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 manages a university-affiliated children's health system with the physicians and leadership of the University of California, San Diego (UCSD), Rady Children's Hospital, and Rady Children's Specialists of San Diego, a Medical Practice Foundation, unifying pediatric patient care, research, education and community service programs.

The Division of Genetics/Dysmorphology consists of 5 physician faculty members and 3 fellows who provide comprehensive care to children with genetic disorders. The group is dedicated to promoting excellent multidisciplinary care for these patients and to providing opportunitiesfor clinical research participation.

Under supervision, the Clinical Research Coordinator is responsible for coordinating and managing clinical trials including providing all aspects of protocol management, including but not limited to:

1. Recruitment and screening for patient eligibility,
2. Subject enrollment,
3. data collection,
4. Ensuring protocol compliance with local, state and federal regulations,
5. Filing adverse drug reaction reports with sponsor,
6. Monitoring patient treatment and toxicities,
7. Coordinating laboratory specimen collection and submission,
8. Maintenance of accurate and complete clinical research files,
9. Investigational Review Board submissions, renewals, and safety reports
10. Communicate with principal investigators, co-investigators and key personnel as needed, and
11. Reviewing and verifying research account statements, professional fee statements, and invoicing.
12. Performs other duties as assigned.

• 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 statistical software applications. Knowledge of database, word processing and spreadsheet applications such as Access, Excel and MS Word.

• Experience working with FDA policies regulating clinical trials.

• Experience in medical assessment and patient interviewing to determine eligibility.

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

• 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.

• Experience with clinical trials participant or study subject recruitment. Demonstrated ability to interact effectively with diverse groups, including professional and non-professional staff and clients.

• Experience coordinating study startup activities.

• Experience maintaining files and keeping records. Ability to work independently. Ability to maintain confidentiality.

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

• Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a diverse population. Excellent phone etiquette skills.

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

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

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

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

• Certification as a Clinical Research Associate or Coordinator.

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

• Occasional early mornings, evenings and weekends may be required.