Associate Operations Project Manager - Regulatory

Job Description

Description

Become part of an inclusive organization with over 40,000 diverse employees, whose mission is to improve the health and well-being of the unique communities we serve.

Summary:
Leads and collaborates on research regulatory project development from beginning to end and ensures completion successfully within the given deadline and budget. Follows through on pre-defined regulatory project scope, goals, and deliverables that support business goals and organizational mission. Assists with the conduct and development of full-scale regulatory project plans, project tools, Conflict of Interest, quality assurance follow ups, regulatory audits, IRB submissions and associated IRB communications documents. The individual selected for this position will be responsible for the coordination, implementation, execution, and completion of multiple, simultaneous research regulatory projects ensuring consistency with UNC Health strategy, mission and goals.

Responsibilities:
 1. Assists with the development of regulatory project plans, goals, and deliverables. Identifies resources needed and develops schedules while maintaining optimum working relationships with all departmental units. 

2. Assists with the preparation and dissemination of research regulatory project communications. Communicates with project sponsors and functional area managers/directors regarding status of specific regulatory projects. Produces regulatory project reports as required. 

3. Collaborates on all phases of the regulatory projects to achieve schedule, cost and performance objectives, while maintaining the scope of the projects. 

4. Coordinates effort and manages relationships with vendors and contractors necessary for any regulatory projects. 

5. Performs analysis for the regulatory projects and develops objective means or status reports for assessing the status of the regulatory projects that are consistent with standard skills of project managers. 

6. Prepares requests for regulatory quality audits or reviews and conducts all necessary meetings to facilitate selection of regulatory project services and products. Assists regulatory project team members and monitors regulatory project performance. 

7. Responsible for research regulatory program and project assignments working independently or collaboratively as appropriate to accomplish the assigned work. Identifies issues and assists in developing strategies to address them prior to issues becoming critical. Keeps management informed of regulatory project(s) status and any potential issues. 

8. Serves as the lead regulatory contact for internal and external support and training. 

Other Information

Other information:
Education Requirements:

• Bachelor’s degree in applicable field

•  CCRA, CCRC, CCRP, CHRC or CIP preferred
  

Professional Experience Requirements:
● One (1) year of professional experience in research-related regulatory project management or lead/senior level regulatory program administration. Prior experience in E-regulatory, regulatory study start-up, IRB submissions and approvals, conflict of Interest review, quality improvement, regulatory audit prep, strategic planning, or risk management preferred.
● If Master's degree in Business Administration or Health Administration, no experience is required.
● If Associate's degree,  five (5) years of professional experience in project management or program administration.
● If High School, nine (9) years of professional experience in project management or program administration.

Knowledge/Skills/and Abilities Requirements:

• Strong knowledge of regulatory project management techniques and tools. 
• Familiarity with governmental regulations and guidance documents related to research. 
• Ability to write reports, professional correspondences and procedure manuals. 
• Effectively present information and respond to questions from groups of managers, clients, customers and general public. 
• Ability to work effectively in Microsoft Office 365 applications and virtual communication platforms. 

Job Details

Legal Employer: NCHEALTH

Entity: Shared Services

Organization Unit: Research Compliance 

Work Type: Full Time

Standard Hours Per Week: 40.00

Work Schedule: Day Job

Location of Job: US:NC:Chapel Hill

Exempt From Overtime: Exempt: Yes