The Director of Regulatory and Clinical Data Management will be responsible for the oversight of all regulatory activities associated with clinical trials managed by the Clinical Research Administration (CRA) division for the University of Kansas Medical Center Research Institute.
The Director of Regulatory and Clinical Data Management will be expected to play a major role in the development of standard operating procedures, IND/IDE applications, and in strategic efforts to expand Clinical Research Administration.
Additionally, this position will be responsible for the planning, coordination, control and continuous improvement of processes and methods used to regulate the quality of clinical research activities.
As a member of the Clinical Leadership Team, the Director of Regulatory and Clinical Data Management will be expected to play a major role in strategic efforts to provide high quality clinical research services to existing and future clientele.
Oversee all regulatory activities for clinical trials to ensure studies are completed on time, within budget and in compliance with standard operating procedures, FDA regulations and ICH/GCP guidelines.
Coordinate regulatory functions of multi-site clinical trials.
Direct supervision of the Regulatory and Clinical Data Management team.
Provide leadership and guidance with respect to clinical trial functions.
Oversee, plan and implement internal training programs and workshops for Regulatory and Clinical Data Management staff.
Create Standard Operating Procedures (SOPs) as needed to support compliance.
Write and/or implement changes/updates to controlled documents (e.g., SOPs, methods and policies).
Participate in various projects/events promoting the services of Clinical Research Administration to University of Kansas Medical Center faculty.
Facilitate the dissemination of staff work assignments (i.e., disease groups).
Develop strategies/processes to enable Regulatory and Clinical Data Management staff the ability to anticipate and successfully adapt to regulatory changes.
Make recommendations and serve in an advisor role.
Be able to identify problems and trends as well as structure appropriate responses.
Oversee internal auditing processes/procedures.
Ensure that PI-initiated clinical trials are monitored on a regular basis for quality and accuracy of regulatory data.
Conduct audits of study activities and documentation including consent forms, regulatory documents, approval letters and adverse-event reporting.
Be able to identify trends, as well as structure appropriate responses.
Ensure that the data entered into the VELOS database undergoes routine quality assurance reviews.
Provide assistance and guidance to physicians and investigators in preparation for FDA audits with respect to document reconciliation for specific trials.
Participate in pre-initiation site visits and monitoring visits.
Review monitoring letters and provide training as needed.
When necessary, this position may perform the core duties of a clinical trial project manager.
Create databases and reports for executive leadership.
Work in conjunction with Informatics and Enterprise Analytics (University of Kansas Medical Center) and other database administrators to ensure the accuracy, proper functionality and development of all reports within divisional systems (i.e., VELOS).
Review all database reports on a weekly basis.
Provide oversight and management of ClinicalTrials.gov; manage dashboard activities in concert with Informatics and Enterprise Analytics (University of Kansas Medical Center).
Participate in research education opportunities and provide teaching/training for study coordinators, clinical trials administrators, administrative trial coordinators and principal investigators as requested.
Assist in planning of Clinical Trials Education Lecture Series (CTELs) and Clinical Trials Education Classes (CTEC).
Review monitoring letters and recommend opinion-based training, as needed.
Partner with the Office of Research Communications and Education within the University of Kansas Medical Center to conduct clinical research orientation/registration programming for new investigators and study coordinators.Apply at
Location/Region: Fairway, KS