Under general supervision, the Trauma/Burn Clinical Research Assistant works with UCSD faculty and principal investigators in the management of study participants enrolled in clinical trials related to the study of trauma, burn, and wound treatments. The incumbent assists the P.I. and responsible clinical research nurse in management of clinical trials activities, functions as study advocate, coordinates IRB correspondence, reviews IRB documentation before submission, documents participant progress, assists with human subjects recruitment and screening, and interacts and works effectively with others. Performs standard study procedures according to protocol and analyzes results. Engages in research study and protocol coordination, performs database design and coordination, and performs data collection and quality assurance all in compliance with research protocols and procedures. Leads monthly burn research meetings with PIs to update study staff on Burn protocols and research subject progress. Trains and advises staff with wound protocols, UCSD research guidelines, IRB procedures and various other research coordinator related tasks.

• Strong theoretical knowledge and/or Bachelor's Degree in a social science or basic science such as Biology, Microbiology or a related field and/or an equivalent combination of education and work experience.

• Demonstrated experience in clinical trials research. Strong knowledge of experimental protocols, data gathering, protocol design and evaluation.

• Demonstrated experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures. Strong experience in clinical trials research including budget negotiations and invoicing per clinical trial agreement.

• Strong knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation).

• Demonstrated experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital.

• Experience in providing work direction and assisting supervisor in maintaining an efficient medical research team.

• Strong knowledge of investigational protocols especially with pediatric oncology protocols (data management, query resolution, protocol design, protocol writing and protocol implementation).

• Demonstrated experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.

• Strong experience completing clinical trials case report forms via hard copy and online.

• Ability to discern items that can be handled independently and those which require attention of supervisor, including ability to quickly determine subject matter of material and necessary action to be taken in a timely manner.

• Working knowledge of medical and scientific terminology.

• Computer proficiency, including working knowledge of word processing, spreadsheet software (Microsoft Office) and internet browser applications. Experience in conducting searches on the internet.

• Demonstrated administrative experience, skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions.

• Knowledge of cost accounting as applied to both University and Medical Center functions. Demonstrated knowledge of medical billing and collections guidelines and procedures.

• Possess a Clinical Research Coordinator Certificate, or Masters Degree.

• Employment is subject to a criminal background check and pre-employment physical.

• Occasional evenings and weekends may be required.