Clinical Research Coordinator B (Dept. of Surgery)

The University of Pennsylvania is a world-renowned leader in education, research, and innovation. This position's primary function is to facilitate, promote, and ensure good clinical practice in the conduct of all research protocols in the Department/Center.

Responsibilities

• Prepare and process all Institutional Review Board (IRB)through the IRB and other regulatory groups as apropriate including initial submissions, amendments, continuing reviews, adverse events and serious adverse events
• Coordinate, organize and maintain all documentation required by sponsor or CRO (case report forms, source documentation, study and regulatory binders, subject binders)
• Assist in the coordination of Phase I-IV clinical trials
• Participate in the conduct of study audits by sponsors, CRO's, the FDA and other entities as required
• Schedule patient visits and any necessary testing
• Adhere to all University of Pennsylvania, ICF, and FDA guidelines
• Process and ship blood, urine and tissue as required per trial
• Conduct initiation, monitoring and closeout visits with sponsors and/or CROs
• Ensure proper screening and enrollment of all study participants, including administering informed consent and confirming subject study eligibility prior to participation
• Other duties and responsibilities as assigned

Benefits

• Health, Life, and Flexible Spending Accounts
• Tuition
• Retirement
• Time Away from Work
• Long-Term Care Insurance
• Wellness and Work-life Resources
• Professional and Personal Development
• University Resources
• Discounts and Special Services
• Flexible Work Hours
• Penn Home Ownership Services
• Adoption Assistance

Company

• Ivy League university offering undergraduate and graduate education
• Philadelphia, Pennsylvania, USA
• http://www.upenn.edu/
• Founded in 1740
• 10001+ employees

Qualifications

• Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required
• Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.

Required skills

• Adverse Event Reporting, Clinical Research Documentation, Clinical Trials Coordination, IRB Submissions, Multi-center Budget Management, Patient Enrollment, Regulatory Compliance, Study Audits

Experience

• 2-3 years