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Department: 480502 - HR UTS/UNC Partnership
Essential Job Duties:
Project Manager in charge of representing the department on a national level. Candidate must have project management, training, grant management, audit preparation and CAPA development, as well as site administrative skills.
The selected candidate will be responsible for ensuring the validity, integrity, quality and reproducibility of data collected for clinical research studies. The role serves as a Project Manager supporting UNC compliance and providing subject matter expertise for each of the National Clinical Trials Network (NCTN) groups and associated systems, to include: Cancer Trials Support Unit (CTSU), Alliance, NRG, SWOG, and ECOG-ACRIN, This position serves as Lead Clinical Research Professional, and is the point of contact for all NCTN Affiliate Sites; provides oversight of all National Group memberships and study participation; attends national conferences, and participates in training/retraining activities.
Additionally, this position facilitates and responds to all NCTN and Experimental Therapeutics Clinical Trials Network (ETCTN) audits. This involves assessing the evaluation, collection, and submission of research data for completeness, compliance, and accuracy. The Cooperative and National Group Coordinator communicates findings with UNC PIs, CPO management, CPO study staff, and Affiliate study staff as appropriate, creates reports of findings, and ensures the completion of corrective action plans for any deficiencies.
Serve as liaison between UNC and the NCI and national groups. Including transmitting information to the appropriate staff, responding to questions, and facilitating problem resolution. Maintaining roster/membership for UNC and affiliates. Facilitate cooperative group audits for UNC and our affiliates. Manage timelines and coordination of audits.Interface with pharmacy, clinical and regulatory staff to ensure coordination. Conduct mock audits as quality assurance and as audit preparation. Serve as subject expert for all cooperative groups and NCI grants. Participate in conference calls and training activities. Attend occasional national and local off-site meetings as well as regular meetings with UNC staff and investigators. Train employees on the processes required of each group. Train and document training of new employees on cooperative group trials. Identify user needs and provide re-training as needed.Maintain expertise of NCI grant requirements and the UNC department compliance with all applicable requirements and application deadlines. Assists with grant renewals or applications as necessary.
This position requires experience in oncology and full knowledge of clinical research principles as defined by Code of Federal Regulations, Good Clinical Practice (GCP) Parts 50, 54, 56, 312, 314 and ICH Guidelines. This knowledge enables the Cooperative Group Project Manager to oversee compliance, guidance and training of staff members (CPO, non-CPO, affiliate institutions), and to establish professional relationships with sponsors and investigators. The Cooperative Group Project Manager must be able to communicate with authority based in their professional knowledge. Knowledge of information technology is also required to analyze and report data/information from Oncore and training of staff. This position requires the ability to evaluate and modify resources to process work against competing timelines and the ability to provide consultation regarding the use of information available in the Oncore database. These abilities are necessary for consulting with UNC and affiliate sites for cooperative group and NCI related guidance and for study initiation and maintenance.
This position requires the ability to plan work to meet objectives and deadlines, lead multiple concurrent assignments, follow established guidelines for assessing compliance through auditing and monitoring, and the ability to suggest possible ways to improve the processes. These abilities are essential for providing guidance to staff (CPO, non-CPO, affiliate institutions) regarding Cooperative Group and NCI studies. This position requires the ability to write comprehensive reports and the ability to convey major points to other staff and supervisory personnel. These abilities are essential to providing guidance and to interacting with others in the management and oversight of clinical research, including communications with the Food and Drug Administration and the Institutional Review Board.
This position requires the ability to monitor and collect data and information as required by CPO procedures as well as the ability to input that data and information into the OnCore database. This competency is required to analyze data/information for accuracy, validity and integrity and to apply criteria for extraction of data/information for reports with appropriate information based on audience: PIs, study staff, audit committee and DSMC.
This position also requires the ability to perform simple statistical analyses and to observe and report trends in data or information in order to prepare comprehensive reports. This position requires the ability to lead exchange of information through technical assistance and instruction in the area of cooperative group and NCI studies, including the ability to prepare and present reports This position also requires the ability to independently provide consultation to investigators, UNC and affiliate staff, and sponsors related to cooperative groups and NCI study knowledge in general and specific clinical trials.
Computer skills. Knowledge of medical terminology or willingness to learn this body of knowledge is essential.
Experience working in clinical research including audit and/or data management.
Prior experience in data extraction. Accuracy and attention to detail. Excellent written and verbal communication skills. Clinical research experience. ACRP or SoCRA certification. Prior experience with Cooperative Group or NCI trials.
ONCOLOGYEXPERIENCE IS REQUIRED.
Required license or certification:
Position Number: 48AJ83
NC State University is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, gender identity, age, sexual orientation, genetic information, status as an individual with a disability, or status as a protected veteran.
If you have general questions about the application process, you may contact Human Resources at (919) 515-2135 or email@example.com. Individuals with disabilities requiring disability-related accommodations in the application and interview process, please call 919-515-3148.
Final candidates are subject to criminal & sex offender background checks. Some vacancies also require credit or motor vehicle checks. If highest degree is from an institution outside of the U.S., final candidates are required to have their degree equivalency verified at www.wes.org or equivalent service. Degree(s) must be obtained prior to start date in order to meet qualifications and receive credit.
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