Clinical Research Coordinator A
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/
The primary role of Clinical Research Coordinator is the organization, coordination and implementation of a research study. The research coordinator will be responsible for all aspects of clinical trial coordination including: subject recruitment, detailed data entry, subject visits and follow-up and regulatory documentation.
- Be actively involved in planning and implementation of patient recruitment into studies (involves deciding which strategies are best, reaching out to potential recruitment sites/referring physicians, dropping off/posting recruitment materials, etc)
- Collect and report timely, valid, accurate data—maintain clinical trial databases. Respond to data queries. Maintain subject files and regulatory files per GCP
- Collect and process biospecimens (includes performing venipuncture)
- Prepare protocols, informed consents, data collection forms and advertisements for regulatory approval. Coordinate study start up activities. Participate in budget preparation for trials. Be responsible for tracking site reimbursements and allocating patient stipends.
- Perform required research activities per protocol and in accordance with Good Clinical Practice (scheduling subject visits within the appropriate window, ensuring all tests and assessments at each visit are performed, reporting adverse events and ensuring review and appropriate follow-up by investigator, administering drug treatments and/or procedures and monitoring patient care and treatment side effects in concert with investigators, detailed documentation of study activities)
- Screen, recruit and retain potential study participants. Obtain informed consent at multiple study sites within the Penn Health System (includes approaching potential subjects in the office, or speaking to them by phone, reviewing their medical records and discussing with investigators, asking pre-screening eligibility questions, etc)
- Assist investigators with intellectual tasks as needed (including literature reviews, contributions to manuscripts, etc)
- Interface with regulatory authorities and sponsors. Attend Investigator Meetings for clinical research trials. Organize and participate in site visits, both initiation and otherwise. Prepare for and host both internal and external auditing and monitoring activities.
- Other duties and responsibilities as assigned.
Position is contingent on continued funding.
A Bachelor’s degree and 1 to 3 years of experience or equivalent combination of education and experience required. Position requires a highly motivated, articulate individual with excellent oral and written communication skills. The candidate should possess the ability to work independently and also as a part of a team. Strong planning, organizational and prioritizing capabilities along with problem solving skills desired. Must be able to work flexible hours.
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.