Clinical Research Assistant
Job location: Perelman Center for Adv Medicine
Employment Type: Full-time
Posted data: 2021-02-10
University OverviewThe 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.Posted Job TitleClinical Research AssistantJob Profile TitleClinical Research Assistant AJob Description SummaryResponsible to assist with study coordination and recruitment for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects within a specific Division, under close supervision. Works directly with study physicians, research coordinators, project managers, and other research staff. Performs screening visits, consenting of participants, processing and shipping of labs, entering data into databases, and escorting participants to other testing/procedure areas. Help advance the research mission of the Division and University.Job Description
This individual will work under supervision from the Program Manager and/or a Clinical Research Coordinator C:
Assist coordinators with initiating study procedures for new industry-sponsored and investigator-initiated clinical trials. Organize, participate and assist in the preparation of documents needed for initiation, monitoring, internal and external auditing, and study close-out visits.
Assist with coordination of complex (i.e. multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I – IV clinical trials and registries within the Clinical Research Program. Complete relevant training to function in the role including but not limited to electronic databases, and processing/shipping specimens. Conduct screening of patients in electronic medical records and clinic schedules. Be actively involved in the planning and implementation of patient recruitment into studies.
Develop, schedule and oversee subject visits and any necessary sample collection schedules including specimen collection for biobanking studies, coordinating sample drop-off at labs across the Health System and other activities according to protocol and in accordance with Good Clinical Practice (“GCP”). Monitor subjects per protocol requirements and ensure adherence to protocol. Show vigilance in patient safety, protocol compliance and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines.
Participate in the completion of study specific case report forms and source document tools. May include the development and management of REDCAP web sites for internet data capture. Organize and maintain all documentation required by the sponsor or CRO per GCP – includes source documentation, case report forms, and research charts.
Collect, review and report timely, valid, accurate study data. Obtain records required to complete case report forms. Update/maintain study record in the Clinical Trials Management System (CTMS) in real-time. Maintain clinical trial databases by completing case report forms within 5 business days of subject visits and resolving data queries within 10 days of issuance. These timelines may be shortened during periods of data lock or in preparation for abstract/manuscript submission.
Coordinate and participate in core study team, disease-site group and ongoing protocol training/compliance meetings. Prepare agendas and record minutes for circulation. Provide regular updates to the research team and unit managers. Assist unit managers in meeting project timelines.
H.S. Diploma or GED Required, with 1-2 years of related experience or equivalent combination of education and experience, Bachelor’s degree preferred. The successful candidate must have: (1) basic understanding of or familiarity with Phase I-IV industry sponsored clinical trials or investigator-initiated trials; (2) effective verbal and written communication skills; (3) ability to learn new methods quickly and multi-task; (4) demonstrated ability to work as part of a team as well as independently; (5) initiative and interest in growing and learning about cancer research; (6) ability to work flexible hours.
This position is contingent upon funding.Job Location - City, StatePhiladelphia, PennsylvaniaDepartment / SchoolPerelman School of MedicinePay Range$16.23 - $29.22Affirmative Action Statement
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.Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.