Senior Clinical Research Operations Specialist

Pennsylvania, United States
29 Oct 2018
End of advertisement period
29 Dec 2018
Contract Type
Full Time

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 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 Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education.

The Senior Clinical Research Operations Specialist is an integral part of the Operation Unit in the Office of Clinical Research (OCR). Under the direction of the Senior Director of Clinical Research Operations, the Senior Clinical Research Operations Specialist will work to promote, support and facilitate clinical research by acting as a central resource to the clinical research faculty and staff at the Perelman School of Medicine. The Senior Clinical Research Operations specialist will serve as a resource to develop an overall IT strategy to support clinical research within PSOM. The Senior Clinical Research Operations Specialist will be expected to develop workflows and standards around research clinical systems. The role will also be responsible for generating standard metrics from research inventory systems.

This position is responsible for providing support and project management for the IT clinical research infrastructure that includes: Work with the Senior Director of Clinical Research Operations to develop an overall IT strategy to support clinical research at PSOM; Serve as the operational project manager to lead the implementation and integration of a Clinical Trial Management System (CTMS) and Electronic Data Capture System (EDC); Serve as the liaison between the PennChart research operations team and other IT teams within OCR and PMACS; Implementation, workflow development and/or training with respect to CTMS and EDC platforms; Serve as the lead of the IT implementation project -run meetings, set agendas, create action items, project charters and set priorities for a wide variety of stakeholders in order to move overall systems project forward; Conduct QA review of systems data on an as needed basis and serve as a resource to the Penn community from a research systems standpoint; Generate metrics and data for senior leadership from research inventory systems; Ability to interact with a variety of stake holders to move the overall IT implementation project forward.

The minimum of a Bachelor’s degree and two years of progressively responsible experience in business systems analysis and/or clinical research trial operations/project management or an equivalent combination of education and experience required. Master’s degree and/or additional years of experience strongly preferred;

Understanding of data management best practices; direct experience with the development of workflows around document management; understanding of IT requirements and regulations that surround clinical research; ability to take initiative and think strategically; demonstrated ease and comfort working with a wide range of personnel; excellent communication and effective writing skills.

Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.