Jacqueline A.

Coordinated Multiple Sclerosis clinical research projects in the department of NeuroImmunology located at Altman Clinical and Translational Research Institute (ACTRI). • Managed all operational aspects for implementation of clinical trial activities from study start-up through closeout visit, ensuring Good Clinical and Documentation Practices (GCP/GDP) and relevant Standard Operating Procedures (SOPs) were met. • Provided direction and guidance in the execution of clinical research and propose solutions and strategies to resolve any issues that might arise. • Local and Central IRB submissions and administration. Worked closely with reliances at UCSF, Johns Hopkins, state and federal regulatory officials and pharmaceutical sponsors to ensure compliance with all study-related activities. • Coordinated and managed NeuroImmunology Phase I-III trials. Carry out all aspects of trial management including screening for patient eligibility, scheduling of trial events, protocol compliance, adverse event reporting, monitor subject treatment, pharmacokinetic collection, and accurate data capture. •Lead oversight of activities related to site selection, initiation, conduct and closure. • Served as a liaison between pharmaceutical companies, contract research organizations, regulatory agencies, physicians, and clinical team to ensure trials are executed in compliance with GCP, FDA and ICH guidelines. • Trained and supervised study personnel in clinical trial management and documentation.

Responsible for coordinating and managing Head and Neck carcinoma clinical trials, including providing all aspects of protocol management such as screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files. Provide direct assistance to Head and Neck oncologist on phase I-III immunotherapy trials. Responsible for sub site start up procedures and remote monitoring for PI Intiated clinical trials in 4 NCI designated cancer clinics. Assist the Regulatory Department with human subjects submissions, renewals, and safety reports. Directly communicate with assigned physicians and disease groups, including attending weekly meetings and tumor boards. Provide direct assistance to the Project Manager in reviewing and verifying university research account statements, professional fee statements, and invoicing.

Responsible for recruitment, administering informed consent, and follow-up of pregnant women who take certain medications and who enrolled in multi-site prospective pregnancy registry studies. Independently identified high risk pregnancy exposures by analyzing information collected from subjects and used this information to determine enrollment status. Reviewed and abstracted pertinent medical information in order to help the study manager determine reportable serious adverse events (SAE) such as major and minor congenital malformations. Provided quality assurance for participants’ study data by reviewing medical records and updating/editing database entries Provided training for individuals in the Research Assistant position which included training on study protocols and study conduct.

The National Children’s Study examined environmental influences on children’s health and development. The goal of the Study was to improve the health and well-being of children and help understand the role various environmental factors have on health and disease. The Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health (NIH) was tasked by Congress to design and lead this research project.

Responsible for the recruitment, training, and supervising of 10-14 research staff. Coordinated the hiring process for 50+ employees, reviewed resumes, interviewed applicants, and worked with SDSURF HR with hiring procedures. Planned new employee training and assisted with the development of the studies policies and procedures manuals and SOPs. Coordinated the launch of door to door household recruitment for 4 neighborhoods in San Diego County. Planned weekly team meetings, motivated, and shadowed staff in the field weekly to ensure compliance with research protocols. Prepared weekly & monthly reports for pilot project. Coordinated with data management supervisor to decrease data entry error and worked closely with retention supervisor to ensure the studies objectives were being met and protocols followed. Completed enumeration, interviews, and informed consent process for participants eligible to join study using various recruiting strategies. Conducted telephone interviews and kept data entry updated and organized.

Screening, Brief Intervention, and Referral to Treatment (SBIRT) is a comprehensive, integrated public health approach to identify and deliver a spectrum of early detection and intervention services for substance use in general medical care settings. These settings, such as emergency department visits, offer a potential "teachable moment" because patients may have perceptions of vulnerability about their health, and therefore be particularly receptive to screening and counseling. There is mounting scientific evidence suggesting SBIRT is effective in reducing alcohol use at varying levels of severity in a myriad of health care settings including primary care, emergency departments, and trauma centers.