The Department of Pediatrics is one of the largest departments within the School of Medicine with approximately 250 Faculty, 127 postdoctoral fellows (both MDs and PhDs) along with over 320 support staff (not including hospital staff). In addition, the Department has 68 clinical residents distributed across the Divisions. The missions of research, education, and patient care are intertwined and are integral to the goals of the department.

The incumbent will coordinate and oversee start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of subjects. Create informational and recruitment materials and act as a liaison with other UCSD departments and agencies for the purpose of implementation of studies. While the PI is ultimately responsible for the clinical trial, Clinical Research Coordinator (CRC) is responsible for the facilitation and coordination of the daily clinical trial activities in accordance with federal, state, and local regulations, Institutional Review Board (IRB) approvals, and UCSD/RCHSD policies and procedures. The CRC plays a critical role in the conduct of the study and works collaboratively with the entire Research team, sponsors, and monitors to ensure productivity and timely completion of studies.

The CRC provides direction and guidance to investigators. Provide education and information to the general public concerning the ongoing clinical trials. Assist PIs with proposals, progress reports, and manuscripts. Independently create original documents and policies for assigned disease teams. Work closely with federal and state regulatory officials. Performs other duties as assigned.

• 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.

• 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.

• Proven ability to find creative and innovative solutions to adjusting needs of the center. Ability to be resourceful and to understand the overall nature of work/responsibilities to establish useful resources and University contacts.

• 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.

• Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities. Meticulous attention to detail.

• 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.

• Phlebotomy experience.

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

• Occasional evenings and weekends may be required.