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Clinical Research Project Mgr I - 65012

Philadelphia, PA, US, 19104

Job Type: 

LOC_ROBERTS-Roberts Ctr Pediatric Research Req ID: 82631

Shift: Days

Employment Status: Regular - Full Time 

Job Summary

 

The PEDSnet Project Manager will join an internationally recognized group at the Children’s Hospital of Philadelphia working to transform the health of children. He or she will work within a dynamic team of data scientists, programmers, and researchers as part of PEDSnet (https://www.pedsnet.org) and the Research Institute’s Applied Clinical Research Center, to understand predictors of childhood diseases, improve the quality of children’s healthcare, and rapidly advance knowledge through the creation and development of learning health systems.


Under the direction of the Operations Director, the Project Manager will be responsible for managing individual PEDSnet research projects- working with the study team to create and monitor project timelines, ensuring all regulatory and contractual agreements are in place, ensuring all project deliverables are met, and updating project status and tasks in the PEDSnet project management system. The Project Manager will be a part of the PEDSnet Project Management Office (PMO) and will work with the Operations Director and other Project Managers to create processes, systems, and procedures for managing PEDSnet project, operational, and governance activities.  

 

The Project Manager will also participate in PEDSnet Operations and Governance work, such as managing the PEDSnet Steering Committee, managing the new institutional member onboarding process, and managing network sustainability and strategic relationships under the supervision of the Center Director, Dr. Forrest.

Job Responsibilities
  1. Construct and maintain project plans for operational tasks, data requests, and research projects, including incremental deliverables and resource requirements. Coordinate tasks across multiple sites based on project plans.
  2. Work with the Operations Director and other PMO members to create network and study specific reports and dashboards on status and overall resource allocation.
  3. Work in conjunction with DCC and PEDSnet leadership, and the PEDSnet program management office (PMO) to develop efficient workflows for operational, research, and project-specific data tasks, including creation of new processes, procedures, and systems to manage workflow.
  4. Collaborate with PEDSnet Coordinating Center staff to execute complex projects across technical, regulatory, and scientific domains. This includes preparing and processing regulatory and institutional submissions to support data governance processes and ensure fidelity to data privacy standards within the DCC.
  5. Manage communications and ensure timely follow up on action items both within the PMO, DCC and across participating sites.
Job Responsibilities (Continued)
  • Supervise the implementation of and adherence to study protocols. Educate research and clinical staff on established policies, processes, and procedures.
  • Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
  • Develop consent forms for approval by Human Subjects Panel.
  • Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. 
  • Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies.  Submit Investigational New Drug applications to the FDA as required.
  • Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
  • Monitor Institutional Review Board submissions, and respond to requests and questions.
  • Provide leadership and expertise in identifying and completing research grants.
  • 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.
  • Provide guidance and support 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 have minimal supervisory responsibilities. 

 

Management Group

  • Lead or chair committees or task forces to address and resolve significant issues.
  • Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
  • Analyze 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.
  • Assist with analysis of data and preparation of manuscripts and scientific presentations.
Job Responsibilities (Continued)
Required Licenses, Certifications, Registrations
Required Education and Experience

Required Education: Bachelor’s degree
 

Required Experience: Three (3) years relevant clinical research experience

Preferred Education, Experience & Cert/Lic

Preferred Education: Master’s degree

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.

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 

Talent Acquisition

2716 South Street, 6th Floor

Philadelphia, PA 19146 

 

 

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