Clinical Research Project Lead — Neuromodulation Trials

University of Pennsylvania; United States; On-site; USD 63,000 - 78,000; Full time

Job summary

University of Pennsylvania is seeking a Clinical Project Manager A to oversee the operational and regulatory conduct of interventional neuromodulation trials. The role coordinates across a collaborating site and device partner, with NIH/NIMH and NIDA funding and FDA record-keeping obligations.

Under guidance from the Principal Investigator, you will manage day-to-day operations, regulatory files, protocol development, and data quality control, while supporting grant applications and NIH progress

Qualifications

• Bachelor's degree with 3–5 years of related experience; IRB submissions and FDA-regulated (IND/IDE) research experience preferred.
• Experience with device trials, neuromodulation, psychiatric or neurological populations is a plus.
• Strong organization, written communication and ability to manage competing deadlines.

Responsibilities

• With supervision, manage single- and multi-site clinical research projects including study start-up, daily operations, communication with the collaborating site and device partner, recruitment and enrollment tracking against NIH milestones, troubleshooting, quality assurance and quality control, and study close-out.
• Coordinate device delivery, training and session scheduling with the device manufacturer; maintain device accountability records. May include study visits and procedures when needed to meet the needs of the project.
• Develop, create and review regulatory submissions and study documents and tools, including protocols, consent forms, IRB modifications and continuing reviews, annual reports, source documents, training materials, manuals of procedures, Data and Safety Monitoring Board charters and meeting packets, case report forms and SOPs.
• Assist with pre- and post-award activities (clinical trials management system registration, Medicare analysis, contracts) and NIH reporting (RPPR, milestone reports, NIMH data submissions).
• Assist and train direct and indirect clinical research staff per protocol, including onboarding, data management, protocol compliance, and staff performance reviews.

Skills

IRB submissions

FDA-regulated research

Good Clinical Practice (GCP)

Multi-site coordination

Education

Bachelor's degree with 3–5 years of related experience

Job description

University of Pennsylvania is seeking a Clinical Project Manager A to oversee the operational and regulatory conduct of interventional neuromodulation trials. The role coordinates across a collaborating site and device partner, with NIH/NIMH and NIDA funding and FDA record-keeping obligations.

Under guidance from the Principal Investigator, you will manage day-to-day operations, regulatory files, protocol development, and data quality control, while supporting grant applications and NIH progress