Clinical Research Coordinator
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. http://www.med.upenn.edu/
This position will support multiple clinical trials for the MFM Research Program under supervision of the Clinical Research Unit Project Manager. The primary role of this position is the organization, coordination, and implementation of multiple clinical trials, including those sponsored by pharma, investigator initiated and NCTN studies. The individual will be responsible for working with a team of nurses and coordinators to consent, enroll, assure protocol compliant treatment and assessments and follow-up patients for multiple clinical trials. The candidate must be enthusiastic and possess leadership qualities exhibited in a positive, team building demeanor, with demonstrated capability.
The essential functions of the position include but are not limited to: Construction of source documents, data collection and tabulation instruments and reports. Present monthly study updates at clinical trials meetings, and update clinical data bases in real time, including sharepoint and Velos. Provide clinical services, including phlebotomy and biospecimen processing and shipping. Has investigational product accountability, including working with IDS and IVRS/IWRS systems, documentation and delivery to subjects, providing and collecting and recording drug diaries/calendars. Prepare for and participate in monitoring visits and audits. Preparation of progress reports for yearly regulatory continuing review.
Will be responsible for all aspects of clinical trial coordination including: subject enrollment, detailed data entry into multiple EDC systems, subject visits, (which includes scheduling of visits and clinical assessments according to protocol), follow-up and regulatory documentation (for SAEs and safety reporting). Work with program director to plan and lay groundwork for continued expansion of clinical trial menu. Actively troubleshoot and work as a positive problem solver in a large volume clinical setting to ensure full execution of protocols. Responsible for assisting in clinical trial start up, including but not limited to the development of electronic templates for protocol treatment of oncology patients, constructing prospective reimbursement analysis with supporting documentation, obtaining Research Billing Numbers, scheduling and participating in Site qualification and Initiation visits.
A Bachelor’s Degree and 2 to 4 years of experience or an equivalent combination of education and experience required. Knowledge of women’s health and medical charts is required. Experience with EDC systems and EMR is required.
Effective communication and writing skills; ability to multi-task and problem solve. Energetic, interactive and demonstrated ability to work as part of a team as well as independently; knowledge of IRB regulations. Must possess strong computer skills and be able to independently and proficiently work in MS office suite.
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.