Clinical Research Coordinator - 133775

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 Department has undergone significant growth in recent years with a consolidated budget of approximately $183 million including sponsored projects expenditures and clinical revenue. Expansion of the Department's research and clinical portfolio is expected to continue in the next few years.

The Department's 16 divisions include Academic General Pediatrics, Child Development & Community Health; Allergy, Immunology and Rheumatology; Cardiology; Dysmorphology; Emergency Medicine; Endocrinology; Gastroenterology; Genetics; Genome Information Sciences; Hospital Medicine; Host-Microbe Systems and Therapeutics; Infectious Diseases; Neonatology; Nephrology; and Respiratory Medicine.

In 2001, physicians and leadership of the University of California, San Diego (UCSD), Rady Children's, and Children's Specialists of San Diego (CSSD) unified pediatric patient care, research, education and community service programs, creating a university-affiliated children's health system to serve the region. Over the past two decades, an extensive list of joint programs has developed, with many physicians and researchers playing a role at both institutions.

This affiliation has consolidated the clinical, teaching, research and public service programs of the UCSD School of Medicine's Department of Pediatrics with San Diego's only health care system dedicated to the health and well-being of children. In 2009, this partnership was furthered by the creation of Rady Children's Specialists of San Diego, a Medical Foundation, and is now recognized as having global leaders in research, technology, translational medicine, education and clinical excellence.

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 departments and agencies for the purpose of implementation of studies. The Clinical Research Coordinator will plan, develop and implement start-up procedures for multiple phase I-III research studies in assigned disease team as well as lead, direct, and coordinator operational efforts. Assure compliance with state and federal regulatory guidelines. Oversee the quality of the medical and clinical research data. Provide direction and guidance to investigators. Provide education and information to the general public concerning the ongoing clinical trials. Assist PI 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 sciences or basic sciences 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 especially with pediatric protocols (data management, query resolution, protocol design, protocol writing 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.

• 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.

• 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 (ACRP-CCRC).

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

• Occasional evenings and weekends may be required.