Clinical Research Project Manager ; OBGYN - Pregnancy

Clinical Research Project Manager A (OBGYN
- Pregnancy & Perinatal Research Center)

The 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.

Penn has been named one of America’s Best Large Employers in 2023.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

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 ist 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 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 Red Cap and Excel are required. Prior experience with multi-site clinical trials is preferred.

• Initiation and implementation of new study protocol (s), manages project activities; develops, implements and manages work plans and time frames to ensure project goals.
• Communicates project activities to ensure clear, coordinated project related communications
• Oversee and ensure recruitment and retention multiple studies, including a multi-site randomized controlled trial
• Hire and train specific research coordinators, supervises assigned personnel; delegates and coordinates tasks based on developed plans
• Work with faculty in the Divisions of Cardiology and Maternal Fetal Medicine, as part of the inter-disciplinary Pregnancy and Heart Disease Program, on multiple funded projects

Position contingent upon continued funding

• Bachelor's Degree with 3-5 years of clinical research and/or project management or equivalent combination of education and experience is required.
• Knowledge of pregnancy, preterm birth, and medical charts is required.
• Working and facile knowledge of Red Cap and Excel are required.
• Prior experience with multi-site clinical trials is preferred.
• Master's level education is preferred.
• Ideal candidates will bring a high degree of problem solving and communication skills.

Philadelphia, Pennsylvania

Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected…