*Clinical Trials Manager - Tissue Lab

Job Description

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 Clinical Trials Manager in the Clinical Trials Office Tissue Lab provides senior administrative management to the clinical trials program for the Tissue Lab by overseeing all aspects of the lab's operations, including but not limited to ensuring appropriate laboratory requirements and safety regulations are met, assisting in negotiating contracts with sponsoring funding agencies, preparing and submitting applicable regulatory filings, planning and controlling the budget, supervising the clinical trials Tissue Lab staff, engaging in marketing communications and strategies to raise revenues and awareness for programs, and acting as a liaison with other departments/organizations.

Learn more about the Stephenson Cancer Center's Clinical Trials Office here.

Responsibilities:

• Provides direct administrative oversite of laboratory-based clinical research operations, including fiscal management of associated grant -funded and industry-sponsored programs. Manages the day-to-day business operations of the laboratory and clinical trial operations in accordance with institutional guidelines, protocol requirements, and Good Clinical Practice (GCP) standards.
• Responsible for overseeing strategic planning initiatives related to laboratory program growth, protocol expansion and operational sustainability. Monitors implementation timelines, evaluates progress and adjusts strategies accordingly.
• Responsible for fiscal oversight and management to include negotiating service contracts and purchasing of supplies and equipment for Clinical Trials program. Responsible for financial planning of the program(s) and monitoring progress.
• Develops and manages the program(s) budget. Ensures the fiscal viability of programs and advises medical and college/department leadership on long-range financial planning and development of new initiatives.
• Develops detailed budgets for grant submissions in collaboration with investigators and administrative offices. Ensures compliance with sponsor - specific budgetary guidelines and institutional policies.
• Ensures staff correctly identifies patients who may be eligible to participate in the clinical trial. Confirms documentation of clinical history, laboratory results, eligibility checklists and informed consent are completed per protocol.
• Responsible for conducting ongoing assessments of outreach and recruitment strategy to determine needed services, funds, and volunteers.
• Ensures potential patients receive IRB approved study information from clinic staff. Establishes and maintains community relationships with outside physicians, External providers of other health care organizations, and serves as referral resource for study participants.
• Completes all aspects of study start up processes including site qualification, IRB submissions, laboratory readiness and investigator SIV participation
• Manages clinical trials data acquisitions and performs data analysis workflows. Attends and presents clinical trial information at various meetings
• Supervises assigned staff to include hiring, training, scheduling workloads, evaluating, and terminating employees.
• Ensures all employees adhere to protocol specific procedures, institutional SOP's and federal research regulations
• Performs various duties as needed to successfully fulfill the function of the position in addition to ensuring uninterrupted research operations and regulatory compliance.

Job Requirements

Required Education: Bachelor's degree in health-related fields to include Health Administration, Public Health, Nursing, or closely related field.

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

Certifications/Licenses: none

Working Conditions:

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

Skills:

• Proficient in Microsoft Office

Department Preferences: Certified Clinical Research Professional (CCRP) certification. Lab experience and/or management.

Why You Belong at the University of Oklahoma: The University of Oklahoma values our community's 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.