Clinical Research Program Manager - Neonatology

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A Brief Overview

The Clinical Research Program Manager I will partner closely with the Principal Investigator to ensure smooth operations of multiple complex neonatal clinical research studies. They will oversee the daily operations of the investigator's clinical research portfolio. The portfolio includes toddler and school-age neurodevelopmental outcome studies conducted in high-risk, preterm populations, neonatal clinical trials, and multicenter, multimodal, longitudinal, studies of high risk, term born infant populations. Responsibilities specifically include deep understanding and oversight of research related funds flow; participation in grant writing including budget preparation, document formatting and editing, and maintaining up to date biosketch, other support, and facilities pages; preparation of NIH or similar progress reports, including budgets and detailed progress updates; development and oversight of research related quality control measures; facilitation of manuscript preparation and submission including, but not limited to literature review and reference management; and assistance, hiring, training, and participating in management of research assistants and coordinators.

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 internal and external participants.

Education Qualifications

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

Experience 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 - 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
• 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 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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SALARY RANGE:

Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.

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At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.