Location: Philadelphia,PA, USA
Reference #: 1013092 SHIFT:Day (United States of America)Seeking Breakthrough MakersChildren's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation.At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care-and your career.CHOP's Commitment to Diversity, Equity, and InclusionCHOP is committed to building an inclusive culture where employees feel a sense of belonging, connection, and community within their workplace. We are a team dedicated to fostering an environment that allows for all to be their authentic selves. We are focused on attracting, cultivating, and retaining diverse talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children.We strongly encourage all candidates of diverse backgrounds and lived experiences to apply.A Brief Overview This role functions autonomously in a research setting and is responsible for managing 1) all administrative activities related to the NICHD-funded Intellectual and Developmental Disabilities Research Center (IDDRC) and 2) provide broad research administrative support for a wide range of grant-related activities for the Center for Autism Research (CAR). The IDDRC and CAR work closely with one another and share common leadership. The Clinical Research Program Manager will be integrated across both entities. The Clinical Research Program Manager will focus on serving as the lead administrator for the IDDRC and secondarily to supplement research administrative support to the Business and Administrative Director of CAR.The CHOP/Penn IDDRC is a collaborative research center that advances research into the causes and treatment of intellectual and developmental disabilities. IDDRC researchers focus on an expansive list of research topics including autism, attention-deficit/hyperactivity disorder, behavioral disorders, Cornelia de Lange Syndrome, epilepsy, Friedreich Ataxia, HIV-associated neurocognitive disorders, and leukodystrophies, to name a few. The work of the Center is adjusted when necessary to accommodate new discoveries. The Clinical Research Program Manager's responsibilities for the IDDRC include programmatic oversight, coordination and preparation of competitive renewal applications and annual progress reports with input from Directors of these programs, and monitoring budgetary spending across all Cores in collaboration with Leadership and the Research Business Administrator (RBA).The Center for Autism Research (CAR), a Research Institute Center of Emphasis, conducts a wide range of studies focused on cognitive, social, neuroimaging, and behavioral characterization of autism and related conditions. CAR maintains a robust grant portfolio that supports more than 100 IRB-approved research projects. Under the supervision of CAR's Business and Administrative Director, the Clinical Research Program Manager will help organize outgoing grant submissions for CAR's primary investigators, support the submission of annual progress reports for prime awards and subcontracts, and support CAR PIs in the accurate accounting of their Other Support documents.Successful applicants will have prior experience with federal and non-federal sponsored research grants and be intimately familiar with NIH grant and reporting guidelines. Prior experience with Workday for grants financial management is a plus.This position will require 1 day on-site each week. Additional on-site time may be required under special circumstances. What you will do Supervision, training, support, and management of staff (direct and/or indirect) to ensure compliance with study protocol, NIH and FDA policies. Work collaboratively and effectively with he individual study management teams, various core groups at CHOP's Research Institute and other participating institutions. As part of Management Team, develop, review, and update program policies and procedures as needed. Serve as primary liaison between research and other hospital staff to carry out the needs of the research project(s). Assist with analysis of data and preparation of manuscripts and scientific presentations, as needed. Track regulatory compliance of CHOP and other sites. Oversee financial resources, create internal and external budgets for research protocols, assure financial accountability, and serves as primary liaison between sponsor, department accounting, and Research. Applied knowledge of Good Clinical Practice (GCP) guidelines including protection of human research subjects with particular emphasis on pediatrics, definitions and reporting requirement for adverse events, elements of informed consent, Federal Codes, Regulations and Guidelines relevant to the performance and conduct of clinical trials. Provide supervision and support for other clinical research coordinators and or/ monitors who are assigned to specific protocols and who will help with the overall clinical research of the program. Provide a leadership role in developing, implementing, and evaluating the conduct of clinical research. Responsible for Regulatory compliance for clinical research program. Critically evaluate decisions on staffing, finances, and regulatory needs for the study lifecycle. Additional responsibilities may include Responsible for preparation or overseeing preparation of necessary Data Safety Monitoring Board reports. Serve as the primary contact for trial for internal and external participants.Education Qualifications Bachelor's Degree Required Master's Degree in a related field PreferredExperience Qualifications At least five (5) years of relevant & complex research experience Required At least seven (7) years of relevant & complex research experience Preferred At least one (1) year of leadership, management or supervisory experience Required At least three (3) years of leadership, management or supervisory experience in a clinical research or academic environment Preferred At least three (3) years of research administration or management experience, including budget administration, financial planning, and grants management PreferredSkills and Abilities Excellent verbal and written communications skills Excellent interpersonal skills Excellent customer service skills Excellent time management skills Strong critical thinking / problem-solving skills Strong project management skills Strong organizational skills Strong analytical skills Solid leadership skills Ability to maintain confidentiality and professionalism Ability to work independently with minimal supervision Ability to convey complex or technical information in an easy-to-understand manner Ability to collaborate with stakeholders at all levels Ability to be flexible and adaptable to changeTo carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must be fully vaccinated against COVID-19 and receive an annual influenza vaccine. Learn more.Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed.EEO /