Research Blog: Resources as Far as the Eye Can See (A Four-Part Mini-Series)

With more than $100 million in awards across nearly 100 grant proposals in the current fiscal year, there’s never been a better time to be a researcher in the Department of Medicine at the University of Arizona College of Medicine – Tucson.

This truism holds whether you are a fellow considering your first research project or a seasoned and funded investigator, whether you are working with industry funding or seeking funding to test your own hypothesis.

Truly! The resources and services available today have accumulated with great speed these past few years, thanks in large part to the support, leadership, and vision of Department Chair Dr. Monica Kraft, who is a prolific asthma researcher. 

Our office was created by Lauren Zajac, CRA, in 2014 as executive director of Research Administration. With 20 years of experience in research administration at academic medical centers, Lauren set forth in creating a one-stop-shop focused on concierge-level customer service for investigators.

NOTE: Patients interested in learning more about research at the UA Department of Medicine should visit our Research tab above. You can also find out more about Clinical Research Studies at the UA Health Sciences here.

Let’s get down to the basics:

Your Research Administration Office:

Part 1 of 4 – Your Pre-Award Team

Who: We have a team of 10 research administrators dedicated to pre-award support across Health Sciences. This group, by working with investigators such as you, collectively submitted about 40 percent of all of the proposals across the entire UA last year. Your leads as a Department of Medicine faculty member are the excellent and knowledgeable:

  • Karen Grinfeld, MA, Senior Research Administrator, who herself worked in the Department of Medicine for seven years as a grant coordinator prior to our centralization, and
  • Angela Valencia, MPH, Research Administrator, who worked in the UA Cancer Center and other UAHS colleges as a research coordinator and is a certified medical translator.

What: This dynamic duo helps you in finding funding opportunities, reviewing the sponsor guidelines and restrictions, crafting a project management plan and timeline for on-time submissions, drafts your budget and budget justification, coordinates the collection and review of letters of support, biosketches, collaborating institution documents, and secures all necessary departmental, college, and university approvals for a quality and compliant submission.

Where: They prefer to come to you, but welcome visitors as well! You can find us on the fourth floor of the Health Sciences Library.

When: Reach out to them as soon as you’ve identified a funding opportunity—even if you’re still refining your aims. The more time they have to partner with you, the more services they can provide.

How: Email preaward@email.arizona.edu to get started.

Why: Better science and more time! When we support the administrative sections of your proposal, it allows you more time—amidst your many competing duties to focus on your science. With a huge increase of over $108 million across 96 proposals during FY16, the Department of Medicine is the definition of success!

Part 2 of 4 – Your Post-Award Team

Who: Providing support for post-award needs outside the day-to-day transactions that are essential to remain in-house by your business and division managers are:

What: Progress Report review and guidance on sponsor requirements, management plan guidance for unobligated balances, support for any changes requiring prior approval from sponsors, sub-award paperwork, and departing PI transitions.

Where: Most of our support can be done virtually over email and phone. Meetings are always welcome and can occur in your office or lab space, or on the fourth floor of the Health Sciences Library in our meeting rooms.

When: As soon as you receive your Notice of Award, we ideally would love to review your award’s terms and conditions with you and your business manager as a best practice. This way we can get future progress report deadlines on the calendar as well as review what kinds of changes might require prior approval, and any sub-award paperwork that needs to be set up.

How: Please email postaward@email.arizona.edu with any questions or to set up a meeting.

Why: When it comes to progress reports, your business office reviews the financials and Sponsored Projects reviews very specific sections prior to submission. However, our office provides an additional level of review for specific sponsor compliance as well as from a project management perspective. We can identify red flags from a Grants Management Specialist perspective and ensure you are putting your best foot forward as PI.

Part 3 of 4 – Your Clinical Trials Team

Who: Our Clinical Trials team works closely with Principal Investigators and Study Coordinators on clinical trials which require involvement of a clinical partner such as Banner Health. This includes utilizing our clinical partner’s patients, services, procedures, or resources.

  • Led by Chris Gaul, MBA, Senior Research Administrator, they have more than 81 years’ experience as a group working on clinical trials, and is regularly invited to present at national conferences in addition to organizing continuing education for coordinators across the Colleges of Medicine and Cancer Center.
  • Annet Mejia, Principal Accountant for Clinical Trials, is an experienced accounting manager who works closely with departmental accounting staff to implement procedures and tracking systems for clinical trial earnings, timely sponsor billing and collection of receivables. She also works closely with Banner Health and Banner Research to streamline the invoice and payment process.

What: From compliance regarding your payer coverage analysis to budget negotiation, contract tracking, billing review, and more, this team supports you closely from start to finish.

Where: You can find them on the fourth floor of the Health Sciences Library, at the monthly Clinical Research Coordinator Meetings, or ask them to meet with you in your area anytime!

When: As soon as you have received a protocol from a study sponsor, reach out to us. Even if you have an existing clinical trial, we can help to review your income and contract to be sure you’re receiving payment for all of your activity.

How: Email crc@medicine.arizona.edu — the team will respond within 24 hours.

Why: Compliance and cost! Banner has approved our process for study start-up and requires groups to work with us to ensure compliance from a risk management perspective for subject research procedures. From your perspective as a PI, we work with sponsors on a daily basis and have a big picture view of your budget from what the sponsor will allow to what you should consider to ensure you have the funds necessary to complete the study.

Part 4 of 4 – Your Regulatory Team

Who: A veritable powerhouse of regulatory support, expertise, and guidance is now available to you as researchers:

  • Danielle Gartner, CIP, is our Senior Research Administrator leading the team. Danielle worked in the UA Human Subjects Protection Program for six years, and she is a certified IRB professional.
  • Elena Young, MS, CCRP, is our Regulatory Coordinator based out of Phoenix supporting study start-up and ongoing regulatory needs. She is a certified clinical research professional with her Master’s degree in clinical research management. She’s also on the Board of Native Health in Phoenix.
  • Kellie Bemelmans, JD, brings a BS in clinical research from UNC-Wilmington and certification in professional writing. She has industry experience with clinical trials as a senior clinical research associate in oncology and infectious disease and working as a site activation specialist for informed consent and essential document review guidelines.

What: From drafting your local IRB protocol and submission, to assistance with site initiation and monitor visits, and everything in between.  This team is here to help shepherd you through the regulatory process- however that process looks for you.

Where: Most of our support can be done virtually over email and phone. Meetings are always welcome and can occur in your office or lab space, or on the fourth floor of the Health Sciences Library in our meeting rooms, or in Phoenix at the COM-P or BUMCP campuses.

When: At any point in the regulatory process you can reach out to our team. We have experience with start start-up, continuing review paperwork, modification submission, monitor preparation, binder assistance, and study close-out. No question is too small!

How: You can email regulatory@email.arizona.edu with any questions or to set up a meeting.

Why: Sometimes it can be difficult to know if you’re making the right decisions as an investigator. There are multiple federal, state, and local requirements that fall on research at the UA. It can be helpful to talk through your ideas with someone who understands the overall compliance needs as well as the logistics of putting research into place. We work closely with the IRB and with study sponsors on a daily basis and can help answer your questions quickly and efficiently!

COMING SOON!!!
Other Research Colleagues:
     » RDS Biomedical & Cancer
          ○ Early Investigator Funding Opps
     » Tech Launch Arizona
     » Health Sciences Library

Meanwhile, learn more about these and other tools and resources to assist you at the UAHS Research Administration website: http://research.uahs.arizona.edu

About The Author

Rachel Peterson is associate director of Research Administration for the University of Arizona Health Sciences. Since her arrival in Arizona a decade ago, she has supported research programs in the UA College of Medicine – Tucson Departments of Pediatrics, Surgery and Psychiatry. Presently, she oversees operations for all UAHS investigators through a "one-stop shop" Research Administration team that supports the management, maximization and compliance of the sponsored research portfolio. Rachele has a bachelor’s degree in Public Policy Analysis with honors from the University of North Carolina at Chapel Hill and a master’s degree in Clinical Research Management summa cum laude from Arizona State University. She also serves as the administrative project director of the UA-Banner Health Precision Medicine Initiative All of Us℠ Research Program.