Ophthalmic Clinical Trials Lead

University of Pennsylvania Perelman School of Medicine; United States; On-site; USD 57,000 - 69,000; Full time

Job summary

The University of Pennsylvania Perelman School of Medicine in Philadelphia, PA, is seeking a Clinical Research Coordinator C to oversee major trials and ensure protocol adherence. The coordinator will support study teams, manage regulatory submissions, data quality, and audits.

The ideal candidate has a Bachelor of Science and 4–6 years of experience or equivalent, with strong clinical research coordination and regulatory compliance skills.

Qualifications

• Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required.

Responsibilities

• Coordinate Phase I-IV clinical trials (prior experienced required).
• Recruit, consent, and screen patients according to protocol.
• Schedule patient visits and any necessary testing; monitor patients per protocol requirements.
• Organize and maintain all required documentation including source documentation, case report forms, and research charts; collect, review and report study data; complete case report forms and resolve data queries.
• Process and ship study specimens including blood, urine and tissue samples.
• Participate in initiation, monitoring, audit, and close-out visits; participate in study team meetings and protocol training/compliance meetings.
• Assist Project Managers with study start-up for new clinical trials including working with OCR Finance and Legal with completion of CTA and Budget.
• Develop/maintain study specific case report forms and source document tools.
• Participate in coordination of Phase I-IV clinical trials (10% Essential: prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all other applicable review).
• Assist Project Managers in training new staff.
• Other duties and responsibilities as assigned.

Education

Bachelor of Science

Job description

The University of Pennsylvania Perelman School of Medicine in Philadelphia, PA, is seeking a Clinical Research Coordinator C to oversee major trials and ensure protocol adherence. The coordinator will support study teams, manage regulatory submissions, data quality, and audits.

The ideal candidate has a Bachelor of Science and 4–6 years of experience or equivalent, with strong clinical research coordination and regulatory compliance skills.