Program Manager

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.

The UNC SOM Clinical Research Alliance (CRA) coordinates large multi-center trials generating evidence to advance treatments that serve North Carolinians and beyond. Working with the leading scientific experts at UNC in partnership with the National Institutes of Health and Pharma, and national academic institutions, the CRA provides full-service coordination through pre to post award activities.

Activities within the CRA include proposal management and submission, protocol and CRF development, IRB and FDA submissions, site training and certification, recruitment and enrollment, data capture and management, study monitoring and safety reporting, and study compliance and quality for large scale Phase II IND studies and more.

The Program Manager will serve to manage projects for large multi-institutional clinical trials. Responsibilities include cohesive efforts in planning, organizing, implementing, and managing study processes. This position will oversee day-to-day operations and coordination of projects, including facilitating meetings, coordinating study start-up activities, and tracking program progress. This position must be adaptive in nature, requiring a broad skill set and the ability to quickly address operational opportunities and weaknesses which may require interacting with multiple state and federal entities. In addition, this position ensures timely updates and formatting consistency to relevant reports and websites; compliance for quality assurance to include identifying, tracking, and reporting any barriers to hinder a successful outcome; deliverables for project protocols across various participating sites, vendors, and institutions are met; and all research is in adherence with the FDA Code of Federal Regulations, Good Clinical Practices, and IRB regulations for the protection of human subjects. Communication is critical as this position will manage communication with various levels of stakeholders to ensure accuracy and conclusively. This position will also work closely with senior leadership to determine necessary implementation and streamlined processes for expansion and operations.

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.

Experience starting up, managing, and closing multi-center trials.
Excellent written and oral communication skills, while continually demonstrating high levels of interpersonal versatility within diverse populations.
Strong interpersonal and organizational problem-solving skills.
Demonstrated ability to establish and maintain effective working relationships and credibility with coworkers, managers, and clients.
Ability to prioritize and manage competing tasks, including adeptness at time management.
Strong software and computer skills.
Must be a self- starter and comfortable with broad and varied responsibilities.
Ability to maintain confidential information with a high regard for integrity.
Maintaining organizational excellence will require advanced skills in coordination, communication, and an understanding of the interconnected relationships between internal and external entities.

Broad knowledge of clinical trial operations, FDA regulations with the ability to evaluate, prioritize and triage emergent and timely issues with little or no oversight.
Experience with UNC administrative systems and platforms that support clinical research.
Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) certification.
Bilingual (English, Spanish)

Not Applicable.