Clinical Research Coordinator B at The University of Pennsylvania in HUP

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. 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. Posted Job Title Clinical Research Coordinator B Job Profile Title Clinical Research Coordinator B Job Description Summary This position's primary function is to facilitate, promote, and ensure good clinical practice in the conduct of all research protocols at the Neurology PAH Parkinson's Disease and Movement Disorders Center. The coordinator will independently manage different phases of complex clinical trials. They will coordinate the screening of patients, subject enrollment, collection and storage of biological samples, updates and maintenance of regulatory documents, and collection and management of clinical data. They will work with the IRB as well as other internal and external partners to ensure that all study documentation is submitted appropriately for initial approval and continuing maintenance. Job Description This position will function as lead coordinator on several complex phase I-IV studies. They will coordinate protocol compliance, enrollment and retention of subjects, management of subject visits, management of study drug or devices, and regulatory submissions. This includes recruitment, consent, and screening of patients into the protocol, scheduling subject visits, monitoring and ensuring adherence to protocol requirements, and subject training. They will maintain organized study documentation including source documents, case report forms, subject binders, regulatory binders, and electronic data entry. They will be responsible for collecting, reviewing, and reporting study data, completing data entry, and resolving queries. They will manage all aspects of subject visits including subject training and retention, completion of assessments and questionnaires (PROs), and collection, processing, and shipping of laboratory samples. Assessments may include ECG/EKGs, vital sign collection, cognitive testing, training subjects on study devices or programs, review of medications and medical history, review and reporting of adverse events, etc. This position will participate in study start up, ongoing study maintenance, monitoring, audits, and close out visits. They will attend study team meetings and ongoing protocol training or compliance meetings. They will develop and maintain study specific source documents, regulatory submissions, and regulatory documents/binders. They will review internal budgets, complete research billing, invoice the sponsor, and set up subject payments per budget. Qualifications Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required Excellent verbal/written com