Clinical Trials Study Team
Diane Barrett, MS, CCRP, completed her degrees and trained as a registered nurse and health visitor in England. She has been coordinating pediatric vaccine clinical trials since the beginning of our program in 2001, and is skilled in all aspects of protocol initiation and management. She is responsible for strict adherence to the protocol at both study sites, develops materials for subject recruitment, implement strategies for subject retention, coordinate subject follow-up activities and focus on data quality. She is responsible for IRB and FDA communications and for prompt attention to queries, as well as compliance with regulatory requirements.
Barbara Box-Jones, PA-C, began her medical career as a paramedic. When she became a PA in 1982, her focus was the primary care setting. She is a calming presence in our group. Barbara's diverse experience is of great benefit in clinical trials.
Gerianne Casey, RN, has over 20 years of clinical trials experience, including study coordination, data management, IRB and regulatory experience. She has been the lead coordinator for the DMID CMV vaccine study since 2008, and was also instrumental in the success of the Phase 1 universal influenza vaccine and smallpox vaccine studies. She is also responsible for strict adherence to the protocol, developing materials for subject recruitment, implementing strategies for subject retention, coordination of subject follow-up and high quality data. She assists in IRB and FDA communications and for prompt attention to queries, as well as compliance with regulatory requirements.
Phyllis Galatas, RN, has over 10 years experience as research nurse, including the UTMB AIDS Clinical Trials Group before joining the SCVD CTG where she has been involved in DMID Trials. She is involved in subject recruitment, coordinating follow-up visits, performing blood draws on subjects, and undertaking study visits. She is a study coordinator at the Galveston site.
Peggy Haardt, PA-C, has over thirty-five years of experience as a Physician Assistant and ten years with clinical trials. The support and advocacy that she provides our group is invaluable. Peggy's experience is especially helpful with our pediatric populations.
Carrie Harrington, RN, CCRP, has worked with the SCVD Clinical Trials Group for more than 5 years. She has successfully recruited for and coordinated Phase 1 studies for a universal influenza vaccine, a smallpox vaccine, and an H5N1 vaccine. She has also been closely involved with many other studies in various age groups from infants to older adults. Ms. Harrington is very familiar with the requirements for DMID projects, and with the EMMES data management system. She is currently lead coordinator for a Phase 1 Dengue virus vaccine study. She has a key role in subject recruitment, coordinating follow-up visits, performing blood draws on subjects, designing data collection forms and supervising data transfer into the computer database. Ms. Harrington is also responsible for coordination of the laboratory requirements, critical for the success of protocols.
Kristin Pollock, RN, initially joined our group in 2007 to coordinate studies in the neonatal nurseries but has since branched out into vaccine trials. She was the lead coordinator for a neonatal candidiasis prevention study, comparing fluconazole to placebo, in the Neonatal Intensive Care Nursery (NICU), before taking the lead for some infant vaccine studies. At present she is the lead coordinator for the DMID 08-0017 Sequential Rotavirus Vaccine Series at the UTMB pediatric clinic in League City so is also well-versed in the EMMES data management system. Ms. Pollock has been the unblinded vaccinator for several studies and is knowledgeable about all aspects of vaccine receipt, accountability and storage at the site. She is experienced in the HSROAD Order-It system and trained in DMID Pharmacy Guidelines.
Marianne Shafer, BA, CCRP, has experience as a clinical research coordinator with experience in project coordination, scheduling, education, phlebotomy, and data management, as well as patient communication. She assists with study visits particularly during the busier periods of the study when her phlebotomy skills are utilized and she also helps with making appointments, phone calls, diary reviews and data entry.
Lori Simon, RN, BSN, CCRP, has been involved in clinical research since 2003. She has participated in 11 vaccine clinical trials since joining our group in 2009, and has been lead coordinator for 2 pneumococcal vaccine trials. She successfully recruited 48 infants into one of those trials and 22 healthy adults, aged 50+ years, into the other one. She works closely with the staff in the pediatric clinic to identify possible study participants and is a skilled pediatric phlebotomist. Ms. Simon has worked on previous DMID projects, and is currently lead coordinator for the DMID 08-0017 Sequential Rotavirus Vaccine Series at our island pediatric clinic, and is familiar with DMID requirements and experienced with EMMES data management.