CTRI clinical coordinator Nancy Tang, standing next to a bed used for babies who are premature or very ill, provides services at the RCHSD Neonatal Intensive Care Unit. Photo by: Carlos Delgado
Described as the “heart and soul” of a research study, clinical coordinators work directly under a principal investigator to facilitate the safe and efficacious conduct of research involving human subjects. At UC San Diego Clinical and Translational Research Institute (CTRI), our eight clinical research coordinators assist in recruiting and screening study participants, ensuring continuity in data collection, maintaining data, and performing tasks such as obtaining and shipping specimens, and measuring vital signs. They perform these duties at the CTRI Center for Clinical Research and at UC San Diego and affiliated institutions, including Thornton Pavilion, the Medical Center in Hillcrest, and Rady Children's Hospital San Diego (RCHSD).
For the past year, CTRI clinical coordinator Nancy Tang has assisted RCHSD principal investigators with clinical trials ranging from diabetes in children and adults to standard-of-care drugs being administered to young children. She splits her time between type 1 and type 2 diabetes patients at the Endocrinology /Diabetes Clinic and premature and ill babies at the Neonatal Intensive Care Unit.
“I screen patients at the neonatal unit who were administered understudied drugs, and speak with their physicians and parents about possibly enrolling them in our studies to better understand the effects of a particular drug,” Tang said. At the Endocrinology/Diabetes Clinic, she assists type-1 diabetic children with testing a new Bluetooth enhanced glucose meter, as well as collects data about the family history of patients with type-2 diabetes, and draws blood for genetic testing.
She said the coordinators at CTRI are trained to be sensitive to the needs of not only the patients, but also the team they work with. “We are flexible and in constant collaboration with our principal investigators,” said Tang, who has been a clinical research coordinator for two years and is a certified phlebotomist.
Critical to Success
One of the researchers at RCHSD who Tang assists on pediatric clinical trials is Adriana Tremoulet, MD, Department of Pediatrics, UC San Diego and RCHSD.
“Nancy has helped with two of my pharmacology studies that are NIH funded. It has been a pleasure working with Nancy. She's thorough, kind and inquisitive,” Tremoulet said. “She has been responsible for screening for patients, providing informed consent/assent, collecting and processing samples, and entering the clinical and laboratory data into the study's database. Her help has been critical to the success of this project.”
CTRI clinical coordinator services are provided on an hourly basis or can be assigned at a percent effort to an individual investigator for a specified period of time, and may be tailored to support a single service or multiple services. “Researchers often refer to our services as cost-effective because we provide services and fees based on what is needed by the PIs, which varies from the beginning to the end of a study, the continuation of a study, or closeouts,” Tang said.
At CTRI's Center for Clinical Research (CCR), the clinical coordinators work on studies that range from drug therapy for liver cancer to metabolic studies, with duties that encompass scheduling subject visits and managing data bases to measuring vital signs, drawing blood samples, and performing EKGs and lab work. The CTRI clinical research coordinators support approximately 100 clinical trials every year.
“The clinical research coordinator is a specialized research professional working with and under the direction of the clinical principal investigator,” said Maeve Taaffe, the Nurse Manager at the CCR.
CTRI clinical coordinator Lakisha Bush
Taaffe said that while the principal investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the clinical research coordinator supports, facilitates and coordinates the daily clinical trial activities, and plays a critical role in the conduct of the study. “By performing these duties, the clinical research coordinator works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study,” she said.
At the CCR, clinical coordinator Lakisha Bush meets weekly with participants in a 12-week double-blind study testing the effects of the drug ADI-PEG 20 on hepatocellular carcinoma cancer in the liver. The Polaris Group, a biopharmaceutical drug company, developed the drug.
Bush, who supports UC San Diego principal investigator Yuko Kono, MD, on the study, begins by helping a potential participant with the consent form. At the initial meeting, she also takes the participant's vitals, draws blood, schedules a CT scan that will determine if the participant's liver lesions qualify for the study, and sets up a physical for the participant. “I go over their medical histories, take blood and process the samples, and set up appointments at Radiology and at the clinic,” Bush said.
Once the participant qualifies and is enrolled in the study, Bush monitors the participant before and after the weekly drug injection, checking the participant's heart rate, blood pressure, temperature, and respiration, and performing EKGs on selected visits. “The observation is teamwork with the RN, who injects the participant with the drug or placebo,” Bush said. The clinical coordinator is also responsible for scheduling additional CT scans later in the study, as well as performing blood work and assessments during the weekly visits and ordering the prescribed drugs for the injections.
CTRI clinical coordinator Laura Hernandez
Single or Comprehensive Tasks
One of the advantages of using CTRI's clinical research coordinator services is that the coordinators are available to travel to all of the UC San Diego medical facilities and affiliated facilities, and can be contracted to perform a single task or comprehensive tasks related to a study.
CTRI clinical research coordinator Laura Hernandez has been on assignment at the UC San Diego Medical Center in Hillcrest since December, assisting Rohit Loomba, MD, on three liver studies. Hernandez's days are varied, with tasks ranging from scheduling MRIs, CT scans, biopsies and physicals to performing ultrasounds, reconciling drugs, and ordering prescriptions. On one of the studies, “Heritability of Fatty Liver as Measured by MRI: a Cross Sectional Study of Twins and Family Members,” Hernandez schedules MRIs, takes family histories, and measures vital signs.
“Our job is to provide clinical research services requested by PIs,” Hernandez said. “This can include the entire study or whatever sections are needed. I have done entire studies from the beginning to the end, as well as a study that just required collecting blood samples and walking them to a courier.”
Strengthens UC San Diego and Rady Children's Hospital Partnership
Christina Chambers, PhD, said the CTRI clinical research coordinator services provided at RCHSD strengthens the partnership between UC San Diego and RCHSD – a partnership that smooths the path for pediatric research. Chambers is the Director of Clinical Research at UC San Diego's Department of Pediatrics and Associate Director, CTRI Center for Clinical Research at Rady Children's Hospital. She began serving on the CTRI Executive Committee 18 months ago.
Through the UC San Diego-RCHSD partnership, all pediatricians at RCHSD have faculty appointments at the UC San Diego School of Medicine. “We're developing ways for RCHSD and UCSD to make the best use of resources available and support investigators in a seamless and efficient way to support the growth of clinical research at Rady Children's Hospital,” Chambers said. “The clinical coordinator service is one of those ways.”
“The advantages of having a CTRI presence at RCHSD is that we are able to use the knowledge we've learned through working with various age groups, hospitals, and different kinds of studies, and apply them to the research studies we conduct at Rady's,” added Tang. “This helps RCHSD build a stronger research team.”
Read more information about CTRI's clinical coordinator services.
A planned clinical trial of stem cells to treat paralysis from spinal cord is using CTRI clinical coordinator services. Read the UT-San Diego story here.
Written by Patricia Wieser
About UC San Diego Altman Clinical and Translational Research Institute:
UC San Diego Altman Clinical and Translational Research Institute (ACTRI) is part of a national Clinical and Translational Science Award consortium, led by the National Institutes of Health National Center for Advancing Translational Science. Established in 2010, ACTRI provides infrastructure and support for basic, translational and clinical research throughout the San Diego region to bring discoveries from the laboratory to the bedside, and facilitates training and education of the next generation of researchers. ACTRI carries out its activities in collaboration with institutional and corporate partners and currently has more than 1,500 members.