The UNC Lineberger Comprehensive Cancer Center, founded in 1975, is one of only 51 National Cancer Institute (NCI)-designated comprehensive cancer centers in the country. The Center’s mission is to reduce cancer occurrence and death in North Carolina and the nation through research, treatment, training and outreach.
UNC Lineberger’s Clinical Protocol Office is a centralized resource that supports the clinical research efforts of Lineberger investigators, primarily through the design and conduct of therapeutic clinical trials. The Protocol Office provides administrative, regulatory, data management, and study coordination services to investigators throughout the development, approval and implementation processes of protocols conducted at UNC and its affiliate institutions. The Protocol Office is responsible for protecting the safety of patients participating in research, ensuring the quality of the research, and safeguarding the interests of the University. It also furnishes protocol-related information to health professionals and to the community at large.
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:
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.
Essential Skills, Knowledge and Abilities:
Advanced knowledge of ICH GCP, Federal Regulations and Guidelines and ability to follow established regulations, procedures, and protocols; 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.
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.
Lineberger Comprehensive Cancer Center’s Clinical Protocol Office is recruiting for 4 Social/Clinical Research Specialist (Clinical Research Manager) positions – 00052020, 20001052, 20010901, and 20012437. By applying to this posting you will be considered for all four positions.
Posting Close Date: 02/25/2021