Clinical Research Program Manager - Chan Lab

SHIFT:

Day (United States of America)

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We strongly encourage all candidates of diverse backgrounds and lived experiences to apply.


A Brief Overview

The Chan Lab at the University of Pennsylvania's Perelman School of Medicine is dedicated to advancing the survival and health of mothers, newborns, and children. Our research focuses on improving health outcomes in low-resource settings, particularly in the prevention and management of preterm and small babies, neonatal infections, and optimizing growth and development. The primary goal of our research program is to design, test, and scale interventions that prevent morbidity and early mortality among mothers and children worldwide.

The Clinical Research Program Manager (CRPM) will provide senior oversight and management of the research program and projects within the Chan Lab. This portfolio includes a broad range of initiatives, such as multi-country clinical trials, epidemiologic cohort studies, and innovations in technology and data science. Our research is conducted primarily in international settings and involves collaboration with multiple global partners and stakeholders.

The CRPM will oversee research grants, personnel, trainees, and laboratory operations, ensuring smooth operations, timely achievement of milestones, and successful delivery of project outcomes. They will manage regulatory submissions and oversight of Data Use Agreements, Material Transfer Agreements, and other Agreements. The CRPM will also be responsible for budgeting and financial management and will play a critical role in shaping the future vision of the program by participating in grant development and writing. The CRPM will be expected to also be responsible for the preparation, submission, and presentation of progress reports for donors, sponsors, the IRB, and other stakeholders.

This position requires technical expertise and experience to operationalize, mentor, and guide team members through the entire study lifecycle, from conception through execution and termination. Ability to perform all clinical research coordination activities and additional oversight responsibilities as required.

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 the 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.
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