Clinical Research Program Manager

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 Center for Microbial Medicine, a new Center of Emphasis at CHOP, is seeking an experienced Clinical Research Program Manager I to support the Clinical Trials Division under the leadership of Dr. Nikhil Pai. CMM will be dedicated to finding cures and improving pediatric health through the lens of the microbiome. The CHOP Center for Microbial Medicine will focus on developing microbiome-informed clinical diagnostics and microbiomebased therapeutics. The Center will function as a hub for microbiome data partnerships and a conduit for microbiome-based clinical trials. The vision for this center is to introduce novel microbiome-based interventions that will have transformative effects on pediatric health. This role functions autonomously in a research setting and responsible for overseeing all research studies for a particular program for multiple PIs. Provides leadership and ensures implementation of study activities and site management for CHOP and all other participating study sites. Will supervise staff. 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. This role will serve as primary liaison between research and other hospital staff to carry out the needs of the research project(s), including supporting the development of: contractual agreements, and research funding applications and facilitating CHOP Institutional Review Board (IRB) applications.

This role functions autonomously in a research setting and responsible for overseeing all research studies for a particular program for multiple PIs.

Provides leadership and ensures implementation of study activities and site management for CHOP and all other participating study sites. Will supervise staff.

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 clinic