This is a UC San Diego Internal Recruitment open to UCSD Pediatrics employees only.
UCSD Layoff from Career Appointment: Apply by 04/08/21 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 04/13/21. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The Department of Pediatrics is one of the largest departments within The School of Medicine with approximately 164 Faculty, 72 post-doctoral fellows along with over 300 support staff (not including hospital staff). In addition, the Department of 110 clinical residents and fellows are 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 $138 million including sponsored projects expenditures of approximately $65 million and clinical revenue of over $73 million. This expansion of the Department's research and clinical portfolio is expected to continue in the next few years.
The Division of Dysmorphology and Teratology is involved in four major areas: 1) providing clinical services to patients with birth defects and developmental disabilities, 2) providing public health services in counseling patients, providers and education to the public about pregnancy and lactation exposures and their impact on child development and health, 3) a teaching program that includes undergraduate students, graduate students in epidemiology, medical students, and post -doctoral students, pediatrics, epidemiology, health behavior, global health, pharmacy, and other specialties; and 4) conducting clinical research to better understand the causes, prevention and treatment of birth defects and developmental disabilities. Research programs and projects within the Division involve federal, state and industry sponsored grants and contracts totaling over $40 million. These encompass national and international studies that require complex interrelated infrastructure and shared resources both within the Division and with collaborators and subcontractors outside the Division.
The Research Trials Regulatory Specialist is responsible for the development and maintenance of regulatory documents pertaining to the 50+ research trials conducted by investigators in the Division of Dysmorphology and Teratology. Key to this role is the preparation of research trial protocols and related regulatory documents for submission to the UCSD Human Research Protections Program (HRPP/IRB) in order to obtain approval for the trials to proceed. The Regulatory Specialist will act as a resource to investigators and staff for interpretation and execution of complex regulations, policies and procedures concerning the conduct of research trials, including those of the FDA, HHS, and the UCSD HRPP/IRB, advising on potential issues of concern and ensuring that the Division's research projects are in compliance with the policies and procedures of campus, state and federal HRPP regulatory agencies as well as the Health Insurance Portability and Accountability Act (HIPAA). This position requires regular interaction with a variety of internal and external contacts including Division investigators and staff, UCSD HRPP/IRB staff, study sponsors and/or their representatives.
Using research compliance concepts, applies organization policies and procedures to review and /or pre-review moderately complex, minimal risk research protocols. Works independently in most cases without a great deal of supervision or oversight for routine or standard assignments. Occasionally pre-reviews or highlights potential issues of concern for department heads or committee members to consider in their review of research protocols that qualify for full review.
Six (6) years of related experience, education/training, OR a Bachelor's degree in related area plus two (2) years of related experience/training.
Knowledge of relevant Federal and State regulations, and policies.
Working knowledge of UCSD Human Research Protections Program (HRPP/IRB) policies and procedures.
Ability to solve problems, issues; listen, interpret and confirm understanding of others' communications; and be objective.
Effective, efficient and tactful oral and written communication skills.
Ability to work in a team oriented setting, to prioritize work, and to follow through on routine assignments with minimal direction.
Proficiency with computers, including the ability to operate personal computer software with sophist
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