Scheduled Hours

40

Position Summary

Under the direction of the Vice Chairs of Clinical Investigation and Director Research/Business Administration this position is responsible for providing leadership within the Department of Pediatrics clinical research enterprise and responsible for the clinical research activity of the Pediatric Clinical Research Unit (PCRU).

Job Description

Primary Duties & Responsibilities:

Pediatric Clinical Research Unit Oversight

• Manages the PCRU and the day-to-day functions of the unit.
• Recruits, hires, trains, manages and reviews clinical research staff.
• Makes recommendations and participates in the development of and implements decisions and policies and procedures for the PCRU.
• Monitors financial performance of the unit and helps develop rates.
• Monitors compliance of the clinical research division with the IRB, federal mandates, grant and industry compliance; identifies areas needing improvement and suggests solutions to problems.
• Assists with compliance monitoring and audits.
• Aids in the strategic planning of the PCRU.
• Responsible for research education and training of clinical research staff to include the development of a research manuals and training program to maintain research compliance.
• Ensures regulatory compliance across studies.
• Collaborates with sponsors and clinical research teams on various initiatives.

Provide Leadership Within the Department of Pediatrics Clinical Research Enterprise

• Assists study teams with the completion of site feasibility questionnaires.
• Provides guidance to Research Administrators and Clinical Research Team Members on Industry Clinical Trial budget development.
• Assists Research Administrators and Clinical Research Team Members with clinical study billing and requests from industry sponsors.
• Acts as liaison between Department of Pediatrics and Center for Clinical Studies when appropriate.
• Acts as liaison in matters relating to clinical research activities between the department, ICTS, the School of Medicine and external agencies.

Data and Biostatistics Support

• Assists with data requests.
• Shares with Investigators Biostatistics resources available.
   

Training, Education, and Quality Improvement