, correcting inconsistencies across platforms, and maintaining accurate, complete, and regulatory-compliant records. This position requires a strong attention to detail, excellent organizational skills, and experience managing documentation within a clinical research environment.

Key Responsibilities

• Manage and maintain clinical trial documentation.
• Oversee, update, and archive physical and electronic Investigator Site Files (ISFs).
• Coordinate documentation activities for study start-ups, ongoing maintenance, close-outs, and audits.
• Review and maintain version control of regulatory documents.
• Manage training records, delegation logs, and electronic signatures.
• Update information and track tasks in systems such as OnCore.
• Collaborate with research teams, monitors, and other departments to ensure the smooth conduct of clinical studies.
• Ensure compliance with Good Clinical Practice (GCP) guidelines and internal procedures.

Requirements

• Degree in Health Sciences or a related field.
• English proficiency
• Highly organized and detail-oriented profile with strong document management skills.
• Good communication and teamwork abilities.
• Interest in clinical research and the regulatory environment.

Additional Information

• Temporary contract: 5-6 months
• Working hours: 40 hours per week, Monday to Friday
• Hybrid remote work model