Req ID: 18771
Employment Status: AF – Active – Regular – Full Time
The Project Manager position offers the opportunity to join a dynamic team in the Division of General Pediatrics focused on improving the care of hospitalized children. The position primarily entails managing a 2-year 40-site observational study funded by NHLBI. The position will initially be focused on obtaining regulatory approvals (reliance agreements using SMART IRB, data use agreements, etc), and over the course of the study transitioning to overseeing and monitoring data collection, and participating in the development of a grant application for a follow-up 5-year implementation science hybrid clinical trial. Experience managing regulatory and project management tasks for multicenter studies of at least 10 sites is required.
Orients and trains staff handling research administration activities associated with conducting clinical trials of varying complexities. Monitors service and staffing levels, and identifies adequate coverage for trial workload across one or more teams of study coordinators.
– 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 New Drug 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.
– 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.
– May 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.
Required Education and Experience
Required Education: BA/BS in related field.
Required Experience: 5+ years of relevant clinical research experience; prior experience leading clinical research projects.
Preferred Education, Experience & Cert/Lic
Preferred Education: MA/MS in related field.
Preferred Experience: 3+ years leading relevant clinical research projects.
Additional Technical Requirements
– Responsible for overall management of the trial(s) to ensure compliance with study protocol, FDA, NIH and IRB policies.
– 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.
All CHOP employees who work in a patient building or who provide patient care are required to receive an annual influenza vaccine unless they are granted a medical or religious exemption.
Children’s Hospital of Philadelphia is committed to providing a safe and healthy environment for its patients, family members, visitors and employees. In an effort to achieve this goal, employment at Children’s Hospital of Philadelphia, other than for positions with regularly scheduled hours in New Jersey, is contingent upon an attestation that the job applicant does not use tobacco products or nicotine in any form and a negative nicotine screen (the latter occurs after a job offer).
Children’s Hospital of Philadelphia is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability or protected veteran status.
VEVRAA Federal Contractor/Seeking priority referrals for protected veterans. Please contact our hiring official with any referrals or questions.
CHOP Careers Contact
2716 South Street, 6th Floor
Philadelphia, PA 19146
Email:[Click Here to Email Your Resum]
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Job ID: US*213_*********
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Children’s Hospital of Philadelphia
Since its start in 1855 as the nation’s first hospital devoted exclusively to caring for children, The Children’s Hospital of Philadelphia has been the birthplace for many dramatic firsts in pediatric medicine. The Hospital has fostered medical discoveries and innovations that have improved pediatric healthcare and saved countless children’s lives. Contact Info
– Philadelphia, PA 19146
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