Director, NCCT Clinical Research Facilitation and Site Engagement

Job Description

JOB SUMMARY

The National Center for Clinical Trials (NCCT) is designed to serve as an innovative platform to revolutionize and catalyze the conduct of clinical trials-greatly accelerating the translation of scientific findings into improvements in the prevention, diagnosis, and treatment of disease for our communities and patients. The NCCT will offer core services for patient recruitment and enrollment, trial administration and follow-up, and to gather real world data and evidence.

The Clinical Trial Methods Center (CTMC) has been established within the Wake Forest University School of Medicine to provide the necessary tools and expertise that the NCCT will access and apply to deliver many of its core services.

This position will be primarily responsible for the navigation and facilitation of industry-sponsored clinical trials through the NCCT; as well as the identification, engagement, tracking and development of Advocate Health clinical sites that will participate in NCCT-designated trials. This includes leading all aspects of sponsor and internal feasibility, study activation, and the monitoring associated with study conduct and study closeout for each NCCT participating site.

Developing relationships with research and service line leaders across Advocate Health, Site Investigators and research site study staff, this position will help ensure the success of NCCT trials deployed across the Advocate Health footprint.

EDUCATION/EXPERIENCE

1. Master's degree in Business, Hospital, Public Health, Higher Education Administration, or a related field with ten years' experience in research, academic healthcare, and/or higher education management with successful track record of progressive responsibility required.
2. Demonstrated experience managing direct reports and completing performance management activities.
3. Demonstrated ability to work under pressure, meet deadlines, and process large amounts of information.
4. Demonstrated ability to communicate effectively with diverse clientele both verbally and in writing.
5. Demonstrated leadership, knowledge, and administrative experience with relevance to clinical research administration.

ESSENTIAL FUNCTIONS

1. Leads all personnel and processes related to site feasibility identification and assessment, as well as study start-up and study oversight for NCCT-designated clinical trials and Real-World Data Evidence (RWDE) studies with clinical components.
2. Establishes and maintains Advocate Health clinical site relationships with the NCCT. Identifies service line points of contact for each site targeted for trial activation.
3. Develop and catalogue the knowledge of each site's capabilities and past performance to assess their potential as NCCT-designated sites.
4. Works across functional areas to ensure the effective and efficient activation and conduct of each NCCT trial at each NCCT-designated site (e.g., Recruitment, Informatics, IT, Education, Central Trial Services Platform, and RWDE).
5. Works with NCCT leadership to finalize site management plans including PI identification/engagement and funds flow.
6. Ensures that all staff involved in the conduct of clinical trials at each site are trained in accordance with organizational policies and procedures.
7. Collects and reviews metrics to track Advocate Health site successes. Identifies trends and opportunities for process improvement in collaboration with the NCCT Evaluation Team.
8. Responsible for designing and implementing strategies that support the readiness of each NCCT-designated clinical site and uses data analytics to track and achieve site readiness goals.
9. Develops, implements and maintains strategic action plans that drive continued improvements in site activation and site conduct.
10. Performs other related duties incidental to the work described herein.

SKILLS/QUALIFICATIONS

• Experience in clinical research operations within an Academic Health System, Clinical Research Organization, Pharma/Biotech company.
• Experience in clinical research site management/oversight and site-level study conduct.
• Detailed understanding of all aspects of clinical study implementation and site monitoring.
• Strong collaboration, influence and communication skills to partner effectively with relevant stakeholders.
• Experience with managing clinical research study personnel.
• Highly developed organizational, problem solving and analytical skills, with the ability to prioritize time-sensitive tasks.
• Ability to work independently, make decisions and ensure project progress

WFUSOM-1

About Us

Wake Forest University School of Medicine (WFUSM) is a U.S. News and World Report top 50 ranked medical school, integrated with a world-class health system, Atrium Health. WFUSM, the academic core of Atrium Health Enterprise, is a recognized leader in experiential medical education and groundbreaking research that includes Wake Forest Innovations, a commercialization enterprise focused on advancing health care through new medical technologies and biomedical discovery. WFUSM, has over $300M in annual, extramural funding that drives a cutting-edge Academic Learning Health System by integrating innovative research with excellent patient care across our enterprise.

Atrium Health Wake Forest Baptist is based in Winston-Salem, North Carolina and is part of Advocate Health, which is headquartered in Charlotte, North Carolina, and is the fifth-largest nonprofit health system in the United States, created from the combination of Atrium Health and Advocate Aurora Health. AHWFB is an 885-bed tertiary-care hospital in Winston-Salem - that includes Brenner Children's Hospital, five community hospitals, more than 300 primary and specialty care locations and more than 2,700 physicians. Our highly integrated academic and clinical environment is deeply committed to improving health, elevating hope, and advancing healing - for all.

It should be noted that while you are applying on the Wake Forest University School of Medicine Career Site, you will receive communications from the Atrium Health Recruitment Team. Please know that this is an expected process. Thanks in advance for your flexibility.

About the Team

Mission, Vision and Culture Commitments

Mission

To improve health, elevate hope and advance healing - for all.

Vision

To be the first and best choice for care.

Culture Commitments

We create a space where all Belong

We Work as One to make great things happen

We earn Trust in all we do

We Innovate to better the now and create the future

We drive for Excellence - always