Clinical Research Coordinator A at University of… · Philadelp…

Summary: The University of Pennsylvania is a world-renowned leader in education, research, and innovation. The Penn Neurogenetics Therapy Center is seeking a highly motivated Clinical Research Coordinator A who will be responsible for the coordination of assigned clinical studies through their entire lifecycle. Responsibilities: - 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 - Facilitating the approval of new study agreements and contracts - Assisting with the development of study materials including but not limited to, the informed consent document, case report forms (CRFs), study logs - 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 - Collecting clinical data, completing source documents, and collecting, processing and shipping biological samples - Completing electronic case report forms according to source documents and responding to data clarification requests in a timely manner - Establishing and maintaining study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required - Preparing and managing regulatory submissions and inquiries - Coordinating and attending Investigator Meetings, Site Selection visits, routine monitoring visits, and study close out visits - Working closely with the study PI and PNTC study team to identify problems, develop solutions, implement approved changes to procedures and monitor results - Training junior members of the research team - Communicating with patients and staff outside of office hours Required Qualifications: - Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required - The CRC A should be highly motivated and detail-oriented - The CRC A should have strong planning, organizational, multi-tasking, and prioritizing capabilities - The CRC A should possess the ability to work independently and also as part of a team - The CRC A should have a strong ability to communicate with clinicians, researchers, sponsors, patients and families Preferred Qualifications: - Prior experience with industry-sponsored trials - Prior experience with start-up activities (financial and regulatory) - Prior experience with ethics committees - Prior experience with human subject research policies and practices Required Skills: Clinical research coordination, Protocol review, Clinical Practice (GCP), Regulatory compliance, Study startup activities, Informed consent process, Case report forms (CRFs), Data collection, source documentation, Biological sample processing, Regulatory submissions, Industry-sponsored clinical trials, Human subject research policies, Multi-tasking, Prioritizing, Planning Benefits: Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars., Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions., Retirement: Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard., Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be., Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you’re newly hired, you won’t have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting., Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That’s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance., Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally., University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries. There’s always something going on at Penn, whether it’s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you’re right in the middle of the excitement—and you and your family can enjoy many of these activities for free., Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks., Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures., Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements., Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.