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. 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 A Job Profile Title Clinical Research Coordinator A Job Description Summary The Penn Huntington's Disease Center is seeking a highly motivated and detail-oriented Clinical Research Coordinator A (CRC A) who will be responsible for the coordination of multiple industry-sponsored and investigator-initiated clinical studies through their entire lifecycle (startup, conduct and closeout). Primary responsibilities include but are not limited to: 1) Reviewing and comprehending assigned protocols, including study procedures and timelines, to ensure that clinical research and related activities are performed in accordance with protocol, SOP, GCP and applicable regulatory requirement, 2) Facilitating the approval of new study agreements and contracts, 3) Assisting with the development of study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs, 4) Recruiting and enrolling study participants, coordinating study visits and serving as liaison between the participant, PI, members of the study team and external Sponsor/CRO teams, 5) Collecting clinical data, completing source documents, and collecting, processing and shipping biological samples, 6) Completing case report forms according to source documents and responding to data clarification requests in a timely manner, 7) Establishing and maintaining study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required, 8) Preparing and managing regulatory submissions and inquiries, and 9) Coordinating and attending Investigator Meetings, Site Selection visits, Routine monitoring visits, and study close out visits. As applicable, the CRC A will work closely with the study PI and study team to identify problems, develop solutions, implement approved changes to procedures and monitor results. The CRC A will promote institutional values of patient and visitor satisfaction by demonstrating courtesy and respect for patients and their families, visitors and other employees. The CRC A will demonstrate competence in the assessment, treatment and care of patients, and is expected to exhibit a professional and compassionate demeanor in performance of responsibilities and to be unfailingly responsive to the needs of patients. The position may require communication with patients and staff outside of office hours. The position is contingent on continued funding. Job Description The Penn Huntington's Disease Center is seeking a highly motivated and detail-oriented Clinical Research Coordinator A (CRC A) who will be responsible for the coordination of multiple industry-sponsored and investigator-initiated clinical studies through their entire lifecycle (startup, conduct and closeout). Primary responsibilities include but are not limited to: 1) Reviewing and comprehending assigned protocols, including study procedures and timelines, to ensure that clinical research and related activities are performed in accordance with protocol, SOP, GCP and applicable regulatory requirement, 2) Facilitating the approval of new study agreements and contracts, 3) Assisting with the development of study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs, 4) Recruiting and enrolling study participants, coordinating study visits and serving as liaison between the participant, PI, members of the study team and external Sponsor/CRO teams, 5) Collecting clinical data, completing source documents, and collecting, processing and shipping biological samples, 6) Completing case report forms according to source documents and responding to data clarification requests in a timely manner, 7) Establishing and maintaining study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required, 8) Preparing and managing regulatory submissions and inquiries, and 9) Coordinating and attending Investigator Meetings, Site Selection visits, Routine monitoring visits, and study close out visits. As applicable, the CRC A will work closely with the study PI and study team to identify problems, develop solutions, implement approved changes to procedures and monitor results. The CRC A will promote institutional values of patient and visitor satisfaction by demonstrating courtesy and respect for patients and their families, visitors and other employees. The CRC A will demonstrate competence in the assessment, treatment and care of patients, and is expected to exhibit a professional and compassionate demeanor in performance of responsibilities and to be unfailingly responsive to the needs of patients. The position may require communication with patients and staff outside of office hours. The position is contingent on continued funding. Qualifications Bachelor's Degree with 1-3 years of related experience in research and clinical study methodologies or equivalent combination of education and experience is required Working Conditions Office, Library, Computer Room; Requires extensive safety Physical Effort Typically sitting at a desk or table; Occasional lifting 25 lb. or less
