"Project Manager, Breast Cancer Clinical Research"

Project Manager, Breast Cancer Clinical Research

Job Description Summary

The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The mission of the ACC Clinical Research Unit (CRU) is to advance the science of cancer care, serve our patients by improving clinical outcomes, and offer the best available innovative care to trial participants. The ACC CRU is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. The ACC CRU is currently comprised of 12 Research Teams that support disease/discipline specific cancer programs within the ACC. This Project Manager will have support of the ACC CRU-Breast Research Team.

The Project Manager position will directly report to the Lead Research Nurse and Team Manager of the Abramson Cancer Center (ACC), Clinical Research Unit (CRU) - Breast Research Team. The successful candidate will work closely with Physician leader of this ACC CRU Research Team and Lead Research Nurse and Team Manage to oversee aspects of the clinical research portfolio being performed for their research program. He/she will oversee the start-to-end processes for study start-up and ongoing study management. This includes assisting with study feasibility and selection, working closely with the ACC CRU Regulatory coordinators and/or ACC CRU Central to manage, review and initiate trials to ensure competitive activation and enrollment timelines. The Project Manager is expected to actively manage ongoing research projects, troubleshoot operational issues daily and assist with any and all aspects of clinical research coordinator's work during absences or when a specific team member's workload exceeds capacity (including, but not limited to, managing the team member's portfolio including budgets, patient visits, transporting specimens, data entry, query resolution and working with study monitors).

The Project Manager will work closely with major internal (PI, ACC CRU Central - Operations, Regulatory, Education/QA, Budget, Legal, Finance, Billing Compliance, Infusion/CHPS, Investigational Drug Services/Pharmacy) and external (sponsors, facilities, CROs, Subcontractors, Collaborators) stakeholders to support study start up and day to day operations, as needed, of clinical research activities for their team.

The Project Manager for the ACC CRU Breast Research Team will support Phase I-IV clinical trials. Additional activities may include serving as a backup to the clinical research coordinators in supporting recruitment, and enrollment of patients according to protocol requirements for their team. He/she may schedule patient visits and any necessary testing, monitor patients per protocol requirements and ensure adherence to protocol requirements, organize, and maintain all documentation required by the sponsor or CRO - includes source documentation, case report forms, and research charts. He/she 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. As needed, the Project Manager will assist in the development/maintenance of study specific case report forms and source document tools, show vigilance in patient safety, protocol compliance and data quality and adhere to the requirements of the University of Pennsylvania, GCP, FDA and all applicable regulatory bodies.

Job Responsibilities

Specific responsibilities include (but are not limited to):

• Support the Lead Clinical Research nurse with recruiting, interviewing, hiring, training and mentoring staff. Participate in maintaining up to date records and slide sets to present at weekly or recurring meetings with team leadership and team members to review the status of the studies in feasibility and start-up, financial status of studies, and protocol amendments; as well as patients in detail, items that are outstanding, and troubleshooting issues needing to be addressed
• Work with ACC CRU Central 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 progress.
• Perform group-specific regulatory activities, such as site selection visits, document completion (site selection questionnaires, 1572's and financial disclosure forms), and IRB and IND report completion (with investigator input), including AE reports, deviations, CRs and modifications. Work with regulatory to collect credentials documents from the study team and investigators. Work with regulatory and the lead nurse to ensure team trainings are up to date.
• 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. Also support patient reimbursement for clinical trial participation.
• May act as a back up to the clinical research coordinators in all capacities including: attending patient visits, transporting specimens, data entry, query resolution, working with study monitors, attending biopsies, and any other coordinator duty. The Project Manager may also have primary study coordinator responsibility for at least 1 study
• Work closely with the Regulatory Coordinators of the ACC CRU to manage the review and startup of trials. Submit complete Initial and Amendment study packets and logistical review forms to regulatory, along with appropriate study contacts.
• Work with the Lead Clinical Research Nurse to closely monitor and report the status of all studies within their group, including accrual, data entry, query resolution, deviations, identification and resolution of patient issues.
• Collect, review and report timely, valid, accurate study data for studies with patients on trials in long-term survival follow up. Obtain records required to complete case report forms. Update/maintain study record in the Clinical Trials Management System (CTMS) in real-time. Maintain clinical trial databases by completing case report forms typically within 5 business days of subject visits and resolving data queries within 10 days of issuance.
• The project manager will support quality assurance practices for the entire portfolio. Work closely with the lead nurse and the study team members to organize patient charts, schedule and conduct monitoring visits, internal and external audits, and provide responses to auditing bodies following audits and monitoring visits in partnership the Lead nurse.
• Collaborate with ACC CRU Central: Review of program metrics (performance, portfolio, enrollment); including quarterly Scorecard support with Breast leadership team. Timely communication of significant challenges encountered by the team. Participate in ACC CRU Central leader meetings and serve expert work groups as needed to enhance overall workflow efficiencies and quality of research. The candidate will work closely with the Breast Lead research nurse and ACC CRU Operations Manager to develop and implement SOPs, report team study metrics, and communicate issues that may affect overall research with ACC CRU Trials.
• Perform other duties as assigned

This position will require the Project manager to have a variable schedule. Research participants are seen in the clinical setting during early morning and early evening hours as well as daytime visits. Position involves work-related responsibilities that may occur outside of usual hours and some conference-related travel. Cross coverage and/or re-assignment amongst ACC CRU Research Teams is possible depending on business needs. Position is contingent on continued funding.

Qualifications

• Bachelor's Degree with 3-5 years of related experience or equivalent combination of education and experience is required. Effective problem-solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations. Oncology clinical research experience preferred.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$62,000.00 - $70,958.00 Annual Rate

Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.

To apply

visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Perelman-Center-for-Adv-Medicine/Project-Manager--Breast-Cancer-Clinical-Research_JR00117563-2