Project Manager II - National Center for Clinical Trials (NCCT) Education/Regulatory

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 part of a team that will report to leadership in the NCCT and will support multiple NCCT/CTMC Education & Regulatory initiatives.  With support from leaders, key responsibilities within areas of focus include management of Policies & Procedures, Education & Training, and Regulatory Systems Implementation. 

Policies & Procedures

• Supports the facilitation of the Clinical Trial SOP Committee meetings and working with stakeholders across the enterprise to align SOPs and associated guidelines.  
• Reviewing and editing existing SOPs and associated guidelines.
• Creating new SOPs and/or guidelines as new/revised regulations or policies dictate.
• Identifying and reconciling regional differences.
• Ensuring drafts are reviewed and approved by the standing SOP Committee and other stakeholders (e.g., IRB, Research Compliance, Privacy, IDS, etc.).
• Uploading finalized documents in centralized document management system.
• Communicate the availability of new and updated policies and procedures to the clinical research community.
• Working with Education Leaders to establish a plan/timeline to develop SOP training by research-related role.

Education & Training

• Collaborate with leadership to identify new user training needs and complete role-based template for user reference.
• Collect reports and document all completed trainings by learner.
• Collaborate with Clinical Translational Science Institute (CTSI) education team, as needed, to assign remedial training.
• Serve as a liaison between the SOP and CTSI education team to ensure alignment between SOPs and training content when updates are made.

Regulatory Systems Implementation

• Lead operational implementation of e-regulatory software solutions. 
• Serve as a liaison between vendor and stakeholders during the implementation.
• Facilitate the development of SOPs for e-regulatory software solutions including best practices, folder structures, standardized nomenclature of documents, permissions and roles (use legacy Midwest and Southeast Region SOPs as starting point). 
• Facilitate role-based training for new users to these systems.
• Manage software access requests to internal personnel and external monitors.
• Run reports to track usage.

EDUCATION/EXPERIENCE

Master's degree in Psychology, Nursing, or Basic Science with two years of relevant administrative and medical experience in research projects or other health-related activities; or, an equivalent combination of education and experience. One-year experience in a supervisory capacity. 

ESSENTIAL FUNCTIONS

• Facilitation: Ability to support the facilitation of meetings, particularly for the Clinical Trial SOP Committee.
• Document Management: Proficiency in reviewing, editing, and creating SOPs, guidelines, and guidance documents.
• Regulatory Knowledge: Understanding of regulations and policies to create new SOPs and guidance documents as needed.
• Collaboration: Ability to work with various stakeholders across the enterprise, including IRB, Research Compliance, and Privacy.
• Training and Education: Skills in conducting needs assessments, deploying education curriculum, and assigning user-specific training.
• System Implementation: Experience in leading the implementation of regulatory systems such as eBinders.
• Liaison Skills: Serving as a liaison between different teams and stakeholders during system implement