Project Manager A

Trustees of University of Pennsylvania; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

University of Pennsylvania is seeking a Clinical Research Project Manager A to support Pregnancy & Perinatal Research Center initiatives. The role involves coordinating multiple clinical studies, handling regulatory documentation, and ensuring protocol adherence across two hospitals.

Responsibilities include developing protocol designs, data management, and presenting study updates while training staff and supporting audits as needed.

Qualifications

• BA/BS required and 3–5 years of clinical research or project management experience.
• Knowledge of pregnancy, preterm birth, and medical charts preferred.
• Prior experience with multi-site clinical trials is preferred.

Responsibilities

• Coordinate and manage multiple clinical research studies including subject recruitment, visits, and follow-up.
• Develop and implement study protocol designs, construct source documents, databases, and case report forms.
• Present monthly study updates at meetings and assist with data cleaning and interim analysis.
• Prepare and maintain regulatory documents including continuing reviews, modifications, and regulatory binders; assist with IRB submissions.
• Provide clinical services (e.g., phlebotomy, biospecimen processing) and train staff on core procedures.
• Oversee data entry, quality control, and ensure adherence to Good Clinical Practice across sites.

Skills

Multi-site clinical trials experience

Education

BA/BS

Tools

REDCap

Excel

Job description

University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023.

Posted Job Title

Project Manager A

Job Profile Title

Clinical Research Project Manager A

Job Description Summary

This position will support research projects for the Pregnancy & Perinatal Research Center under supervision of the Asst Director of Clinical Research Operations. The primary role of this position is the organization, coordination, and implementation of multiple clinical research studies. The essential functions of the position include but are not limited to: Develop and implement new/current study protocol design, construction of source documents, databases, and case report forms. Present monthly study updates at meetings. Assist with data cleaning and quality control for large volume interim analysis. Preparation and maintenance of regulatory documents including continuing reviews, modifications, and regulatory binders. Responsible for all aspects of clinical trial coordination including: subject recruitment, detailed data entry, subject visits and follow-up and regulatory documentation. Work with Asst Director of Clinical Research Operations to plan and lay groundwork for upcoming studies. Provide clinical services, including phlebotomy and biospecimen processing at patient visits, and be able to train on such processes. Actively troubleshoot and work as a problem solver in a large volume clinical setting to ensure full execution of protocols. Will participate in regulatory audits.

Knowledge of pregnancy, preterm birth, and medical charts is required. Working and facile knowledge of RedCap and Excel are required. Prior experience with multi-site clinical trials is preferred.

Job Responsibilities

• Develop processes, schedule and oversee subject visits and any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice ("GCP") (e.g. screening, calling patients beforehand, scheduling subject visits within the appropriate window, ensuring all tests and assessments at each visit are performed, coordinating procedures with physician/medical personnel/labs, detailed documentation of study activities).
• Provide oversight of one or more large studies- Maintain/create logs, calendars, and tracking tools to assure recruitment goals and follow-up visits are being conducted in the most productive manner.
• Develop and implement new/current study protocol design; train staff on flow of new/current studies and how to incorporate them into our current model.
• CRFs/REDCap - Develop and update CRFs in REDCap and train research staff in completion of CRFs. Monitor data entry, data quality, data issues. Adjudicate errors and provide training/feedback to staff in real time. Provide solutions for data issues including timely entry, errors, and forms.
• IRB Submission/Modifications - Submit modifications, deviations, and continuing review for multiple protocols. Train research staff to complete IRB submission for other protocols when applicable
• Oversee and manage direct staff. Complete performance evaluations, approve PTO, and all other duties associated with managing direct staff. Work with other Project Managers to provide feedback to CRCs that cross cover for studies.
• Work with clinical staff to ensure seamless and efficient integration of research personnel and projects in all areas of two departments (Cardiology and Ob/Gyn) at two hospitals.
• Perform additional duties as assigned

Qualifications

• BA/BS and 3-5 years of clinical research or project management experience or equivalent combination of education and experience required.

Job Location - City, State

Philadelphia, Penns