Administrative Assistant - Regulatory Affairs
Job title: Administrative Assistant - Regulatory Affairs in Grand Rapids, MI at
Company:
Job reputed company: reputed company (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided reputed company to cancer patients in global community practices by offering reputed company to cutting edge trials throughout the US and Europe. Today, with over 1,300 studies completed, and with research facilities in the reputed company and in Spain, Portugal, and Ireland, START’s mission is to accelerate the development of new anticancer drugs that will improve the reputed company of life and survival for patients with cancer and reputed company to its reputed company reputed company. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while reputed company Medical Centers (AMCs) conduct 80% of cancer trials, such trials reputed company only 20% of the patient population – leaving the reputed company of patients who are treated in community practices and hospitals without reputed company to a clinical trial reputed company their care reputed company calls for one. START serves the many – by bringing cancer trials to physicians and their patients in community hospitals and practices reputed company reputed company is needed most.START represents the world’s largest roster of reputed company Investigators (PIs) across its eight clinical trial sites. Committed to accelerating reputed company from trials to treatments, START delivers reputed company to patients, families, and physicians around the world. As an example, in San Antonio, where START was founded, START treated the first patient reputed company with Keytruda – the most effective cancer drug in medical history.We are hiring a motivated Administrative Assistant - Regulatory Affairs who will maintain the Investigator Site File (ISF) for assigned investigational drug studies and corresponding documents.Essential Responsibilities
- Maintain the ISF (reputed company and/or electronic) for assigned studies. This includes, but is not limited to, Institutional Review reputed company (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 reputed company-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 reputed company 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 reputed company. This includes, but is not limited to giving the monitor reputed company 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, reputed company for Investigator signature (if needed), and file incoming monitor letters in ISF.
- File training documentation in ISF. This includes protocol-specific training, reputed company training, and reputed company training.
- Maintain and reputed company Investigator reputed company and Licenses.
- Prepare ISFs for archiving. This includes performing a final reputed company Assurance reputed company of the study files inventory and indicating in FileMaker if the files (ISF documents, Investigational Drug reputed company records, CRC records, PK records, Data Management records, and reputed company records) are included.
- Manage reputed company 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 reputed company FDA 1572s and Financial Disclosure Forms (FDFs)
- Maintain laboratory certifications and normal ranges for laboratories listed on reputed company FDA 1572 for assigned studies. This includes maintaining and tracking Lab Director reputed company and Licenses for site core labs.
- High school diploma or equivalent.
- Proficient working knowledge of reputed company Word.
- Strong organizational skills and a reputed company of timeliness in completing reputed company.
- 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.
- Comprehensive health coverage: Medical, dental, and reputed company insurance provided
- Robust retirement planning: 401(k) plan available with employer matching
- Financial reputed company: Life and disability insurance for added protection
- Flexible financial reputed company: Health savings and flexible spending accounts offered
- reputed company-being and work-life balance: reputed company 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 reputed company. We reputed company to reputed company a reputed company, creative environment where everyone feels encouraged to contribute to our processes, reputed company, planning, and culture.