Clinical Research | Phase I Clinic

START Patient Care

At START, we provide quality data through timely enrollment of study participants. The Phase I Clinic staff is comprised of a variety of specialized team members including Registered Nurses, Licensed Vocational Nurses, Medical Assistants, Front Desk Schedulers, Research Nurses, Study Coordinators, Clinical Research Assistants, and Medical Records Technicians all dedicated entirely to the Phase I program. Staff members are trained in Good Clinical Practices (GCP) and are also highly experienced in the field of oncology. Certifications held within the department include Oncology Certified Nurse (OCN), Advanced Cardiac Life Support (ACLS), Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), Registered Health Information Technician (RHIT) and Registered Health Information Administrator (RHIA).

The Director of Phase I Nursing, Leslie Smetzer, holds a Bachelor of Science degree in Nursing, is an Oncology Certified Nurse and has over 20 years of oncology as well as 15 years in Phase I clinical trial experience.

Exam

The exam area at START includes 10 exam rooms for our clinical trial participants. Using state-of the-art wireless technology and a physician data capture system, our highly trained physicians are able to assess patients at bedside to document, grade, attribute adverse events, and enter the data digitally into our electronic medical record (EMR). This permits accurate assessment at point of contact.

Treatment

Phase I Clinic ExamThe START clinic has a research dedicated treatment room for clinical trial patients. This area includes 21 treatment chairs and 3 bed/gurney areas. The treatment staff consists of Registered Nurses who provide direct patient care and include OCN and ACLS certified RNs. They provide IV infusions and oral medications as well as obtain pharmacokinetic, pharmacodynamic and other specimens required during treatment and observation periods.

The START clinic has uninterrupted digital cardiac monitoring capabilities in early and late development clinical studies. At START we utilize a wireless Holter monitoring system for cardiac and QTc evaluations.

Research Nurses / Study Coordinators

Phase I Clinic Research Nurses and Study CoordinatorsThe Research Staff consists of Research Nurses and Study Coordinators who are responsible for protocol management, communication with study sponsors, and patient care. Our research staff is responsive to both patient and study sponsor needs. Each study is assigned a research team member to ensure continuity of care for study patients as well as the needs of the study sponsor. The research staff is closely involved with patient screening, enrollment, education, and patient follow up. They maintain constant communication with study sponsors, physicians, clinical staff, and patients.

Data Management

Phase I Clinic Data ManagementSTART’s data management team consists of experienced Clinical Research Assistants (CRAs) that are responsible for paper and electronic case report form (CRF) completion, and query resolution. The team is highly knowledgeable with electronic data capture (EDC) systems, such as, Medidata Rave, InForm, Oracle Clinical, and Synteract. The CRAs are also responsible for coordinating all aspects of monitoring visits at START. The team is held to the upmost internal standards to ensure a quality and timely product for the study sponsors. Our data management team undergoes quality and timeliness assessment with the study sponsor at every exit interview to ensure quality standards are maintained.

Contact

Leslie Smetzer

Leslie Smetzer, BSN, RN, OCN
Director, Phase I Nursing
START 4383 Medical Drive, Suite 3042
San Antonio, TX  78229
Phone:  (210) 593-5269
Fax:  (210) 615-1074
E-mail: leslie.smetzer@start.stoh.com