National Center Clinical Trials; NCCT Clinical Trial Facilitation Manager

Department: 85296 Wake Forest University Health Sciences – Clinical Trial Methods Center of Excellence

Status:
Full time

Benefits Eligible:
Yes

Hours Per Week: 40

Schedule Details/Additional Information:
Regular

Pay Range: $43.30 – $64.95

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 part of a team that will report to leadership in the NCCT and will provide overall management of the operational team and will provide study oversight project management for specific trials as needed.

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.

This position will serve as a working manager who manages:
Study Start-Up Navigators (SSUNs), Study Feasibility Project Managers (SFPMs) and Study Oversight Project Managers (SOPMs); and will also provide study oversight project management for specific trials as needed.

I. Manager over Study Start-Up Navigators, Study Feasibility Project Managers and Study Oversight Project Managers who perform the following activities:

Trial Navigation: SSUNs serve as central point of contact for sponsors and study teams from first contact through trial activation, gather necessary information from sponsors and functional areas for trial feasibility assessments and trial activation, initiate trials in research systems, provide information to regulatory, budgeting, and contracting teams for rapid trial start-up.

Trial Feasibility Analyses: SFPMs work closely with local study teams, ancillary service providers and with informatics, recruitment and IT functional areas to render informed decisions as to whether the AHNCCT should take on specific trials.

Study Oversight Services: SOPMs serve as central points of contact for sponsors and study teams from trial activation through trial closeout. SOPMs facilitate set up of trials and can provide oversight of multisite trials, link local study teams to recruitment, informatics, budget/contracting, regulatory and IT teams. In addition, they can deploy 3rd party clinical trial coordinators to back up local study teams as needed.

II. Study Oversight Project Management

Study Oversight Manager helps to set up, monitor and manages the overall progress of trials.

• Facilitates set up of trials at sites
• Facilitates and attends site initiation visits.
• Responsible for outreach to applicable physicians, care teams, etc to gain valuable information.
• Maintain working knowledge of clinical trials within research portfolio.
• Connects study staff members with training resources as necessary for compliance with policies.
• Monitors progress of the clinical trial until completion ensuring accrual, study activities and quality measures are met.
• Mitigates issues as they arise (e.g., difficulty meeting enrollment targets, etc.)
• Liaises with regulatory to monitor amendments, personnel changes, etc.
• Liaises with sponsor, investigator(s) and site staff throughout trial.
• Monitors resource demands throughout trial.
• Supports the deployment of coordinators and Advanced Care Providers to sites as needed for study conduct.

III. Performs other related duties incidental to the work described herein.

Excellent verbal and written communication skills. Ability to work independently to…