Regulatory Documentation Specialist – Clinical Trials (Hybrid)

START Center for Cancer Research; Lisboa; Híbrido; 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 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.