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A global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation’s top public universities. Known for its beautiful campus, world-class medical care, commitment to the arts and top athletic programs, Carolina is an ideal place to teach, work and learn.
One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community.
University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events. UNC-Chapel Hill offers full-time employees a comprehensive benefits package, paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance.
Primary Purpose of Organizational Unit
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 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 prepare tomorrow`s healthcare professionals and biomedical researchers from all backgrounds by facilitating learning within innovative and integrated curricula and team-oriented interprofessional education to ensure a highly skilled workforce.
Research: We develop and support a rich array of outstanding health sciences research programs, centers and resources. We provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our university to support outstanding research. We foster programs in the areas of basic, translational, mechanistic and population research.
Position Summary
The Clinical Operations Manager provides oversight and management of a large number of clinical research staff to ensure safe, compliant, efficient, and effective conduct of oncology clinical trials. This position provides expert level knowledge in clinical trial practices and regulations. This position works under the direct supervision of the Assistant Director of Clinical Research Operations to ensure safe implementation of oncology clinical trials. The Clinical Operations Manager manages clinical research staff assigned to various disease teams within the Clinical Protocol Office (CPO) providing daily management/supervision, resource and effort allocation, overseeing research compliance and data integrity, and assisting in strategic planning and operational support. This position creates and champions a collaborative and positive relationship dynamic with internal staff and external agencies/organizations.
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
Advanced knowledge of ICH GCP, Federal Regulations and Guidelines and ability to follow established regulations, procedures, and protocols; clinical research experience; Experience in interviewing/hiring process and performance management; Possess strong decision-making skills and the ability to problem solve and troubleshoot issues; Strong organizational skills with the ability to manage large volumes of information; High level of accuracy and attention to detail; High level of comfort with technology; Strong computer skills; Ability to gather data and document procedures; Ability to plan work and coordinate multiple projects; Ability to contribute to preparation and delivery of reports, trainings and SOPs; Customer oriented and ability to work within, build and lead a team; Exceptional interpersonal skills and excellent verbal and written communication skills in daily interactions with the ability to interpret and apply UNC policies and federal, state, and local regulations; Ability to work on evenings, weekends and/or holidays occasionally required.
Preferred Qualifications, Competencies, and Experience
Therapeutic clinical trial coordination experience involving drugs and/or devices, to include work in oncology;
SOCRA/ACRP certification;
Supervisory experience;
Experience in Phase I, II, and III clinical research;
Experience navigating medical records and data extraction;
Experience leading a large team.
Special Physical/Mental Requirements
Campus Security Authority Responsibilities
Not Applicable.
