Job Information
University of North Carolina- Chapel Hill Senior Monitor in NC-Chapel-Hill, United States
Employment Type: Permanent Staff (EHRA NF)
Vacancy ID: NF0008119
Position Summary/Description:
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.
Education and Experience:
SOCRA or ACRP certification preferred
AA/EEO Statement:
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, national origin, race, religion, sex, sexual orientation, or status as a protected veteran.