Department

LCCC - Clinical Trials-426806

Career Area

Research Professionals

Is this an internal only recruitment?

No

Posting Open Date

05/17/2023

Application Deadline

06/06/2023

Position Type

Permanent Staff (SHRA)

Position Title

Soc/Clin Research Manager - Advanced

Salary Grade Equivalent

GN17

Working Title

Research Regulatory Manager

Position Number

20055860

Vacancy ID

P017472

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

Full-Time Permanent

If time-limited, estimated duration of appointment

Hours per week

40

Work Schedule

Monday-Friday, 8:00 AM-5:00 PM

Flexible work arrangements, including virtual/hybrid work locations, are an integral part of the School of Medicine’s Working Forward initiative. As such, this position’s work location is designated as virtual. Please note that the designated work location is subject to change based on the unit’s business needs.

Work Location

Chapel Hill, NC

Position Location

North Carolina, US

Hiring Range

$82,785-$105,000

Pay Band Information

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

Primary Purpose of Organizational Unit

The UNC School of Medicine has a rich tradition of excellence and care. Our mission is to improve the health and wellbeing of North Carolinians, and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research. We strive to promote faculty, staff, and learner development in a diverse, respectful environment where our colleagues demonstrate professionalism, enhance learning, and create personal and professional sustainability. We optimize our partnership with the UNC Health System through close collaboration and commitment to service.
OUR VISION
Our vision is to be the nation’s leading public school of medicine. We are ranked 2nd in primary care education among all US schools of medicine and 5th among public peers in NIH research funding. Our Allied Health Department is home to five top-ranked divisions, and we are home to 18 top-ranked clinical and basic science departments in NIH research funding.
OUR MISSION
Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research.
Patient Care: We will promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond.
Education: We will prepare tomorrow’s health care professionals and biomedical researchers by facilitating learning within innovative curricula and team-oriented interprofessional education. We will cultivate outstanding teaching and research faculty, and we will recruit outstanding students and trainees from highly diverse backgrounds to create a socially responsible, highly skilled workforce.
Research: We will develop and support a rich array of outstanding health sciences research programs, centers, and resources. We will provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our University to support outstanding research. We will foster programs in the areas of basic, translational, mechanistic, and population research.

Position Summary

The Regulatory Manager is responsible for performance management of Clinical Protocol Office (CPO) Regulatory Staff. This supervisory role is comprised of staffing, work assignment, implementing the performance management program, supporting staff learning and development, leave management and schedules, and HR-related functions. This position is also responsible for the development and implementation of Regulatory Standard Operating Procedures. These responsibilities relate to the mission of the UNC/LCCC Protocol Office by addressing the regulatory compliance, thereby ensuring the quality of research and institutional integrity.

Minimum Education and Experience Requirements

Master’s degree in a discipline related to the field assigned; or Bachelor’s degree in a discipline related to the field assigned and two years of research/analysis, preferably with one year in a supervisory role; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

Required Qualifications, Competencies, and Experience

Knowledge of clinical research principles as defined by Code of Federal Regulations, Good Clinical Practices (GCP) and HIPAA regulations pertinent to research.
Knowledge of clinical research and human subjects’ protections methodology and technology.
Demonstrated ability to establish goals and objectives; plan and review the work of others and oversee work assignments.
Demonstrated ability to take a leadership role in implementing changes in design of clinical research management.
Demonstrated ability to problem-solve and resolve quality control issues by changing processes.
Demonstrated ability to lead, consult and make recommendations using effective oral and written communications.
Supervisory experience

Preferred Qualifications, Competencies, and Experience

CCRP, CCRC, CIRB or RAC Certification preferred.

Required Licenses/Certifications

Special Physical/Mental Requirements

Campus Security Authority Responsibilities

Not Applicable.

Position/Schedule Requirements