Penn Medicine
Associate Director Oncology Research Operations
Penn Medicine, Plainsboro, New Jersey, us, 08536
Description
Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all disciplines.
Today at Penn Medicine, someone will make a breakthrough. Someone will heal a heart, deliver hopeful news, and give comfort and reassurance. Our employees shape our future each day. Are you living your life's work?
We are hiring for an Associate Director Oncology Research Operations to join our Cancer Services team at Penn Medicine Princeton Health. This role is a 5-year-grant-funded position that will extend into 2029, with the intention of seeking permanent and/or additional grant-funding past that date, as available. This individual must have oncology healthcare research expereince.
Summary:
The Associate Director Oncology Research Operations reports directly to the Director of Cancer Services at Penn Medicine Princeton Health. The Associate Director works closely with the Physician Leader of the Penn Medicine Princeton Health Oncology Research Team to oversee all aspects of the oncology clinical research portfolio. This employee will oversee the processes for study start-up and on-going study management from start to finish working closely with the CRU Regulatory coordinators to manage, review, and initiate trials to ensure competitive activation and enrollment timelines. The Associate Director is expected to actively manage ongoing research projects, troubleshoot operational issues on a daily basis and assist with any and all aspects of their team's work including, and not limited to, managing the research team protocol portfolio including budgets, patient visits, transporting specimens, data entry, query resolution, and working with study monitors. The Associate Director will also work closely with major internal (PI, Regulatory, Legal, Budget, Finance, Billing Compliance, Infusion, Pharmacy) and external (sponsors, facilities, CROs, Subcontractors, Collaborators) stakeholders to develop project plans and support day to day operations of clinical research proposals for their team. The Associate Director will work with Investigators and data informatics teams/programs to ensure the Research Program is supporting the patient population they are studying overseeing Phase I-IV of clinical trials. This employee may schedule patient visits and any necessary testing, monitor patients per protocol requirements, ensure adherence to protocol requirements, and organize and maintain all documentation required by the sponsor or CRO. This employee may collect, review and report study data, complete case report forms and resolve data queries, process and ship study specimens including blood, urine and tissue samples, participate in initiation, monitoring, audit and close-out visits, coordinate study team meetings, disease site and/or discipline group meetings, and ongoing protocol training/compliance meetings. The Associate Director will assist in the development/maintenance of study specific case report forms, source document tools, show vigilance in patient safety, protocol compliance and data quality. This employee must adhere to the requirements of the University of Pennsylvania, GCP, FDA and all applicable regulatory bodies.
Responsibilities:
SUPERVISION: Directly and/or indirectly supervising the clinical research nurse(s), clinical research coordinators(s), data manager(s) and research assistants for the team, including recruiting, interviewing, hiring, training, performance management, and paid time off for the staff. Conduct weekly or every other week meetings with team members to review the status of their studies in detail, items that are outstanding, and troubleshooting issues needing to be addressed. Ensure team meets regularly with PIs, manage biweekly PI team meeting with updates, education, discussion of new/active/ potential studies. Closely monitor and report to their team the status of all studies within their group, including accrual, data entry, query resolution, deviations and patient issues, identifying and addressing any issues.RESEARCH: Work with the research team physician investigator leader to ensure balanced staff workload, optimize study portfolio for currently available resources, anticipate any need for the research team to hire additional staff based on data analysis, maintain the overall staff assignments and workload for their group, identifying any needs or areas of underutilization. Develop and maintain relationships with potential and current pharmaceutical companies, internal and external collaborators in order to maintain pipeline of diverse studies that reflect PAH patient population. Work with physician leader, PIs, interdepartmental leaders and sponsors to facilitate the initiation of new trials from feasibility review, new study submission through activation, including tracking of protocols, contracts, and budgets through the start-up process, working with the sponsor to schedule SIVs, and maintain communication with study teams and collaborative UPHS departments regarding process. Ensure process moves steadily to completion, clear roadblocks to study start up.COMPLIANCE: Perform group-specific regulatory activities, such as site selection visits, document completion (site selection questionnaires, 1572s and financial disclosure forms), and IRB and IND report completion (with investigator input), including AE reports, deviations, CRs and modifications. Ensure staff education accompanies any deviations and AE reports. Work closely with central regulatory team to provide regulatory support for study team protocols by submitting complete Initial or Amendment study packets, performing site selection visits, regulatory document completion.BUDGETING: Work in conjunction with the ACC Budget Specialist, Billing Compliance staff, and Finance office to develop clinical trial budgets. Communicating any specialized study budget needs to the budget specialist, including any changes necessitated by a protocol modification and assisting the financial department by working with the study team to provide study visit information and invoiceable items as needed to the Finance Office. Maintain process to review quarterly revenue/expense forms with Abramson Cancer Center Budget Specialist and share information with PMPH leadership. Keep PMPH leadership informed of program finances.SYSTEMS: Work with team members to ensure accurate and timely data entry into electronic Clinical Trials Management System (Velos), including study status, screening logs, serious adverse events and subject enrollment status. The program manager may also have primary study coordinator responsibility for at least one study and may participate in specimen collection and processing as needed.COLLABORATION (Abramson Cancer Center & Penn Medicine Princeton Health): Review of program metrics (performance, portfolio, enrollment). Timely communication of significant challenges encountered by the team. Serve on subject matter expert work groups as needed to enhance overall workflow efficiencies and quality of research. Work closely with Penn Medicine Princeton Health interdepartmental leaders to develop and implement SOPs, report team study metrics, and communicate issues that may affect overall research goals. Continue to inform Abramson Cancer Center leadership of issues specific to community sites and need for potentially different processes or SOPs in community sites.
Credentials:
Education or Equivalent Experience:
Master of Arts or Science (Required)
Education Specialization: Healthcare or related field Equivalent Experience:
And 2+ year's Experience in a clinical research setting, master’s degree must be obtained or in progress
We believe that the best care for our patients starts with the best care for our employees. Our employee benefits programs help our employees get healthy and stay healthy. We offer a comprehensive compensation and benefits program that includes one of the finest prepaid tuition assistance programs in the region. Penn Medicine employees are actively engaged and committed to our mission. Together we will continue to make medical advances that help people live longer, healthier lives.
Live Your Life's Work
We are an Equal Opportunity and Affirmative Action employer. Candidates are considered for employment without regard to race, ethnicity, color, sex, sexual orientation, gender identity, religion, national origin, ancestry, age, disability, marital status, familial status, genetic information, domestic or sexual violence victim status, citizenship status, military status, status as a protected veteran or any other status protected by applicable law.
REQNUMBER: 238748
Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all disciplines.
Today at Penn Medicine, someone will make a breakthrough. Someone will heal a heart, deliver hopeful news, and give comfort and reassurance. Our employees shape our future each day. Are you living your life's work?
We are hiring for an Associate Director Oncology Research Operations to join our Cancer Services team at Penn Medicine Princeton Health. This role is a 5-year-grant-funded position that will extend into 2029, with the intention of seeking permanent and/or additional grant-funding past that date, as available. This individual must have oncology healthcare research expereince.
Summary:
The Associate Director Oncology Research Operations reports directly to the Director of Cancer Services at Penn Medicine Princeton Health. The Associate Director works closely with the Physician Leader of the Penn Medicine Princeton Health Oncology Research Team to oversee all aspects of the oncology clinical research portfolio. This employee will oversee the processes for study start-up and on-going study management from start to finish working closely with the CRU Regulatory coordinators to manage, review, and initiate trials to ensure competitive activation and enrollment timelines. The Associate Director is expected to actively manage ongoing research projects, troubleshoot operational issues on a daily basis and assist with any and all aspects of their team's work including, and not limited to, managing the research team protocol portfolio including budgets, patient visits, transporting specimens, data entry, query resolution, and working with study monitors. The Associate Director will also work closely with major internal (PI, Regulatory, Legal, Budget, Finance, Billing Compliance, Infusion, Pharmacy) and external (sponsors, facilities, CROs, Subcontractors, Collaborators) stakeholders to develop project plans and support day to day operations of clinical research proposals for their team. The Associate Director will work with Investigators and data informatics teams/programs to ensure the Research Program is supporting the patient population they are studying overseeing Phase I-IV of clinical trials. This employee may schedule patient visits and any necessary testing, monitor patients per protocol requirements, ensure adherence to protocol requirements, and organize and maintain all documentation required by the sponsor or CRO. This employee may collect, review and report study data, complete case report forms and resolve data queries, process and ship study specimens including blood, urine and tissue samples, participate in initiation, monitoring, audit and close-out visits, coordinate study team meetings, disease site and/or discipline group meetings, and ongoing protocol training/compliance meetings. The Associate Director will assist in the development/maintenance of study specific case report forms, source document tools, show vigilance in patient safety, protocol compliance and data quality. This employee must adhere to the requirements of the University of Pennsylvania, GCP, FDA and all applicable regulatory bodies.
Responsibilities:
SUPERVISION: Directly and/or indirectly supervising the clinical research nurse(s), clinical research coordinators(s), data manager(s) and research assistants for the team, including recruiting, interviewing, hiring, training, performance management, and paid time off for the staff. Conduct weekly or every other week meetings with team members to review the status of their studies in detail, items that are outstanding, and troubleshooting issues needing to be addressed. Ensure team meets regularly with PIs, manage biweekly PI team meeting with updates, education, discussion of new/active/ potential studies. Closely monitor and report to their team the status of all studies within their group, including accrual, data entry, query resolution, deviations and patient issues, identifying and addressing any issues.RESEARCH: Work with the research team physician investigator leader to ensure balanced staff workload, optimize study portfolio for currently available resources, anticipate any need for the research team to hire additional staff based on data analysis, maintain the overall staff assignments and workload for their group, identifying any needs or areas of underutilization. Develop and maintain relationships with potential and current pharmaceutical companies, internal and external collaborators in order to maintain pipeline of diverse studies that reflect PAH patient population. Work with physician leader, PIs, interdepartmental leaders and sponsors to facilitate the initiation of new trials from feasibility review, new study submission through activation, including tracking of protocols, contracts, and budgets through the start-up process, working with the sponsor to schedule SIVs, and maintain communication with study teams and collaborative UPHS departments regarding process. Ensure process moves steadily to completion, clear roadblocks to study start up.COMPLIANCE: Perform group-specific regulatory activities, such as site selection visits, document completion (site selection questionnaires, 1572s and financial disclosure forms), and IRB and IND report completion (with investigator input), including AE reports, deviations, CRs and modifications. Ensure staff education accompanies any deviations and AE reports. Work closely with central regulatory team to provide regulatory support for study team protocols by submitting complete Initial or Amendment study packets, performing site selection visits, regulatory document completion.BUDGETING: Work in conjunction with the ACC Budget Specialist, Billing Compliance staff, and Finance office to develop clinical trial budgets. Communicating any specialized study budget needs to the budget specialist, including any changes necessitated by a protocol modification and assisting the financial department by working with the study team to provide study visit information and invoiceable items as needed to the Finance Office. Maintain process to review quarterly revenue/expense forms with Abramson Cancer Center Budget Specialist and share information with PMPH leadership. Keep PMPH leadership informed of program finances.SYSTEMS: Work with team members to ensure accurate and timely data entry into electronic Clinical Trials Management System (Velos), including study status, screening logs, serious adverse events and subject enrollment status. The program manager may also have primary study coordinator responsibility for at least one study and may participate in specimen collection and processing as needed.COLLABORATION (Abramson Cancer Center & Penn Medicine Princeton Health): Review of program metrics (performance, portfolio, enrollment). Timely communication of significant challenges encountered by the team. Serve on subject matter expert work groups as needed to enhance overall workflow efficiencies and quality of research. Work closely with Penn Medicine Princeton Health interdepartmental leaders to develop and implement SOPs, report team study metrics, and communicate issues that may affect overall research goals. Continue to inform Abramson Cancer Center leadership of issues specific to community sites and need for potentially different processes or SOPs in community sites.
Credentials:
Education or Equivalent Experience:
Master of Arts or Science (Required)
Education Specialization: Healthcare or related field Equivalent Experience:
And 2+ year's Experience in a clinical research setting, master’s degree must be obtained or in progress
We believe that the best care for our patients starts with the best care for our employees. Our employee benefits programs help our employees get healthy and stay healthy. We offer a comprehensive compensation and benefits program that includes one of the finest prepaid tuition assistance programs in the region. Penn Medicine employees are actively engaged and committed to our mission. Together we will continue to make medical advances that help people live longer, healthier lives.
Live Your Life's Work
We are an Equal Opportunity and Affirmative Action employer. Candidates are considered for employment without regard to race, ethnicity, color, sex, sexual orientation, gender identity, religion, national origin, ancestry, age, disability, marital status, familial status, genetic information, domestic or sexual violence victim status, citizenship status, military status, status as a protected veteran or any other status protected by applicable law.
REQNUMBER: 238748