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Clinical Research Project Manger I - PEDSnet

Philadelphia, PA, US, 19146

Location: LOC_ROBERTS-Roberts Ctr Pediatric Research 

Req ID: 137357

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.


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 work closely with the Center Director to oversee PEDSnet Operations and Governance work, manage the PEDSnet Research and Steering committees, manage the new institutional member onboarding process, and create and update PEDSnet governance policies on an annual basis.

Job Responsibilities

  • 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. 

Required Education and Experience

Required Education: Bachelor’s degree

 

Required Experience: Two (2) years of relevant clinical research experience

Preferred Education, Experience & Cert/Lic

Preferred Education: Master’s degree in related field

 

Preferred Experience: Three (3) years of relevant clinical research experience

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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