Note: The job is a remote job and is open to candidates in USA. The START Center for Cancer Research is an oncology clinical research site network conducting early-phase clinical trials. The Regulatory Operations Assistant will maintain Investigator Site Files and regulatory study documentation, coordinate submissions and signatures, manage training and investigator records, support monitor visits, and prepare files for archiving.
Responsibilities
- Maintain the ISF (paper and/or electronic) for assigned studies. This includes, but is not limited to, Institutional Review Board (IRB) submissions, IRB approvals, study documents, and study correspondence
- Create and update the Delegation of Authority Logs (or similar logs) and systems (i.e., electronic ISF and FileMaker databases) with study staff changes for assigned studies. This includes log review and finalization at study close-out
- Obtain Investigator signatures on Protocols, Amendments, Investigator’s Brochures, Logs, or other required study-specific documents as needed and send out to appropriate Sponsor/CRO point of contact
- Retrieve or receive, review, process or submit IND Safety reports, SUSAR reports, and other interim safety reports to the IRB and file in ISF
- Handle monitor visits. This includes but is not limited to giving the monitor access to the ISF, ensuring the monitor signs the Monitor Visit Log, if applicable, being available to assist the monitor, and notifying monitor changes in FileMaker
- Receive, route for Investigator signature (if needed), and file incoming monitor letters in ISF
- File training documentation in ISF. This includes protocol-specific training, EDC training, and CITI training
- Maintain and track Investigator CVs and Licenses
- Prepare ISFs for archiving. This includes performing a final Quality Assurance check of the study files inventory and indicating in FileMaker if the files (ISF documents, Investigational Drug Section records, CRC records, PK records, Data Management records, and accounting records) are included
- Manage CITI training completion of study staff. This includes sending renewal reminders and following up with staff until completed
- Intake revised study documents (Amendments, Protocol Letters or Notes to File, and Investigator’s Brochures) for IRB submission. This includes, stamping documents, adding documents to the S Drive and/or the ISF, notifying the study team of receipt of documents, logging documents and dates into the FileMaker database, creating a task list in OnCore and updating the task list as required, and maintaining a spreadsheet of documents processed for IRB submission
- Complete and obtain Investigator signatures on updated Form FDA 1572s and Financial Disclosure Forms (FDFs)
- Maintain laboratory certifications and normal ranges for laboratories listed on Form FDA 1572 for assigned studies. This includes maintaining and tracking Lab Director CVs and Licenses for site core labs
Skills
- High school diploma or equivalent
- Proficient working knowledge of Microsoft Word
- Strong organizational skills and a sense of timeliness in completing projects
- Detail-oriented with good spelling, composition and proofreading skills
- Ability to complete tasks with minimal supervision, understand instructions, compose reports and correspondence
- Sitting for extended periods of time
- Typing and computer use for extended periods of time
Benefits
- 401(k) retirement savings plan with employer match
- Eligibility for an annual performance bonus, based on role and company results
- Generous paid time off and paid holidays
- Comprehensive medical, dental, and vision coverage and optional insurance options
- Company paid life and disability insurance for added financial protection
- Employee Assistance Program (EAP) providing confidential, no-cost support for you and your family from day one
- Flexible FSA and HSA plans to support your financial wellness
- Commitment to a supportive environment that values balance, wellbeing, and flexibility
- A collaborative, creative workplace where every team member is encouraged to contribute
- Continuous learning and professional growth
- A culture built on inclusivity and innovation
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