Clinical Research Program Manager I - Center for Fetal Diagnosis and Treatment

SHIFT:

Day (United States of America)

Seeking Breakthrough Makers

Children’s Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation.

At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care—and your career.



CHOP does not discriminate on the basis of race, color, sex, national origin, religion, or any other legally protected categories in any employment, training, or vendor decisions or programs. CHOP recognizes the critical importance of a workforce rich in varied backgrounds and experiences and engages in ongoing efforts to achieve that through equally varied and non-discriminatory means.


A Brief Overview
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.

About the Department

Clinical Outcomes Data Archive (CODA) is seeking a hands‑on Clinical Research Project Manager with strong project‑management skills to keep our data‑driven studies running smoothly—on time, on budget, and at the highest level of excellence. 

The recent integration of generative AI into CODA workflows presents a significant opportunity to generate meaningful insights more efficiently than ever before. This transition requires careful deployment, testing, and ongoing monitoring—activities that this role will directly support.  Importantly, risk-adjusted outcomes data generated through CODA are vital for patient counseling, care decisions, and translational research. Our team publishes key findings that drive national referrals of patients who begin their CHOP journey before birth.

The ideal candidate will have a master's degree in a related field.

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.
• Critically evaluate decisions on staffing, finances, and regulatory needs for the study lifecycle.
• Additional responsibilities may include
• Responsible for preparation or overseeing preparation of necessary Data Safety Monitoring Board reports.
• Serve as the primary contact for trial for i