Clinical Research Program Manager I - Very Early Onset (VEO) Inflammatory Bowel Disease

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A Brief Overview

The Very Early Onset (VEO) Inflammatory Bowel Disease Research Program Manager will join a highly collaborative and high performing team dedicated to uncovering the genetic and immunologic drivers of VEO-IBD and advancing targeted therapeutic approaches.

This management role entails providing clinical organizational support for the research in the VEO Program, directed by Judith Kelsen, MD. Our multidisciplinary translational program includes experts in immunology, genetics, bioinformatics, pathology and basic science biology who are highly collaborative and innovative using cutting edge technologies to develop an individualized and targeted therapies to help improve our patients' quality of life.

We are seeking a full-time clinical research program manager who works closely with the clinical care team as well as the clinical and laboratory research teams. This is a unique career opportunity to be part of a large prospective translational research program that includes a large patient registry and biorepository and collaborations that span CHOP, the University of Pennsylvania and many national and international collaborators. Responsibilities include, but are not limited to, organizing the recruitment of research participants, interfacing with clinical care and lab staff to schedule research visits, ensuring adherence to study protocols, preparing and submitting regulatory documentation to the Institutional Review Board, developing and maintaining accurate clinical study databases, collaborating with laboratory teams, and supervising clinical research coordinators. The ideal candidate is an exceptional communicator with strong organizational and timemanagement skills, advanced medical knowledge, and prior experience in a clinical setting.

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, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine. 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.