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Regulatory Affairs Assistant I

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 global phase I oncology clinical trial research site network. Over its 17-year history, START has provided hope to cancer patients in community practices and hospitals by offering access to cutting edge early phase oncology 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 tested at START facilities 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 is needed more now than ever before. There are nearly 20 million new cases of cancer per year across the globe, and 50% of all new clinical trials occur in cancer. Yet, AMCs are saturated with too many trials, too few patients, and not enough capacity to meet the demand. As a result, many of the trials in AMC settings take too long and do not reach patients in need. START offers hope to patients, while allowing clinical researchers to conduct essential trials and biopharma companies the ability to run trials on medicines. START’s legacy is rooted in scientific innovation. As an example, in San Antonio, where START was founded in 2007, START treated the first patient ever with Keytruda – the most effective cancer drug in medical history.

We are hiring a Regulatory Affairs Assistant I.

Essential Responsibilities:
  • Stamp and distribute all incoming departmental mail.
  • Prepare file folders for new studies, if applicable.
  • Maintain Investigator Site Files (ISF) (paper and/or electronic). This includes, but is not limited to, IRB submissions, IRB approvals, study documents, and study correspondence.
  • Complete and obtain study staff signatures, if applicable, on Delegation of Authority Logs (or similar logs) from delegated study staff and update study staff in electronic Investigator Site File (eISF) and FileMaker databases. This includes log review and finalization at study close-out.
  • Obtain Investigator signatures on Protocols, Amendments, Investigator’s Brochures, or other required study-specific documents as needed and send out to appropriate Sponsor/CRO point of contact.
  • Retrieve or receive, review, process and/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, and being available to assist the monitor.
  • Review, route for signature (if needed), and file incoming monitor letters in ISF.
  • File protocol-specific training documentation in ISF.
  • Prepare ISF for archiving.
  • Perform other duties as assigned.

Required Knowledge, Skills & Abilities:
  • High school diploma or equivalent.
  • At least two years’ experience in administrative setting.
  • 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. Able to complete tasks with minimal supervision, understand instructions, compose reports and correspondence. ​​​​​​
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