Clinical Research Assistant/Interviewer - 133785

The Department of Pediatrics is one of the largest departments within the School of Medicine with approximately 171 Faculty, 50 post-doctoral fellows (both MDs and PhDs) along with over 300 support staff (not including hospital staff). In addition, the Department has 57 clinical residents and fellows 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 $106 million including sponsored projects expenditures of approximately $54 million and clinical revenue of over $ 52 million. This expansion of the Department's research and clinical portfolio is expected to continue in the next few years.

The Department's 18 divisions include Academic General Pediatrics, Child Development & Community Health; Allergy, Immunology and Rheumatology; Cardiology; Dermatology; Dysmorphology; Emergency Medicine; Endocrinology; Gastroenterology; Genetics; Genome Information Sciences; Hospital Medicine; Infectious Diseases; Neonatology; Nephrology; Pharmacology & Drug Discovery; Rehabilitation Medicine; 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.

Under supervision of Research Program Manager, the Clinical Research Assistant/Interviewer is responsible for coordinating and managing multi-site prospective pregnancy registry studies including providing all aspects of protocol management, including screening for patient eligibility, data collection, ensuring protocol compliance, adverse drug reaction reports, and maintenance of accurate and complete clinical research files. Responsible for recruitment and follow-up of pregnant women who take certain medications and vaccines, as well as comparison pregnant women without these exposures. The incumbent has knowledge of and is able to identify pregnancy exposure risks, has the ability to obtain and respond to very sensitive and personal health information over the telephone in a professional manner, as well as read and understand medical literature. The incumbent may promote the project at scientific and professional meetings, as well as distribute study materials to clinics in San Diego County.

• Theoretical knowledge of biology, microbiology, social sciences, clinical sciences as typically attained by a Bachelor's degree, or an equivalent combination of education and experience.

• Experience performing clinical research duties in a clinical research environment.

• Experience using database, word processing and spreadsheet applications such as Velos, Access, Excel and MS Word.

• Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities.

• Experience working with FDA policies regulating clinical trials.

• Experience in medical assessment and patient interviewing to determine toxicities related to protocol management. Ability to maintain confidentiality.

• Experience interpreting medical charts, experience in abstracting data from medical records.

• Experience with clinical trials participant or study subject recruitment. Experience coordinating study startup activities.

• Experience providing in-service training to various research personnel on protocols, processes, and procedures.

• Knowledge of x-rays, scans, and other diagnostic procedures.

• Excellent planning and organizational skills and ability to work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet deadlines efficiently and accurately.

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

• Demonstrated ability to interact effectively with diverse groups, including professional and non-professional staff and clients.

• Certification as a Clinical Research Associate or Coordinator.

• Experience working with research bulk accounts.

• Experience with investigational drug authorization criteria.

• Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens.

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

• Occasional evenings and weekends may be required.

• Scheduled work hours may vary as this project follows subjects residing throughout North America and time zone differences require availability outside normal day-time working hours. Ability have a fluctuating work schedule between the hours of 7:00 am and 6:30 pm Monday to Friday.