My Specialty

Clinical Research Nurse, Anita Karra, City of Hope

Gathering data and managing patients enrolled in clinical trials

How did your nursing career begin and what types of nursing work have you done?

I began my nursing career in 2009 as a research nurse at the Hemophilia Treatment Center of Western Pennsylvania in Pittsburgh. The medical director, Margaret Ragni, M.D., MPH, took a chance by employing a new graduate nurse in this clinical research position.

Since I had worked as a data assistant at a vaccine research company while I was in nursing school, she felt I had the knowledge base and potential to succeed in the role. I went on to clinical research positions at John Hopkins Division of Pediatric Hematology; Dowling Apheresis Clinic at the NIH Clinical Center; the Murtha Cancer Center at Walter Reed National Military Medical Center; Virginia Cancer Specialists; and then City of Hope.

Where did your interest in research come from?

After I finished nursing school, I wanted to become a clinical research nurse so that I could actively participate in helping patients access novel therapies. I became fascinated with the way clinical trial patient data drives the FDA approval process for pharmaceutical companies. It was very informative to see firsthand how children enrolled in vaccine clinical trials contribute to new therapies coming to market.

The drug development process for FDA approval of a new drug is quite rigorous and important, as it brings drugs to market. Basic science determines whether to move forward from the discovery of an agent to preclinical testing utilizing animals and then to human clinical trials.

Tell us a little about your role.

As a CRN, I manage patients involved in human clinical research. Depending on the outcome of clinical trials, data may be submitted to the FDA for the approval or rejection of new drugs. Clinical research nurses need to be cognizant of the importance of gathering accurate data and ensuring that patients stay in compliance with the clinical trial protocols, which are very data-driven and have tight submission timelines.

Keeping HIPAA in mind, is there a patient story you can share to illustrate this process?

I had a multiple myeloma patient who had been through at least 23 lines of treatment before she enrolled in a CAR-T trial. CAR-T (chimeric antigen receptor T-cell) therapy is an exciting new technique that collects a patient’s own cells and genetically modifies them to kill the patient’s cancer. The patient entered the trial with high hopes of clearing all her disease. However, her clinical trial journey was complicated by aggressive disease and issues with the manufacturing of her specific CAR-T product.

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Our clinical team kept her from being discouraged, and she had the tenacity see her treatment through. Although she did not respond as well as she had hoped to the therapy, she continues to express her gratitude to us for the opportunity to participate in a clinical trial involving cutting-edge therapy.

How has the field changed over the years?

Clinical research nursing has gained momentum and visibility as the complexity of clinical trials has increased. Navigating acutely ill patients through the maze that is a clinical trial takes a special mix of organization, compassion, tenacity, creativity and curiosity.

What are the paths to becoming a CRN?

Nurses can get into clinical research through many different paths. They can join a local private practice that conducts clinical trials or go to work at a larger medical center. Usually, employers will provide on-the-job training and mentoring to help a new nurse orient to this role.

What education is required?

Typically, the minimum requirements for the CRN role are a BSN and one to two years of experience in clinical research and oncology nursing, ideally focused on one of the solid tumor or hematology diagnoses the posted job opening involves. With the American Nurses Association’s recent recognition of the clinical research nurse role as a specialty practice (back in 2016), more research institutions have established formalized orientation, onboarding and residency programs to ensure the success of nurses who may be new to the role.

At City of Hope, our clinical research nursing leaders have developed and implemented a three- to four-week onboarding program as an introduction to clinical research, coupled with 12 weeks of mentorship by a qualified CRN preceptor. Our leaders have also utilized the CRN Scope and Standards publication to educate and train us on our specialized role.

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How can staff nurses participate in research and learn if it’s something they find interesting?

Staff nurses often actively participate in clinical research — for example, by administering investigational drug therapies to patients under their care. Nurses who participate in a trial receive formal training in how to conduct activities for all active protocols.

If a nurse is interested in a particular therapy, he or she can speak with the clinical trial staff and ask questions to find out more.  Also, nurses can attend local and/or global seminars about new classes of treatments, whether in person or via webinars.

A number of my colleagues belong to the Oncology Nursing Society (ONS) and attend the organization’s annual congress, a week-long conference rich with oncology content, including updates on new drugs for cancer treatment.  Some research nurses are also affiliated with the International Association of Clinical Research Nurses (IACRN). This is another professional organization focused on the sharing of information and networking among nurses in the research field. Our department has presented poster abstracts and podium presentations at both ONS and IACRN conferences

What are some exciting research efforts underway at City of Hope?

Oncology clinical research is an exciting arena right now. CAR-T therapies are particularly in the spotlight. City of Hope has a very robust immunotherapy program that has allowed numerous patients to gain access to CAR-T and other cellular therapies.  As I mentioned, I have been involved with a CAR-T clinical trial for the treatment of multiple myeloma. The patients involved have often exhausted at least five or more lines of treatment without any sustainable response. After CAR-T cell therapy, it has been incredible to see patients go without any multiple myeloma treatment for upwards of five months because their disease is in remission!

Tell us about a new treatment that has changed your practice.

The recent approvals of checkpoint inhibitors for certain cancers have truly changed the way oncology patients undergo treatment. Checkpoint inhibitors use a patient’s own immune system to target cancer cells. These drugs seem to be well-tolerated by most patients and have demonstrated promising response rates.

What’s next in your career?

What would you like to learn or dig deeper into? I hope to eventually become part of a pharmacovigilance team in the pharmaceutical industry. These teams detect, research and monitor medication-related adverse events, assessing potential side effects, adverse reactions and interactions with other drugs. I would like to learn more about the FDA safety reporting guidelines and submissions so that I can break into this field.


Keith Carlson, RN, BSN, CPC, NC-BC, has worked as a nurse since 1996 and has maintained the popular nursing blog Digital Doorway since 2005. He offers expert professional coaching for nurses and nursing students at www.nursekeith.com.


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