The Division of General, Thoracic and Fetal Surgery is seeking a clinical research manager with experience coordinating research studies, clinical trials and IRB processes and procedures. The research project manager plays a key leadership role in various clinical outcomes projects of the Center for Fetal Diagnosis and Treatment and General Surgery working directly with Principle Investigators.
The Center for Fetal Diagnosis and Treatment at The Children's Hospital of Philadelphia is an internationally recognized leader in fetal diagnosis, fetal surgery and fetal care. Since 1995, we have cared for more than 20,000 expectant parents from around the world and performed more than 1,500 fetal surgeries, more than any other program in the world.
Our Center is led by N. Scott Adzick, M.D., M.M.M., a pioneer in the field of fetal medicine who has devoted more than 30 years to groundbreaking work in the field of fetology. We are one of only a few programs worldwide to offer comprehensive prenatal diagnosis, fetal therapy and the option of delivering at a leading pediatric hospital. Our Garbose Family Special Delivery Unit (SDU), the world’s first birth facility exclusively for healthy mothers carrying babies with known birth defects within a children’s hospital, has delivered more than 3,000 babies since it opened in 2008. Babies delivered in the SDU are cared for in our world leading surgical neonatal and infant intensive care unit (NI/ICU) by dedicated specialists.
Our experienced, multidisciplinary team includes maternal-fetal medicine specialists, reproductive geneticists, obstetricians, neonatologists, fetal-neonatal pediatric surgeons, anesthesiologists, fetal imaging specialists, fetal cardiologists, genetic counselors, advanced practice nurses, social workers and psychologists. This team sees rare, complex anomalies every day and cares for these patients from prenatal diagnosis through
Supervises the implementation of and adherence to study protocols. Educates research and clinical staff on established policies, processes, and procedures.
Determines effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
Develops consent forms for approval by Human Subjects Panel.
Oversees and/or coordinates new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies.
Completes annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational Device Exemption (IDE), and Investigational New Drug (IND) applications to the FDA as required.
Audits operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
Monitors Institutional Review Board submissions, and responds to requests and questions.
Provides leadership and expertise in identifying and completing research grants.
Oversees financial resources, as needed, creates internal and external budgets for research protocols, assures financial accountability, and serves as primary liaison between sponsor, department accounting, and research finance
Provides oversight for clinical research coordinators who are assigned to project specific protocols and who will help with the overall clinical research of the study team.
Will directly supervise Project Manager I’s and Clinical Research Coordinators assigned to the project.
Leads or chairs committees or task forces to address and resolve significant issues.
Engages in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
Analyzes trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance.
Assists with analysis of data and preparation of manuscripts and scientific presentations.