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University of Pennsylvania

Ivy League university in Philadelphia, PA

Clinical Research Project Manager A

Clinical Research OperationsPosted on Nov 11
Full-timePhiladelphia, PA, USA$63.1k - $71k /yrIn-person

About the Job

Requirements

  • A BA/BS and 3–5 years of clinical research or project management experience, or an equivalent combination of education and experience, are required.
  • Knowledge of pregnancy, preterm birth, and medical charts is required.
  • Working and facile knowledge of REDCap and Excel is required.

Responsibilities

  • Develop processes, schedule, and oversee subject visits and any necessary testing and appointment coverage according to protocol and Good Clinical Practice, including screening, calling patients beforehand, scheduling visits within the appropriate window, ensuring tests and assessments are performed, coordinating procedures with physicians, medical personnel, and laboratories, and documenting study activities.
  • Provide oversight of one or more large studies; maintain or create logs, calendars, and tracking tools to support recruitment goals and follow-up visits.
  • Develop and implement new and current study protocol designs, and train staff on study flow and integrating studies into the current model.
  • Develop and update case report forms in REDCap, train research staff to complete them, monitor data entry, data quality, and data issues, adjudicate errors, provide real-time staff training and feedback, and resolve data issues including timely entry, errors, and forms.
  • Submit Institutional Review Board modifications, deviations, and continuing reviews for multiple protocols, and train research staff to complete submissions for other protocols when applicable.
  • Oversee and manage direct staff, complete performance evaluations, approve paid time off, and perform other duties associated with managing direct staff. Work with other Project Managers to provide feedback to clinical research coordinators who cross-cover studies.
  • Work with clinical staff to integrate research personnel and projects efficiently across Cardiology and Obstetrics and Gynecology departments at two hospitals.
  • Perform additional duties as assigned.
  • Organize, coordinate, and implement multiple clinical research studies.
  • Construct source documents, databases, and case report forms; present monthly study updates; assist with data cleaning and quality control for large-volume interim analysis; and prepare and maintain regulatory documents, including continuing reviews, modifications, and regulatory binders.
  • Coordinate all aspects of clinical trials, including subject recruitment, data entry, subject visits and follow-up, and regulatory documentation.
  • Work with the Assistant Director of Clinical Research Operations to plan and prepare upcoming studies.
  • Provide clinical services, including phlebotomy and biospecimen processing during patient visits, and train others in these processes.
  • Troubleshoot clinical workflow issues to ensure protocols are fully executed, and participate in regulatory audits.

Desired Qualifications

  • Prior experience with multi-site clinical trials is preferred.

About the Company

University of Pennsylvania

Ivy League university in Philadelphia, PA

The University of Pennsylvania is a private Ivy League research university in Philadelphia. It comprises twelve undergraduate, graduate, and professional schools, including the Wharton School, Perelman School of Medicine, and Penn Carey Law.

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