Regulatory Operations Assistant

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