**Primary City/State:**
Gilbert, Arizona
**Department Name:**
Admin-Rsrch
**Work Shift:**
Day
**Job Category:**
Research
Leadership careers are better at Banner Health. We are committed to developing the careers of our team members. We care about you, your career today and your future. If you’re looking to leverage your abilities – apply today.
**This is a full-time position, scheduled Monday through Friday, 8am to 5pm.** This is a remote position; minimal travel is required monthly to BMDACC locations as well as BAI and BSHRI.
This position will be responsible for overseeing all aspects of the clinical trial start-up process, including regulatory submissions, budget negotiations, and site selection across Banner Research. Ensures all clinical trial activities comply with local, national, and international regulatory standards. Leads and manages the feasibility and start-up teams, providing training, guidance, and oversight. Oversees the financial aspects of clinical trial start-up, including budgeting, resource allocation, and financial reporting. Acts as a key point of communication between research sites and departments, and the senior leadership team, providing regular updates on performance metrics and operational insights.
Your pay and benefits are important components of your journey at Banner Health. This opportunity includes the option to participate in a variety of health, financial, and security benefits. In addition, this position may be eligible for our Management Incentive Program as part of your Total Rewards package.
Banner Research is at the leading edge in a new era of scientific discovery and innovation. Our basic and clinical research faculty turns ground-breaking research findings into new identification, treatment and prevention methods for diseases such as Alzheimer's, Parkinson's, Cardiovascular disease, Cancer and Orthopedics. We have an international reputation for our work and we provide outstanding access for patients to clinical trials. Our commitment to excellence allow us to make a difference in people's lives every day.
POSITION SUMMARY
This position provides consistent leadership and general oversight of the daily administrative activities of the startup and feasibility teams responsible for the clinical trial portfolios managed within Banner Research. Will support research operations strategic priorities to enhance interdepartmental communication and collaboration. Leads the development of best practices and tools for protocol execution, management and oversight in the feasibility and startup process. Ensures strong communication with internal and external parties along with regulatory compliance. This position has a significant impact on the ability to effectively implement quality and efficient feasibility and startup processes for clinical studies and develop the pipeline and by developing teams to consistently meet and exceed standards.
CORE FUNCTIONS
1. Feasibility Assessment: Leads the system-wide comprehensive feasibility assessments and start-up processes for new clinical trials, evaluating site capabilities, patient populations, and logistical considerations. Collaborates with investigators, clinical teams, regulatory, finance and legal to determine the feasibility and value of proposed clinical trials. Utilizes data and metrics to analyze and select appropriate trials for the organization. Develops long-term vision and strategy for feasibility and start-up practices across the organization.
2. Study Start-Up: Oversees all aspects of the clinical trial start-up process, including regulatory submissions, budget negotiations, and site selection. Ensures timely execution of Confidentiality Disclosure Agreements (CDAs) and Clinical Trial Agreements (CTAs). Coordinates with ancillary departments to develop study processes and ensure protocol adherence.
3. Regulatory & Cybersecurity Compliance: Ensures all clinical trial activities comply with local, national, and international regulatory standards. Maintains strong communication with regulatory and IT cybersecurity teams and ensures timely submission of required documents and approvals received.
4. Team Leadership: Leads and manages the feasibility and start-up teams, providing training, guidance, and oversight. Fosters a collaborative environment to enhance interdepartmental communication and teamwork. Provides ongoing training and development opportunities for the feasibility and start-up teams.
5. Stakeholder Collaboration: Builds and maintains relationships with investigators, sponsors, and external partners. Promotes the organization's reputation and ensures strong communication with all parties involved in the clinical trials.
6. Budget Management: Oversee the financial aspects of clinical trial start-up, including budgeting, resource allocation, and financial reporting. Collaborate with finance teams to ensure accurate and efficient budget management.
7. Protocol Development: Assists in supporting the development and optimization of clinical trial protocols to support investigator-initiated study outcome goals. Ensures all study documents, including informed consent forms, are accurately created and maintained.
8. Vendor Management: Leads efforts to establish service agreement contracts with outside vendors in support of research efforts and activity across all departments.
9. Communication and Reporting: Acts as a key point of communication between research sites and departments, and the senior leadership team, providing regular updates on performance metrics and operational insights.
MINIMUM QUALIFICATIONS
Knowledge typically obtained through completion of a Bachelor’s degree in Biology, Nursing, Business, Medical, Science or related field.
10 years of related research or healthcare experience with 5 or more years in supervisory/managerial level experience is required.
Broad knowledge of all phases of clinical research, from study startup through closeout. Knowledgeable about clinical studies involving complex trial design issues. Experience in Oncology, Alzheimer's Disease, Cardiovascular research.
Experience working with NIH/NIA and other federal grant funding agencies.
PREFERRED QUALIFICATIONS
RN or Master's degree in a related area; or equivalent combination of experience and training.
Regulatory knowledge of clinical research conduct and health care operations is strongly preferred.
Advanced experience in project management, including ability to multi-task and re-prioritize deliverables as necessary to meet tight timelines.
Additional related education and/or experience preferred.
**EEO Statement:**
EEO/Disabled/Veterans (https://www.bannerhealth.com/careers/eeo)
Our organization supports a drug-free work environment.
**Privacy Policy:**
Privacy Policy (https://www.bannerhealth.com/about/legal-notices/privacy)
EOE/Female/Minority/Disability/Veterans
Banner Health supports a drug-free work environment.
Banner Health complies with applicable federal and state laws and does not discriminate based on race, color, national origin, religion, sex, sexual orientation, gender identity or expression, age, or disability