Cardiac Surgery Program Manager (Department of Surgery)

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Posted Job Title

Cardiac Surgery Program Manager (Department of Surgery)

Job Profile Title

Clinical Research Program Manager C

Job Description Summary

The Cardiac Surgery Program Manager will manage clinical research coordinators and associated research staff within Department of Surgery at The Hospital of the University of Pennsylvania (HUP) and Penn Presbyterian Hospital (PPMC), and Chester County Hospital (CCH). The Program Manager will assess the workload of the staff and properly delegate responsibilities and provide guidance as needed. This includes tasks relevant to ongoing studies as well as the initiation of new clinical trials, which includes negotiation of new clinical trial agreements and associated budgets. The Program Manager will be the principal support in protocol development consistent with the Division's overall research mission. The Program Manager will be responsible for ensuring proper certification, licensure, and training documents are kept up to date for the research staff as well as the clinical team who help execute research studies. The Program Manager will be responsible for training new staff members and provide on-going continuing education for current staff.

Position is contingent upon continued grant funding.

Job Responsibilities

• Manage clinical research coordinators and associated research staff within programs at HUP and PPMC. This includes determining workload and assignments for staff; participating in hiring and evaluation of staff at both sites; continually assessing staff performance at all phases of orientation, assess clinical staff compliance with protocol on ongoing basis to minimize issues of non-compliance at both sites. Provide resources and mentorship for current staff and new hires.
• Coordinate conduct of Phase I-IV clinical trials for patients seen within the programs at HUP and PPMC. This includes oversite of study interventions, coordination of imaging and laboratory findings, screening and consenting patients, confirming eligibility, respond to queries, obtain records to complete related case report forms, oversee completion of CRFs and the shipment of blood and explanted devices required per protocol.
• Protocol Development : Principal support in the development of Physician-Modified Investigational Device Exemptions (PS-IDE) and other clinical protocols for the Division's overall research mission. Prepare draft PS-IDE applications for faculty review and submission to FDA. Draft components of clinical protocols and informed consents documents in collaboration with faculty.
• Regulatory-Financial-Training / Continuing Education : Negotiate clinical trial agreements and budgets; conduct study initiation; maintaining study regulatory binders; submission of all regulatory paperwork to our institutional review board (IRB) and any applicable central IRBs; monitoring; and closeout visits with sponsors and / or CROs. Create orientation programs for new hires and continuing education programs for current staff. Additionally, this includes in-service to any applicable clinical staff prior to initiation of a clinical study and any necessary refresher training throughout the duration of the study.
• Develop, maintain, and analyze databases for JCAHO survey scheduled and unscheduled visits. This includes prepping reports to provide mandatory endpoints and outcomes required for Joint Commission recertification.

Position is contingent upon continued grant funding.

Qualifications

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$74,476.00 - $117,901.00 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, as well as internal and market factors and grade profile.

Equal Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

Special Requirements

Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

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