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

Children’s Hospital of Philadelphia•Philadelphia, PA

22h

About The Position

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 time‑management skills, advanced medical knowledge, and prior experience in a clinical setting.

Requirements

Bachelor's Degree Required
At least five (5) years of relevant & complex research experience Required
At least one (1) year of leadership, management or supervisory experience Required
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

Nice To Haves

Master's Degree in a related field Preferred
At least seven (7) years of relevant & complex research experience Preferred
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

Responsibilities

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.
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.