Clinical Research Project Manager B/C
About The Position
The University of Pennsylvania is hiring a Clinical Research Project Manager at level B or C in the Perelman School of Medicine. The role manages clinical research projects, including study start-up and daily operations, communications with external sites, recruitment and enrollment, troubleshooting, quality assurance and quality control, and study close-out. Level B oversees single- and/or multi-site studies, while level C manages mostly complex, multi-site studies. The position develops, creates, and reviews regulatory submissions and study materials, and assists with determinations related to investigational drugs, investigational devices, and clinical trial agreement exemptions. It also supports pre-award financial and grant activities and/or post-award invoicing and billing review. Responsibilities include training, mentoring, and supervising research staff, supporting protocol compliance and research quality, and completing performance appraisals. The positions are contingent upon grant funding.
Requirements
- Bachelor's degree with 5–7 years of related experience, or an equivalent combination of education and experience, for level B.
- Bachelor's degree with 7–10 years of related experience, or an equivalent combination of education and experience, for level C.
Nice To Haves
- For level B: Master's degree and 3–5 years of experience preferred.
- For level C: Master's degree and 5–7 years of experience preferred.
Responsibilities
- Manage clinical research projects, including study start-up, daily operations, external site communications, recruitment and enrollment, troubleshooting, quality assurance and control, and study close-out.
- Develop, create, and review regulatory submissions and study documents and tools, including protocols, consent forms, annual reports, source documents, training slides, manuals of procedures, Data Safety Monitoring Board charters, clinical report forms, and standard operating procedures.
- Assist with investigational new drug, investigational device, and clinical trial agreement exemption determinations.
- Assist with or conduct pre-award financial activities, including medical record abstraction or coverage analysis development, registrations, research billing numbers, contract timelines, budgeting, and grant-writing assistance.
- Assist with or conduct post-award financial activities, including invoicing and billing review.
- Train and supervise or assist in training research staff, including onboarding, data and lab management, protocol compliance, quality assurance and control, human-subjects protection, good clinical practice, staff mentoring, project assignments, and performance appraisals.
- Perform additional duties as assigned.
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 tuition assistance at other institutions for dependent children.
- Basic, matching, and supplemental retirement plans.
- Substantial time away from work during the year.
- Long-term care insurance.
- Wellness and work-life programs and resources.
- Professional and personal development resources.
- Access to University libraries, athletic facilities, cultural activities, and recreational resources.
- Employee discounts and special services.
- Flexible work options and hours.
- Forgivable home-ownership loan for eligible employees.
- Adoption assistance for qualified expenses, for up to two adoptions in the household.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
