National Center for Clinical Trials (NCCT) Regional Site Resource Manager

Department:

85296 Wake Forest University Health Sciences - WF Clinical Trial Methods Center of Excellence

Status:

Full time

Benefits Eligible:

Yes

Hours Per Week:

40

Schedule Details/Additional Information:

Regular Daytime Hours; Requires travel to regional sites

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 assessing and reviewing clinical trial sites across a region to ensure general readiness to conduct clinical trials and readiness to conduct specific clinical trials as they are presented. These responsibilities include evaluating and facilitating the development of site expertise and engagement, space to conduct trials, staff training, technology platforms and access, services available at sites to support trials, performance in conducting trials, etc. This position will also be responsible for working with NCCT and site leadership to develop capacity at sites through personnel and equipment purchases as necessary. In addition, this position will be responsible for assessing site readiness to conduct specific trials as needed. This position will work with business development and study coordination teams to streamline communications between all functional groups and facilitate research.

The role also involves coordinating with site leadership and research staff to address any issues that may arise and providing ongoing support to maintain the highest standards of trial conduct. Effective communication and collaboration with various stakeholders are essential to ensure the successful execution of clinical trials.

This position is a hybrid position that requires frequent travel to sites across a specific region (either 1) Wisconsin and Illinois, or 2) North Carolina, South Carolina and Georgia) for evaluation, assessment and relationship building.

EDUCATION/EXPERIENCE

Master's degree in a relevant discipline such as Health Administration, Nursing, Business, or Basic Science with three years of relevant management experience; or, an equivalent combination of education and experience. Significant experience in managing clinical trial teams at a service line, therapeutic area or at a site level.

ESSENTIAL FUNCTIONS

I. General Site Readiness Assessment

• Develops and maintains site readiness checklists and SOPs
• Tracks and reports site gaps
• Primary points of research-related contact for each site/service line/therapeutic area.
• Staffing levels and roles (e.g., PI, Sub-Is, CRCs, regulatory coordinators, lab techs, pharmacists)
• PI trial experience, expertise and enrollment performance
• Experience and training of site personnel related to NCCT SOPs (Including gaps in staffing, training, or certifications.)
• Facilities and space to conduct and monitor trials
  • Conduct physical walk-throughs of clinical space (exam rooms, infusion chairs, storage areas, etc.) and ancillary service areas.
• Equipment & Storage (including calibration processes and maintenance logs, alarms, etc.)
• Ancillary Services Capabilities
  • Pharmacy, lab, imaging, etc. (including site-specific SOPs for scheduling, procurement, storage tracking, etc.)
  • Diagnostic Services
• Technology Assessment
  • Confirm access to technology platforms (eg, EHR, EDC, etc.)

II. Per-Trial Readiness Assessment

• Work with site leadership and NCCT Central Trial Services Platform (CTSP) staff to assess site capability for protocol requirements.
• Investigator & St