Description:
The Regulatory Coordinator provides clinical and administrative support to the Division of Pediatric Emergency Medicine (DoPEM) for research activities within the research enterprise. The incumbent will organize, coordinate, and oversee regulatory, compliance, clinical and administrative details of research activities for multiple projects while achieving the project objectives and maintaining the integrity and compliance to a host of department, university, and federal rules and regulations.
University of Utah Job ID# PRN14487B, Pediatric Emergency Medicine
WORK SCHEDULE: Full time, 40 hours/week, Monday – Friday, business hours with occasional evenings and weekends. Shared on-call responsibilities.
COMPENSATION: $39,300 to $56,000 DOE. Strong benefit package including tuition reduction program, retirement and health plan options.
RESPONSIBILITIES:
• Prepares and submits all initial, renewal, and study closure reports to the IRB, OSP and any other regulatory agencies.
• Tracks study approvals, updates, and expirations to ensure uninterrupted project progress.
• Tracks sponsor and PI-initiated amendments, submits amended protocols, summaries, and consents to the IRB.
• In conjunction with PI, ensures that the rights and welfare of research participants are protected in accordance with federal and institutional guidelines.
• Completes, audits, and maintains study records, materials, and databases to ensure compliance with study protocols, FDA, IRB, departmental, and university regulations.
• Tracks adverse events. Reports serious adverse events and protocol violations to IRB and sponsor.
• Assists PIs and other research staff with research process and policy issues, also provides regulatory process guidance and teaching.
• Assists with preparation of grant applications and management of awarded contracts. Works with OSP and GCA to oversee budgetary expenses.
• Maintains current knowledge of federal and institutional guidelines and requirements governing research.
• Maintains division-specific regulatory binders and tracking database.
• Recommends and implements regulatory process improvements to managers, PIs, and other study personnel.
Clinical Research Coordinator
• Coordinates research projects and activities. Oversees day-to-day clinical research to guarantee the effective follow-through of study protocols and identified goals.
• Collaborates with the project PIs to identify research project goals, assess protocol for clarity and subject safety, review inclusion/exclusion criteria, and then designs a system to accomplish these goals within study time frame and budget constraints.
• Supports preparatory study activities by designing site workflow and study training programs.
• Meets often with PIs, managers, and other research personnel to update overall study progress and make modifications as needed.
• Designs documents, devices, tools, and educational programs and systems to ensure proper patient capture and facilitate accurate data collection.
• Ensures the quantity and quality of data meets specific project objectives. Maintains validity and verifies accuracy of data.
• Obtains informed consent, medical history and demographics; documents and maintains historical data, status reports, progress notes, and subject logs.
• Participates in shared on-call responsibilities for enrolling study patients in the ED.
• Assists in training, oversight and mentoring of research assistants. Assists in developing and documenting research education programs for clinical staff.
• Pursues additional research education opportunities by attending Research Administration Training Series.
• Performs other necessary research support functions as assigned by PI, manager, clinical research coordinator, or division chief.
Team Player
• Attends and participates in division Career Development meetings.
Demonstrates initiative, enthusiasm, positive attitude, teamwork, and commitment to the research mission of DoPEM and the department by providing assistance and support as needed and where directed.
Qualifications:
QUALIFICATIONS: Bachelor’s degree in a research or related area plus two years clinical trials/research experience or equivalency required; demonstrated human relations and effective communication skills also required. One year of regulatory experience, an understanding of medical terminology and technical writing experience preferred.
PREFERENCES:
• Experience with IRB and other regulatory processes, protocols, procedures, data collection, etc.
• Regulatory and administrative experience organizing and coordinating multiple research projects running simultaneously
• Basic understanding of emergency medicine clinical practices and medical terminology
• The ability to effectively communicate and work with research regulatory agencies, research subjects, and personnel at all levels
• Working knowledge of research software programs and large databases
• IRB CITI Course in the Protection of Human Research Subjects certificate required; CCRC certification or equivalent preferred. Must have after one year of employment
Applicants will be screened according to preferences.
Application Instructions:
PLEASE APPLY ONLINE THROUGH THE UNIVERSITY OF UTAH SYSTEM TO BE CONSIDERED FOR THIS JOB: http://utah.peopleadmin.com/postings/65596
EQUAL EMPLOYMENT OPPORTUNITY
The University of Utah is an Affirmative Action/Equal Opportunity employer. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities. Please contact the Office of Equal Opportunity and Affirmative Action, 201 S. Presidents Cr., Rm 135, (801) 581-8365 (V/TDD), for further information or to request an accommodation. The University of Utah is committed to diversity in its workforce. Women and minorities are encouraged to apply.