Description:
Coordinates the implementation, quality control and completion of research studies in the Division of Pediatric Inpatient Medicine while assisting Principal Investigators in determining and accomplishing study objectives. Oversees research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies.
University of Utah Job ID# PRN15106B, Pediatric Inpatient Medicine
COMPENSATION: $39,300 to $64,349 DOE. Strong benefit package including retirement and health plan options.
WORK SCHEDULE: Full-time, 40 hours/week, Monday–Friday, 8:00 a.m. to 5:00 p.m.; occasional nights and weekends may be required, although rare.
RESPONSIBILITIES:
• Coordinates research projects, both within the Division and outside the Division; oversees project operations while supporting principal investigators’ end goals.
• Assists Principal Investigators in the development of study protocols, grant applications, development and maintenance of content for specific interventions and tools employed for the study (e.g., web sites, mobile applications, educational materials etc.).
• Good understanding of grant application processes, budgeting and accounting related issues, including collection of essential documents such as letters of support, investigator biosketches, developing budgets and budget justifications, and assembling all needed documents for submission.
• Oversees compliance to protocols; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies.
• Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
• Coordinates project meetings between investigators, stakeholders, and advisory committee members.
• Coordinates communications with sponsored agencies, documenting changes to protocols, seeking and receiving approvals of the changes from the sponsors, and preparing interim and final reports.
• Strong ability to work independently with various stakeholders and investigators, and to successfully accomplish multiple responsibilities, including ensuring compliance with protocols, completing IRB applications/renewals, recruiting study participants, ensuring timely data collections and communication with stakeholders, funding and regulatory agencies.
• Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance. Coordinates and performs responsibilities related to research participants including determining subject population availability, developing informed consents, surveys, data collection instruments and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits and acting as a liaison between participants and study-related parties.
• Prepares, submits and maintains IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence.
• Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
• Develops study budgets; monitors budget expenses and billing for allied services; negotiates payment schedule with sponsor and fees for internal services.
• Recognizes, tracks and reports adverse events and protocol deviations.
• Prepares for and coordinates site visits made by sponsors or federal agencies during course and at the close of the study.
• Represents the research program at meetings.
• Mentors and trains new or junior research staff.
Qualifications:
• Bachelor’s degree in a health sciences or related field with two years professional research experience and completion of University RATS Clinical Certification within one year of hire required. Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills also required.
• Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently is preferred.
• Departments may require IRB CITI Course or IATA DGR training within a specified timeframe.
• Departments may prefer a nursing degree for this position, which requires the incumbent to have two years related experience and possess a nationally recognized research compliance certification.
PREFERENCES: Master’s degree and/or nursing degree preferred but not required.
Application Instructions:
PLEASE APPLY ONLINE THROUGH THE UNIVERSITY OF UTAH SYSTEM TO BE CONSIDERED FOR THIS JOB: http://utah.peopleadmin.com/postings/68271
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.