This position performs and coordinates all aspects of the clinical monitoring process at all clinical study sites (UNC and extended network) to assure and assess safety, efficacy of investigational products and/or medical devices, adherence to good Clinical Practices (GCPs), SOPs, and study protocols. Conducting and/or overseeing site visits to determine protocol and regulatory compliance, Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects working independently and in a team environment. May participate in the study development and start-up process including eCRF (Electronic Case Report Form) testing, developing study documents, organizing and presenting at investigator meetings, work with management on monitoring strategy, and/or developing project-specific CRA (Clinical Research Associate) Oncore training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. In addition to monitoring, responsibilities to include: Coordination of monitoring for entire LCCCIIT monitoring team; Oncore training for all network sites, including UNC. Working with the team to facilitate data collection for monitoring/audits.
Education and Experience:
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.
Knowledge of clinical research principles as defined by Code of Knowledge of clinical trial design; clinical research principles as defined by Code of Federal Regulations including Good Clinical Practices (GCP) 21 CFR Parts 50, 54, 56, 312, 314 along with ICH Guidelines and Health Insurance Portability and Accountability Act (HIPAA) regulations pertinent to research; clinical trials management and electronic data capture systems such as OnCore.
Demonstrated ability to plan and design data and information collection and technology.
Demonstrated ability to establish goals and objectives; plan and review the work of others and oversee work assignments.
Demonstrated ability to define standards for the collection of data and information; to set standards for accuracy, validity, and integrity; and to lead others in implementing these standards.
Demonstrated ability to lead, consult and make recommendations using effective oral and written communications.
Demonstrated ability to develop complete processes and procedures.
Oncology monitoring experience, SoCRA or ACRP certification desired.
The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.
Internal Number: 136635
About The University of North Carolina at Chapel Hill
Carolina rates among the nation’s great institutions of higher education, set on an historic and beautiful campus that celebrates all four seasons. Carolina’s students, faculty and staff come here from around the world, bringing varied cultural, racial and ethnic heritages that help make UNC-Chapel Hill a thriving intellectual center. We’re repeatedly ranked the nation’s best value in higher education for students seeking to earn a college degree – the University has garnered the top spot each time since the ranking’s launch in 1998.Whether you’ve just started your career, are new to academia or are a seasoned professional with assorted campus experiences to draw on, we hope you will find a great place at Carolina.