Clinical Research Project Manager B/C

University of Pennsylvania•Philadelphia, PA

5d•$75,804 - $106,940

About The Position

The University of Pennsylvania is hiring a Clinical Research Project Manager B/C to support clinical research studies in the Cardiovascular Division of PPMC. The role provides project management and operational leadership for assigned studies, with responsibility for study planning, execution, enrollment performance, and coordination across investigators, research staff, core laboratories, partner sites, sponsors, and other collaborators. The position operates with substantial independence and escalates strategic decisions and high-level study direction to senior leadership. Responsibilities vary by level. Project Manager B independently manages complex, multi-site cardiovascular studies and oversees study operations, recruitment, enrollment, timelines, and staff. Project Manager C leads day-to-day operations across multiple projects and additionally has leadership responsibilities that include hiring, onboarding, staff supervision, project strategy, and development of study documents. Both levels support protocol-compliant research, oversee compliance and audit readiness, mentor staff, and contribute to consistent processes, best practices, and standard operating procedures. The work includes reviewing protocols; screening and enrolling participants; explaining protocols and consent forms; maintaining signed consents, subject binders, source documents, worksheets, regulatory files, and study data; completing and entering case report forms; obtaining medical records; entering research information into electronic medical records; resolving sponsor and CRO data queries; and coordinating study drug availability with pharmacists as needed. The role also supports multicenter coordination, external collaborations, study visits and follow-up, adverse-event reporting, and the creation of EPIC Smart Phrases. The position is contingent upon favorable funding.

Requirements

For Project Manager B: Bachelor’s degree and 5–7 years of related experience, or an equivalent combination of education and experience.
For Project Manager C: Bachelor’s degree and 7–10 years of related experience, or an equivalent combination of education and experience.
Experience managing complex, multi-site clinical research studies and coordinating study operations, recruitment, and enrollment.
Ability to conduct research according to approved protocols, Good Clinical Practice, and applicable regulatory requirements.
Experience or ability to screen, recruit, and consent research participants and determine eligibility using medical records and inclusion/exclusion criteria.
Ability to maintain study documentation, regulatory files, source documents, case report forms, subject binders, and electronic medical record information.
Ability to supervise, train, and mentor research staff.
Ability to coordinate with investigators, study teams, sponsors, CROs, core laboratories, and external collaborators.

Nice To Haves

For Project Manager B: Master’s degree and 3–5 years of experience preferred.
For Project Manager C: Master’s degree and 5–7 years of experience preferred.

Responsibilities

Independently manage complex, multi-site cardiovascular clinical research studies, including daily operations, coordination, recruitment and enrollment oversight, and troubleshooting in collaboration with the Principal Investigator.
Develop and maintain study project plans, timelines, recruitment strategies, and operational plans; track progress, meet study milestones, and identify and resolve operational challenges.
Coordinate activities among investigators, coordinators, research staff, core laboratories, partner sites, sponsors, CROs, and other external collaborators.
Supervise, recruit, onboard, train, and mentor research staff; manage workloads, assignments, performance expectations, and, for Project Manager C, staff appraisals.
Conduct protocol-based research in accordance with Good Clinical Practice (GCP), applicable regulatory requirements, and human-subject protections.
Review study protocols, attend investigator meetings, maintain delegation-of-duties and authorized-signature records, and coordinate with pharmacists regarding study drug availability as needed.
Screen potential participants, verify eligibility through medical-record review and communication with clinical staff, recruit and consent participants, and maintain screening and enrollment logs.
Complete and maintain source documents, worksheets, case report forms, subject binders, research data, regulatory files, and signed consent forms; obtain records needed to complete case report forms.
Ensure enrollment information, research orders, and other communications are entered into each participant’s electronic medical record; resolve data queries from sponsors and CROs.
Oversee compliance reviews and ensure audit and inspection readiness for assigned studies.
Support study visits, follow-up activities, medical and demographic data abstraction, and adverse-event reporting.
Promote consistent study processes, tools, and documentation, and contribute to best practices and standard operating procedures.
Develop or help create EPIC Smart Phrases.
For Project Manager C, lead project strategy and study-document development and oversee the detailed operations of clinical research activities, including recruitment, research visits, and data entry.

Benefits

Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits.
Flexible spending accounts for eligible health care and dependent care expenses.
Tuition assistance for employees, spouses, and dependent children, including eligible assistance at other institutions for dependent children.
Basic, matching, and supplemental retirement plans, with pre-tax or Roth savings options and investment choices through TIAA and Vanguard.
Substantial time away from work.
Long-term care insurance.
Wellness and work-life programs and resources.
Professional and personal development resources.
Access to university resources, libraries, athletic facilities, cultural activities, and recreational activities.
Employee discounts and special services, including arts, entertainment, transportation, and other goods and services.
Flexible work options and hours.
Forgivable home-ownership loan for eligible employees interested in buying a home or residing in West Philadelphia.
Adoption assistance reimbursement for eligible adoption expenses.