Regulatory Affairs Assistant

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering access to cutting edge trials throughout the US and Europe. Today, with over 1,300 studies completed, and with research facilities in the United States and in Spain, Portugal, and Ireland, START’s mission is to accelerate the development of new anticancer drugs that will improve the quality of life and survival for patients with cancer and lead to its eventual cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic Medical Centers (AMCs) conduct 80% of cancer trials, such trials reach only 20% of the patient population – leaving the majority of patients who are treated in community practices and hospitals without access to a clinical trial when their care journey calls for one. START serves the many – by bringing cancer trials to physicians and their patients in community hospitals and practices when hope is needed most.

START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. As an example, in San Antonio, where START was founded, START treated the first patient ever with Keytruda – the most effective cancer drug in medical history.

We are hiring a motivated Regulatory Affairs Assistant who will maintain the Investigator Site File (ISF) for assigned investigational drug studies and corresponding documents.

Essential 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 noting 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.
  
  

Education & Experience

• 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.
  
  

Physical And Travel Requirements

• Sitting for extended periods of time.
• Typing and computer use for extended periods of time.
  
  

Best-in-Class Benefits And Perks

We value our employees’ time and efforts. Our commitment to your success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including:

• Comprehensive health coverage: Medical, dental, and vision insurance provided
• Robust retirement planning: 401(k) plan available with employer matching
• Financial security: Life and disability insurance for added protection
• Flexible financial options: Health savings and flexible spending accounts offered
• Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided
• Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture.
  
  

More About The START Center For Cancer Research

Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 43 therapies that were approved by the FDA. START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. Learn more at STARTresearch.com.

Ready to be part of a team changing 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 us bring hope and healing to patients worldwide. Please submit your application online.

We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.