Clinical Research Program Manager - The Chan Lab

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A Brief Overview

The successful candidate will join the team of Dr. Grace Chan at Children's Hospital of Philadelphia. The Chan Lab 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 II at the Chan Lab is responsible for overseeing and managing a diverse portfolio of clinical and population health research projects aimed at improving health outcomes for mothers, newborns, and children, particularly in low-resource settings. This role involves managing multi-country clinical trials, epidemiologic studies, and collaborations with global partners; ensuring compliance with regulatory standards; and providing leadership and mentorship to research staff. It is anticipated that the CRPM will make multiple trips to Ethiopia to oversee the conduct of a clinical trial and meet with collaborators.

The CRPM will be responsible for grant writing, financial management, and the preparation of reports for various stakeholders and should have experience in these areas. The ideal candidate will also have outstanding communication and relationship skills and experience with international public health research, project and program administration, and staff supervision. Additionally, the ability to be agile, assess the environment, and develop new programs is essential. The CRPM must also support and lead existing programs in reporting outcomes and activities in collaboration with key global health stakeholders.

The expected breakdown of responsibilities would be as follows:

40% grant writing

40% program management (including clinical trial)

10% publication support (contributing to writing, submissions, coordinating co-authors)

10% communications - CHOP and external

What you will do

• Direct and indirect supervision, training, support, and management of staff 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 clinical trial budget preparations and billing plans and resolution of billing/budget issues.
• 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.
• Provides 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.
• Primary contact for trial for internal and external participants.

Education Qualifications

• Bachelor's Degree Required
• Master's Degree in a related field Preferred

Experience Qualifications

• At least eight (8) years of relevant & complex research experience - Required
• At least three (3) years of research administration or management experience, including budget administration, financial planning, and grants management - Required
• At least three (3) years of leadership, management or supervisory experience - Required
• At least ten (10) years of relevant & complex research experience - Preferred
• At least five (5) years of research administration or management experience, including budget administration, financial planning, and grants management - Preferred
• At least five (5) years of leadership, management or supervisory experience in a clinical research or academic environment - Preferred

Skills and Abilities

• Excellent verbal and written communications skills
• Excellent interpersonal skills
• Excellent customer service skills
• Excellent time management skills
• Strong critical thinking / problem-solving skills
• Excellent project management skills
• Excellent organizational skills
• Excellent analytical skills
• Strong leadership skills
• Ability to maintain confidentiality and professionalism
• Ability to work independently with minimal supervision
• Ability to convey complex or technical information in an easy-to-understand manner
• Ability to collaborate with stakeholders at all levels
• Ability to be flexible and adaptable to change

To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, professionals working onsite-at any CHOP location, for any portion of time-must be vaccinated for COVID-19. Learn more.

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