NCTN PROGRAM MANAGER
Duties: The Penn National Cancer Trial Network- Program Manager reviews proposals to open new NCTN studies from center investigators and discusses portfolio strategies with sub-unit leaders and the NCTN PI to ensure the ACC goals for the NCTN program are being met; confirms Principal Investigator involvement with the Penn NCTN PI and/or registers new PIs with the NCTN; writes Standard Operating Procedures and Manuals of Procedures for the conduct of research under the Penn NCTN umbrella and ensures all investigators and staff understand the SOP/MOP via hand-on training, mentoring and providing operations support during all phases of study opening, conduct and closing; provides training on the conduct of cooperative group research vs. industry or locally sponsored research; confirms affiliates and takes action to add/remove affiliate institutions as appropriate to build a high quality and compliant affiliate structure; receives all alerts, announcements and newsletters from all NTCN sponsors and disseminates the information to all users and ensures site compliance with such alerts via conference calls, meetings and training; reviews data compliance (outstanding data, queries, data lateness) reports on a monthly basis for all NCTN studies in the center and takes appropriate actions based on the MOP to ensure issues are address timely and completely; evaluates data expectancy reports on a monthly basis and takes appropriate actions locally and with affiliates to address issues; participates in all aspects of monitoring and auditing preparation and manages site inspections performed by the NCI/Theradex and or the NCTN programs (i.e. ECOG, SWOG, etc.); works with study teams to make sure all issues identified during monitoring or audits are addressed in a timely manner to avoid major compliance issues and uses the outcome of monitoring/auditing to evaluate the effectiveness of MOPs, training and operations and makes adjustments as necessary to improve quality, compliance, efficiency and overall performance of all disease groups participating in Penn NCTN research. Additionally the NCTN Program Manager will assist protocol teams with all aspect of startup as needed, including submissions to IRBs and ancillary review committees, addressing review body concerns that impede study start-up, planning and conducting study in-service training for all new protocols; evaluating other logistics and budgets as needed and will assist with evaluation of and coordination of distribution of funds when they become available. The NCTN Program Manager must create a centralized and harmonized infrastructure to support research across the various Penn Departments and Division involved in the conduct of NCTN research and be able to work within the existing infrastructure of each unit that currently supports NCTN center-wide. The NCTN Program Manager will be responsible for implementation of technology to facilitate performance reporting on the NCTN portfolio to the Penn NCTN PI and Sub-Unit leaders.
Qualifications: The ideal candidate will have the minimum of a Bachelor's degree and 5-7 years experience in the conduct and operations of clinical research. Advanced degree preferred Experience with NCI cooperative group research and experience as a manger are strong pluses. The appropriate candidate for this position will have a working knowledge of clinical research conduct, operations, and quality control as well as the ability to work across diverse teams. Candidate must have outstanding time management skills, be flexible, be detail and goal oriented, be self-motivated and able to work in a high pressure environment under strict deadlines. Candidate must be facile with technology and have the skills necessary to develop reporting infrastructure.
Reference Number: 40-26641
Salary Grade: 028
Employment Type: Exempt
Org: CC-Cancer Center
Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Job Family: I-Technical/Professional Research