Regulatory Operations Assistant

Description

Job Summary: As Regulatory Operations Assistant, you will manage study documentation, support regulatory processes, and ensure compliance for clinical oncology trials. Key Responsibilities: 1. Maintain and update the Investigator Site File (ISF) 2. Manage monitoring visits and regulatory documentation 3. Collaborate on ISF audits and inspections START Center for Cancer Research ("START") is the world's largest network of Phase I centers, exclusively dedicated to clinical oncology research. Throughout our history, START has provided hope to cancer patients in communities worldwide by offering access to cutting-edge clinical trials in the United States and Europe. Today, with more than 1,300 studies conducted and research centers in the United States, Spain, Portugal, and Ireland, START's mission is to accelerate the development of new cancer therapies that improve quality of life and survival for cancer patients—and ultimately lead to their cure. To date, more than 43 therapies conducted at START centers have received FDA/EMA approval. Position Available: **Regulatory Operations Assistant** **Responsibilities:** * Maintain the *Investigator Site File* (ISF) in paper and/or electronic format for assigned studies, including submissions and approvals from Ethics Committees, study documents, and correspondence. * Create and update Delegation of Authority logs and other related systems, including their review and closure upon study completion. * Obtain required signatures from the Investigator on protocols, amendments, investigator brochures, logs, or other study documents, and submit them to the relevant sponsor/CRO. * Receive and file safety reports (IND, SUSAR, and other interim reports) in the ISF. * Manage monitoring visits related to regulatory operations: provide ISF access, resolve queries, and record monitor changes in systems. * Receive, manage for signature (if applicable), and file monitor letters. * Archive training documentation (protocol, EDC, GCP). * Maintain and update CVs and licenses of the Investigator and applicable team members. * Prepare ISF for archiving by performing a final quality control check and recording in systems which documents are included. * Collect and archive IATA certificates for study personnel. * Complete and obtain Investigator signatures on Form 1572 or equivalent forms and Financial Disclosure Forms. * Manage revised versions of study documents (amendments, protocol letters, investigator brochures) for submission to Ethics Committees, updating regulatory files and corresponding systems (including CTMS). * Maintain laboratory certifications, normal ranges, and CVs/licenses of Laboratory Directors. * Archive equipment calibration documentation. * Assist in ISF review for audits and inspections. * Collaborate with the team to meet departmental metrics. * Grant eISF access to new staff. * Perform other assigned tasks. **Requirements:** * Interest in the healthcare field * Prior experience in clinical trials is preferred * Proactive individual with strong organizational skills * Excellent sense of responsibility and attention to detail * Ability to work collaboratively and maintain effective communication with colleagues and supervisors * Intermediate level of English **Benefits** * Monday to Friday working schedule * 28 working days of vacation * Flexible compensation * Opportunity to attend fully free English language classes **Are you ready to join a team that will transform the future of cancer treatment?** Join us in our mission to conquer cancer—one clinical trial at a time. Your expertise and dedication can help bring hope and healing to patients around the world. Submit your application online.