The START Center for Cancer Research

Regulatory Operations Assistant

The START Center for Cancer Research  •  Lisbon, PT (Remote)  •  4 hours ago
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Job Description

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.

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
The START Center for Cancer Research

About The START Center for Cancer Research

Deeply rooted in community oncology centers globally, the START Center for Cancer Research ("START") provides patients with access to specialized Phase 1 clinical trials for novel anti-cancer agents. With research sites in the United States and in Spain, Portugal, and Ireland, START’s clinical trial sites have conducted more than 1,500 early phase clinical trials, including for 45 therapies that have gained FDA/EMA approval. Founded in Texas in 2007, START today boasts 30+ Principal Investigators (PIs) across its worldwide clinical trial sites. With over 100,000+ square feet of world-class research facilities, START offers patients comprehensive treatment plans that include multi-specialty services, genetic profiling of tumors, targeted therapies, state-of-the-art treatment technology, and advanced access to clinical research options. START is committed to accelerating passage from trials to treatments, and to delivering hope to patients, families, and physicians around the world.

Industry
Biotech & Life Sciences
Company Size
201-500 employees
Headquarters
San Antonio, Texas
Year Founded
Unknown
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