IIT Research Program Coordinator - CTO

The University of Oklahoma•Norman, OK

45d

About The Position

OU Health Stephenson Cancer Center is Oklahoma's only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 73 NCI-Designated Cancer Centers in the United States. This highly competitive accreditation ensures that our patients receive the highest standard of care and have access to the most advanced cancer treatment options. At the Stephenson Cancer Center, we have an exciting new job opportunity that could be right for you! The IIT Research Program Coordinator will coordinate and administer multiple clinical research projects by performing clinical research, subject recruitment, budget preparation, data analysis, IRB coordination, training and site coordination within the Investigator-initiated Trial (IIT) Program. Learn more about the Stephenson Cancer Center's Clinical Trials Office here.

Requirements

Bachelor's degree in Nursing or Health Professions field, AND:
24 months experience in nursing, healthcare, or clinical trials management.
Equivalency/Substitution: Will accept 48 months of related experience in lieu of the Bachelor's degree for a total of 72 months of related experience.
Certifications or Licenses: If the department requires a RN or Physician Assistant, the applicant must have current state licensure.
Knowledge of project management

Responsibilities

Project Coordination. Coordinates the activities between clinical research projects within the IIT Program and between those projects and other programs on the national or state level.
Clinical Research. Works with academic and clinical staff to develop clinical research and training materials. May include clinical protocols, laboratory manuals, informed consent documents, and other study-related materials.
Document Management. Assists clinical investigators in planning, organizing, and delivering management of study documents. May include single-site clinical trials and/or multi-site clinical trial document management.
Subject Recruitment. Slot management for enrollment of research subjects for clinical research projects. Reviews medical histories and source documentation to determine eligibility. Assists in enrollment activities of subjects meeting criteria of the clinical trial at the site level.
Budget Preparation. Manages the budget for clinical research projects sponsored by outside funding sources, including evaluating potential budget impact of proposed clinical protocol changes.
Data Analysis. Organizes and participates in the analysis of collected data. May coordinate meetings at appropriate data analysis intervals and prepare data for regulatory submissions. Notifies data team of future database updates per protocol revisions, as appropriate.
IRB Coordination. Works with the University staff members, regulatory authorities, and participating site(s) to develop protocols and consent forms for research projects including human subjects. Ensures projects are in compliance with federal regulations. May submit protocols, progress reports, etc., to single Institutional Review Board(s).
Training. Provides training and education to the Stephenson Cancer Center staff, Faculty, and external sites' research staff concerning the research projects and IIT Program.
Site Coordination. Managing clinical trial timelines from concept to activation of site(s). Oversees clinical trial conduct. Conducts regular in-person or teleconference meetings with Principal Investigators and external sites. Resolve issues and determine issues to escalate to management as necessary. Ensure milestones are met as planned.
As Needed. Performs various duties as needed to successfully fulfill the function of the position.