Director of Clinical Trials: Carlos Vega
Carlos Vega is the Director of Clinical Trials. He is responsible for the implementation of all operational aspects of clinical research within University Clinical Trials. As Director of clinical research Carlos provides the necessary leadership in the creation of a cohesive and integrated relationship among Clinical Research Organizations (CROs), sponsors and its clinical research staff members. Carlos is also accountable for leading the clinical research team to ensure that protocol/ study related activities are completed. This involves effective management and use of the appropriate tools to ensure the successful initiation, planning, execution, monitoring and completion of projects.
In addition, Carlos provides project and site management to ensure that studies are completed on time, within budget and in compliance with the site’s Standard Operational Procedures, FDA and International Conference on Harmonization- Good Clinical Practice (ICH-GCP) guidelines. Carlos also manages the completion of clinical trial agreements, budgets, contracts and IRB communications. Carlos is also HIPPA, ICH- GCP, and IATA certified and has various certifications on proficiency of using electronic data management systems. He is also highly skilled on data input, electronic medical records, source creation, and oversight of delegation of duties and responsibilities to the clinical research team.
Carlos has a foreign medical degree (MD) from Xochicalco University in Mexico and a bachelor’s degree in biology from UCSD. He is bilingual in Spanish and English and has contributed with Binational research in the San Diego/ Tijuana region. He has over 7 years of clinical research practice and has proficient knowledge in managing and interacting proficiently with global regulatory authorities. He has collaborated as a clinical research coordinator in phase I- IV studies, has elaborated in study design, protocol writing, analysis and interpretation of clinical trials data and the reporting of clinical trial results. Carlos has presented material at the annual Society of Clinical Research Associates meeting. He has provided leadership in over 40 clinical studies.
Clinical Research Coordinator: William Nahm
William Nahm is a clinical research coordinator with vast experience in computerized work flows. As a coordinator, William has managed many different studies, where he has made sure that all study-related activities abided by federal and agency regulations. With certifications in Good Clinical Practice, Protecting Human Research Participants, and HIPAA for healthcare professionals, William is a strong patient advocate who enjoys connecting with patients and bringing them comfort as he ensures their safety, rights, and health throughout a study. He is adept in recruiting and screening participants, obtaining informed consents, and protecting health information while conducting electronic data capture.
William has demonstrated leadership and versatility by taking initiatives to improve the efficiency of himself and his coworkers, coming up with satisfactory solutions to unanticipated problems, creating electronic source documents, and developing an inclusive work-environment that facilitates the effective training of study personnel. He has interacted with monitors, CRO’s, and sponsors to interpret protocol and report study results. William has combined the technology of his company, Havenomics, with University Clinical Trials to develop first-of-their-kind health-solution models. He is currently implementing an innovative health-advising program called myHaven at University Clinical Trials, which aims to radically improve the efficiency of patient recruitment and revolutionize the way patient’s interact with their healthcare providers.
Clinical Research Coordinator: Edison Gosoco
Edison Gosoco is responsible for the implementation of clinical research studies for drugs and information technology using clinical trials management software. He engages in collaborations with sponsors, CROs, monitors, federal agencies, and all study personnel to ensure that all patients’ rights, health, and safety are maintained. His primary focus is the maintenance of accuracy and integrity of data collection while ensuring compliance with the standards of clinical research within the health care industry.
Edison began his medical career as an information technology technician for University Dermatology Group while attending nursing school. After successfully completing his nursing program with honors, he worked at Cabrillo Surgery Center as a Recovery Nurse and information technology technician. Edison is a board-licensed vocational nurse with a BS degree working as clinical trials coordinator. He has certification in BLS for Healthcare Provider, ACLS, Medidata Rave, Shipping Dangerous Goods (IATA), and GCP.
Clinical Research Coordinator: Lindsay Osorio
Now, Lindsay is a lead clinical research coordinator at University Clinical Trials, and has been in charge of over 25 different studies dealing with various conditions such as acne, rosacea, alopecia, psoriasis, etc. Being a coordinator, Lindsay collaborates with sponsors, monitors, CRO’s and all study personnel to ensure that all patients’ rights, health, and safety are maintained as well as the accuracy and integrity of data collection. Some of her qualifications include being proficient in the process of informed consent, obtaining a GCP certification, and excelling in electronic data capture for various protocols. In addition, Lindsay is HIPAA certified, ensuring the privacy and security of our patients’ information always. Moreover, she proves her leadership in being subjects’ first point of contact in regards to communication, answering questions, and addressing any concerns that may arise. Lastly, Lindsay has protocol specific training and oversees regulatory documents to then be ready for real time submissions. While she obtains her training throughout the years, Lindsay is continuously learning to ensure all new regulations are applied. Lindsay is also fluent in Spanish.