Clinical Trials Manager PRMS

Required education and experience: Bachelors degree in health-related field to include Health Administration Public Health Nursing or closely related field AND:

• 48 months experience in clinical trials research coordination and/or administration professional level data management and analysis or other closely related professional role.

Equivalent/ Substitution:Will accept a total of 96 months of equivalent experience in lieu of a Bachelors degree.

Skills:

• Proficient in Microsoft Office

Certifications: None

Working Conditions:

• Physical:
  • Sitting for long periods of time.
  • Speaking and listening.
• Environmental:
  • Office Environment.

Department Preferences:Masters degree strong regulatory operations experience and experience with clinical trials/ research activities.

Why You Belong at the University of Oklahoma: The University of Oklahoma values our communitys unique talents perspectives and experiences. At OU we aspire to harness our innovation creativity and collaboration for the advancement of people everywhere. You Belong Here!

Equal Employment Opportunity Statement: The University in compliance with all applicable federal and state laws and regulations does not discriminate on the basis of race color national origin sex sexual orientation marital status genetic information gender identity/expression (consistent with applicable law) age (40 or older) religion disability political beliefs or status as a veteran in any of its policies practices or procedures. This includes but is not limited to admissions employment housing financial aid and educational services.

OU Health Stephenson Cancer Center is Oklahomas 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 Clinical Trials Manager - PRMS Provides senior administrative management to the clinical trials program by overseeing training and developing the Clinical Trials Office (CTO) Protocol Review & Monitoring Support (PRMS) Team. Provides professional-level support in evaluating business and operational practices to enhance the quality and delivery of services to the University. Supervises the CTO PRMS team ensures CTO processes follow NCI requirements as set forth by governing agencies develops strategies to raise awareness for PRMS processes stays abreast of new industry practices and acts as a liaison with other departments/organizations. Assists with preparation and production of the annual operating budget.

Learn more about the Stephenson Cancer Centers Clinical Trials Office here.

Duties:

• Program Management. Provides direct administrative and fiscal management for PRMS of the program(s) and related grants. Manages the day-to-day business operations of the program. Responsible for overseeing planning and monitoring of strategic plans. Manages and implements new workflows and processes to help improve collaboration within all CTO teams.
• Fiscal/Budget. Responsible for fiscal oversight and management to include decisions regarding appropriate rates within university approved salary ranges for new hires appropriate increases and promotions for existing staff and approval of purchases for the PRMS team such as supplies and equipment. Responsible for financial planning of the program(s) and monitoring progress. Develops and manages the PRMS teams budget. Ensures the fiscal viability of programs and advises college/department leadership on long-range financial planning and development of new initiatives.
• Assessment. Ensures staff correctly identifies clinical trial types and the initial assessment of appropriate start up activity to verify completeness that all applicable trial documents are provided and reviewed for each trial and each study is approved through all applicable SCC Committees prior to IRB submission. Responsible for conducting ongoing assessments of outreach and timelines to determine needed services funds and staffing.
• Information Distribution. Ensures clinic staff and other departments are made aware of new PRMS processes workflows and standards. Networking with other cancer institutions and applicable research partners to learn and share best practices and improve internal processes.
• Clinical Resource. Builds and maintains community relationships with outside physicians other health care organizations and serves as referral resource for non-CTO staff and investigators. Ensures completion of all SCC Committee related aspects of study start up continuing review and study close-out are complete from a PRMS perspective.
• Data Management. Manages clinical trials data and performs data analysis. Establishes and maintains reporting metrics and operational functions to leadership to help meet the institutional mission and objectives.
• Meeting Attendance. Attends and presents clinical trial and PRMS information at various meetings.
• Personnel Supervision. Supervises assigned staff to include hiring training scheduling workloads evaluating and terminating employees. Ensures all employees adhere to institutional policies and procedures while ensuring federal regulations are met.
• As Needed. Performs various duties as needed to successfully fulfill the function of the position.