"Multi-Institution Project Manager"

Posted Job Title

Multi-Institution Project Manager

Job Profile Title

Clinical Research Project Manager B

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 Multi-Institution Project Manager will have oversight of the ACC CRU- Lymphoma Research Team's Therapeutic Multi-Institution portfolio. The Project Manager position will directly report to the ACC CRU- Lymphoma Research Program Manager and indirectly report to the Physician Leader of the ACC CRU- Lymphoma Research Team. Initial work will focus on supporting current multi-site efforts within ACC CRU- Lymphoma's Investigator-initiated trial (IIT) portfolio and management of upcoming multi-site therapeutic opportunities where PCAM/HUP is the lead site. Responsibilities may include overseeing faculty-held IND projects. The successful candidate will work closely with Physician Investigators, the Program Manager, Lead Research Nurse, and other IIT Sponsor/Site team members as delegated to oversee all aspects of our multi-site IITs, including start-to-end processes for study start-up and ongoing study management for these projects. This includes troubleshooting operational issues as they arise, working closely with internal and external stakeholders to ensure patient safety/adherence to the protocols and to support important project goals/endpoints.

Job Description

This individual will be responsible for coordinating and facilitating all elements of study planning, implementation and operations at external enrollment sites, including, but not limited to:

• Study start-up, daily operations, external site communications, recruitment and enrollment, and troubleshooting; Quality Assurance & Quality Control; study activation and close out activities.
• Create and review regulatory submissions. In collaboration with Principal Investigators, research team leaders, and delegated IIT team members, develop and review study documents/tools, including protocols, consents, annual reports, source documents, training slides, Study Manual of Procedure (MOP), DSMB charter, and Case Report Forms (CRFs). Assist with IND/IDE/CTA exemption determinations.
• Provide ongoing administrative and operational support to PI's related to multi-site projects. Attend, create presentations for, and coordinate meetings (e.g. physician feasibility discussions, Site Initiation Visits, trainings, etc.).
• Generate and provide data and reports as necessary for study endpoints and publications.
• Assist with training of direct and/or indirect research staff in study procedures as required by protocol(s). Includes data and lab management, protocol compliance and QC/QA.
• Serve as the primary contact for all sites for any study related issues; escalate to research team leaders as needed.
• Ensure adherence to study timelines and protocol/procedures.
• Assist with pre-award finance activities (driving contract timelines, budgeting input or development, grant writing assistance); and/or post-award finance activities (invoicing, billing review)
• Demonstrate vigilance in patient safety, protocol compliance and data quality. Adhere to all University of Pennsylvania, IRB, CTSRMC, FDA, applicable Federal, State and Local, as well as GCP guidelines.

Qualifications

The minimum of a bachelor's degree (in a relevant discipline, biological sciences preferred) and 5 to 6 years of experience or an equivalent combination of education and experience is required, master's degree (in a relevant discipline) and 3 to 4 years of experience, or equivalent combination of education and experience is preferred. Experience in a hospital academic medical setting or pharmaceutical experience with principal responsibilities related to the direct conduct of clinical trials and/or research operations is required. Oncology clinical trial experience preferred. Thorough knowledge of GCP, and relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) and Good Clinical (Research) Practice (GCP) Guidelines. Demonstrated project and time management skills are necessary; must be able to work independently with minimal supervision. Outstanding organizational skills and the ability to function in a team environment. Qualified candidates must also demonstrate excellent written and verbal communication skills; advanced computer software skills; must be able to work in a fast-paced environment with time sensitive deadlines and competing priorities; the ideal candidate will have very strong analytical and critical thinking skills, and the ability to build and maintain positive working relationships at all levels of the institution and external collaborators/sites.

Position is contingent upon continued funding.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$74,500.00 - $81,441.00 Annual Rate