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Regulatory Affairs Associate

3 months ago

Grand Rapids, United States START Center for Cancer Research Full time
Job DescriptionJob DescriptionThe 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 Regulatory Affairs Associate at our START Midwest location in Grand Rapids, MI. This role will prepare and submit study documents to the IRB for assigned studies. This includes, but is not limited to, revised protocols, revised investigator’s brochures, protocol clarification letters/memos, revised informed consents (ICs), new ICs, continuing review reports, closure reports, serious adverse events, IND safety reports, unanticipated problems, protocol deviations, and waivers.

Essential Responsibilities
  • Serve as the main point of contact with the IRB regarding those studies. Enter all submission dates in FileMaker database, note pending information and generate status reports as required. Respond to inquiries and follow up, as required, on pending items.
  • Maintain Investigator Site File (ISF) (paper and/or electronic). This includes, but is not limited to, IRB submissions, IRB approvals, study documents, and study correspondence.
  • Process serious adverse events (SAEs) as assigned.
  • Prepare and manage Close-out Visits for assigned studies.
  • Complete and obtain signatures on essential documents (Form FDA 1572s, Protocols, Amendments, Investigator’s Brochures, and Financial Disclosure Forms, etc.) from appropriate personnel for assigned studies and send initial regulatory packet to Sponsor/CRO (signed signature pages, signed 1572, CVs, licenses, laboratory certifications, normal ranges, etc.) for assigned studies.
  • Attend Site Initiation Visit meetings for assigned studies. Follow-up with the appropriate department(s) and/or the Sponsor/CRO to address any regulatory issues raised during these meetings.

Education & Experience
  • Bachelor’s degree, preferred
  • Three to five years’ experience in a regulatory research setting, preferred
  • Proficient working knowledge of Microsoft Word.
  • Must possess strong organizational skills and a sense of timeliness in completing projects, be detail-oriented, and have good spelling, composition and proofreading skills.

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.