Senior Monitor

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 UNC Lineberger Comprehensive Cancer Center (LCCC) oversees and coordinates oncology clinical trial research for the UNC School of Medicine and UNC Cancer Care. The UNC LCCC Multicenter Clinical Trials Operations office is part of the UNC Lineberger Oncology Clinical Protocol Office (CPO). The UNC LCCC Multicenter office is responsible for overseeing compliance for the conduct of investigator-initiated (IITs) studies and cooperative group studies conducted at UNC-CH and UNC-LCCC studies conducted across the state of North Carolina (NC) and throughout the United States (US). This Senior Monitor position will be responsible for routine monitoring of all IITs at UNC LCCC, and also all IITs that are part of our multicenter efforts across NC and the US. This position is also responsible for routine monitoring all cooperative group studies that are part of the National Clinical Trials Network-Lead Academic Participating Sites (NCTN-LAPS) and ETCTN networks.

This position will ensure the validity, integrity, quality, and reproducibility of data collected; protection of rights and well-being of subjects and protocol compliance. All reviews will be conducted in accordance with GCP, FDA, protocol requirements, institutional policies and procedures and other applicable regulatory requirements.

Monitoring will follow a determined monitoring plan to ensure our institution meets DSMP guidelines. All studies will be conducted via study specific monitoring plans. The Senior Monitor participates in study activation preparation and is responsible for testing of CRFs, review of study protocols and study manuals, leading monitoring discussions during study initiation meetings.

The Senior Monitor will provide input on new procedures as it related to data entry/management. This position will work collaboratively with CDMA team and multicenter Project Manager to ensure data integrity. This position will also be responsible for training new staff and investigators across study sites on study and/or data related questions to ensure compliance throughout the execution of studies through close-out.

This position will be responsible to carry out single site IIT study close out.

This individual will also assist in training and orienting new team members.

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.

Required Qualifications, Competencies, and Experience

Must demonstrate in depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e. Good Clinical Practice (GCP), Food and Drug Administration (FDA) regulations and International Conference on Harmonization (ICH) guidelines.

Comfortable interacting with individuals at all levels internal and external to UNC Lineberger. Candidate must enjoy working collaboratively with multidisciplinary groups of colleagues. Excellent customer service skills and good judgement required.

Ability to multitask, and work independently with occasional guidance from supervisor. Strong organization and problem solving skills required. Must have a demonstrated ability to deliver high quality results on time and to manage competing priorities.

Must have clinical trials and/or monitoring experience.

Strong software and computer skills.

Preferred Qualifications, Competencies, and Experience

SOCRA or ACRP certification preferred

Special Physical/Mental Requirements Campus Security Authority Responsibilities

Not Applicable.

Special Instructions Quick Link https://unc.peopleadmin.com/postings/280073