Clinical Research Manager

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

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 Clinical Research 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 Research 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; Two years clinical research experience; SOCRA/ACRP certification; 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

Five years of therapeutic clinical trial coordination experience involving drugs and/or devices, two of which should be in oncology;

One year of 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.

Special Instructions Quick Link https://unc.peopleadmin.com/postings/283141