Reference #: 1014809
SHIFT:Day (United States of America)Seeking Breakthrough MakersChildren'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's Commitment to Diversity, Equity, and InclusionCHOP is committed to building an inclusive culture where employees feel a sense of belonging, connection, and community within their workplace. We are a team dedicated to fostering an environment that allows for all to be their authentic selves. We are focused on attracting, cultivating, and retaining diverse talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children.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 ma uscripts 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 internal and external participants.Education Qualifications
Bachelor's Degree Required
Master's Degree in a related field PreferredExperience Qualifications
At least five (5) years of relevant & complex research experience Required
At least seven (7) years of relevant & complex research experience Preferred
At least one (1) year of leadership, management or supervisory experience Required
At least three (3) years of leadership, management or supervisory experience in a clinical research or academic environment Preferred
At least three (3) years of research administration or management experience, including budget administration, financial planning, and grants management PreferredSkills 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
Strong project management skills
Strong organizational skills
Strong analytical skills
Solid 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 changeTo carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must be fully vaccinated against COVID-19 and receive an annual influenza vaccine. Learn more.Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed.EEO / VEVRAA Federal Contractor | Tobacco StatementChildren'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.