Compliance Manager

Job description

Position Type:

Permanent Staff (SHRA)

Is this an internal only recruitment?:

No

Position Title:

Soc/Clin Research Specialist - Advanced

Working Title:

Compliance Manager

Position Number:

00051180

Vacancy ID:

P012589

Budgeted Hiring Range:

$65,544 - $85,000

Pay Band Information:

To learn more about the pay band for this branch and role, please see the Career Banding rates spreadsheet.

Salary Grade Equivalent:

GN14

Full-time/Part-time Permanent/Time-Limited:

Full-Time Permanent

Hours per week:

40

Work Schedule:

Monday – Friday; 8:00 a.m. – 5:00 p.m.

Department Name and Number:

LCCC - Clinical Trials-426806

Date First Posted:

04/12/2021

Closing Date:

04/19/2021

Position Location:

Chapel Hill, NC

Position Posting Category:

Research Professionals

Department Description:

The UNC Lineberger Comprehensive Cancer Center, founded in 1975, is a National Cancer Institute (NCI)-designated comprehensive cancer center. The Center’s mission is to reduce cancer occurrence and death in North Carolina and the nation through research, treatment, training, and outreach.

UNC Lineberger’s Clinical Protocol Office (CPO) is a centralized resource that supports the clinical research efforts of Lineberger investigators, primarily through the design and conduct of therapeutic clinical trials. The Protocol Office provides administrative, regulatory, data management, and study coordination services to investigators throughout the development, approval, and implementation processes of protocols conducted at UNC and its affiliate institutions. The Protocol Office is responsible for protecting the safety of patients participating in research, ensuring the quality of the research, and safeguarding the interests of the University. It also furnishes protocol-related information to health professionals and to the community at large.

Equal Opportunity Employer:

The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.

Position Description:

This position is responsible for developing the departmental infrastructure including the policies, procedures, training, and staff oversight to ensure that the unit meets its objectives and is adequately positioned to support an aggressive trajectory of growth over the next year. This position serves as Compliance Manager overseeing the creation of corrective and preventive action plans (CAPA) needed in the unit, liaising with the UNC Office of Clinical Research Quality Assurance to facilitate scheduling of the DSMP required audits of research conducted under LCCC’s data safety and monitoring plan, as well as working in tandem with the LCCC compliance committee chairperson. The individual must have a strong understanding of the NCI required Protocol Review Committee (PRC) and Data Safety and Monitoring Committee (DSMC). The major responsibilities of this position include serving as content expert for conducting Root Cause Analysis and CAPA creation, training faculty, staff, and outside institutions regarding matters of compliance, and informing/modifying policies and procedures as required institutionally or by national regulating bodies (i.e. NCI, FDA, and Office of Human Research Protections). This position will also lead process improvement initiatives within UNC Lineberger Clinical Protocol Office.

Minimum Education and Experience Requirements:

Bachelor’s degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

Essential Skills, Knowledge and Abilities:

Knowledge of NCI guidelines pertaining to PRC, DSMC, and Audit requirements for an NCI Designated Cancer Center
Demonstrated ability to follow established regulations, procedures, and protocols
Previous supervisory experience
Strong computer skills
Demonstrated ability to gather data and interpret trends
Demonstrated ability to follow, document, and/or author standard operating procedures
Demonstrated ability to lead, consult and make recommendations using effective oral and written communications
Demonstrated ability establish goals and objectives; plan and review the work of others and oversee work assignments
Able to problem-solve and resolve quality control issues by leading change in processes

Preferred Qualifications:

CCRP or CCRC Certification preferred. Oncology experience preferred. Previous experience in compliance related field preferred.

Position/Schedule Requirements:

Overtime occasionally

Stimulus/ARRA Funded:

No

 

 

 

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Job No:
Posted: 4/14/2021
Application Due: 4/21/2021
Work Type: Full Time
Salary: