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Seeking Breakthrough Makers

Children’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 Inclusion

CHOP 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
This role functions autonomously in a clinical research setting and responsible for the management of specific research project(s) which may include multiple small to moderate scale clinical trials and studies.

Able to perform majority of clinical research coordination activities and additional responsibilities as it relates to operationalizing the vision of the Principal Investigator.

Orients & trains staff handling research activities associated with conducting studies. Identifies adequate coverage for study staff needs, potentially across multiple projects, which may vary in administrative complexity.

The Clinic Research Study Lead will be assisting with program development and management of the research program of Dr. Lisa Schwartz. Dr. Lisa Schwartz in the Section of Behavioral Oncology/Center for Childhood Cancer Research at the Children’s Hospital of Philadelphia. Dr. Schwartz is a behavioral scientist/clinical psychologist whose research mostly focuses on disease self-management of adolescents and young adults (AYA) impacted by pediatric chronic illness—especially cancer. This research focus includes health care utilization, health promotion, readiness to transition to adult care and related disparities and multi-level barriers. The research also includes digital health components and intervention studies. Dr. Schwartz is co-director of CHOP’s Mobile Health Research Affinity Group. Dr. Sara King-Dowling, a Research Scientist specializing in pediatric exercise science, is also a key member of the lab who co-leads many studies and provides mentorship. Other key members of the lab include 2 clinical research coordinators, a postdoctoral fellow specializing in research with AYA with sickle cell disease, and part time student trainees.

Research within the lab includes:

· Two multisite R01s related to self-management and follow-up care AYA cancer survivors (longitudinal and intervention studies)

· Mixed methods research on barriers to engagement in follow-up care

· Studies on interventions to educate about and manage pediatric cancer predisposition

· Observational studies on physical activity in cancer using biosensors and ecological momentary assessment.

Job Description:

The Clinical Research Study Lead will assist with a range of tasks related to program development, lab management, and support of clinical research studies.

Possible tasks are related to program development:

· The CRL will coordinate need assessment of CHOP investigators related to conducting multi-level research related to condition management and adherence at CHOP. This includes understanding investigator needs related to implementing rigorous digital and self-report assessment methods (e.g., measuring adherence, self-management skills, health behaviors), intervention designs, partnerships within the health care system and community, addressing disparities, etc.

· Benchmarking resources and programs at peer institutions related to conducing cutting edge research related to managing disease and health promotion, both within cancer control research and beyond

· Coordinate advisory board that includes internal and external members

· Help support self-management investigators at CHOP in terms of coordinating grant reviews, writing seminars, shared datasets, etc.

· Support expansion of Penn-based platform for managing cancer to support research on pediatric disease management among pediatric populations at CHOP.

· Help support Mobile Health Research Affinity group activities.

Possible tasks related to specific clinical research:

· Overseeing trainee onboarding, scheduling, and task management

· Oversight of CHOP IRB submissions and management, including multisite IRB management.

· Provide additional support on ongoing or developing studies with participation in tasks such as writing (grants, papers, other dissemination), intervention design and implementation,

· The CRL will assist with extracting and analysis of electronic health record data. This may include chart review, data extraction, data analysis.

· The CRL will assist with data management, analysis, and preparation of tables, graphs, and manuscripts. This may also include data cleaning and statistical analysis.

· The CRL will be responsible for supervising research assistants and clinical research coordinators. Specifically: The CRL may supervise research assistants and/or clinical research coordinators in the screening, recruitment, and enrollment of eligible participants, during health care encounters or by phone. The CRL will also supervise RAs and CRCs in the conduct of semi-structured interviews, using an interview guide and will assist with qualitative analysis of interview transcripts.

Core Responsibilities:

· Program development tasks related to enhancing and expanding disease/self-management (across pediatrics) and cancer control research.

· Supporting organized collaborative activities of disease/self-management research of investigators (writing groups, mentorship/mentee activities).

· Help lead research team including research assistants and/or clinical research coordinators

· Assist with data collection and recruitment and retention

· Support data cleaning, management, and statistical analysis

· Assist with the preparation of tables, figures, presentations, and manuscripts

· Prepare and adhere to IRB-approved protocols

· Recruit and consent participants, complete semi-structured interviews

· Code and analyze interviews using content analysis

· Create data-collecting tools and manage data using software such as REDcap, SPSS and Dedoose.

· Coordinate research/project team meetings

· Submit documents to regulatory authorities (e.g. IRB) and/or review/monitoring boards (ie, DSMB, independent safety officer)

· Must comply with federal, state, and sponsor policies

· Register and help update studies on ClinicalTrials.gov

What you will do

• Operationalizes study activities and serves as the primary liaison across multiple areas to ensure study success.
• Operates autonomously in support of executing the PI’s mission.
• Supervises the implementation of and adherence to study protocols. Educates research and clinical staff on established policies, processes, and procedures.
• May determine effective strategies for promoting/recruiting research participants and retaining participants in long-term studies.
• Interacts directly with investigators.
• Coordinates new protocol, consent forms for single or multiple studies.
• Coordinates new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies.
• Completes annual reports to Institutional Review Board, CTSA, FDA or other regulatory agencies. Submit Investigational New Drug applications to the FDA as applicable.
• Audits operations, including laboratory procedures if applicable, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
• May include supporting investigators and working on grants submission
• Oversees financial resources, as needed, creates internal and external budgets for research protocols under the supervision and approval of PI, assures financial accountability, and serves as primary liaison between sponsor, department accounting, and Research.
• Provide guidance and support for clinical research coordinators who are assigned to project specific protocols and who will help with the overall clinical research of the study team.
• May have supervisory/lead responsibilities.
• Management Group
• Leads or chairs committees or task forces to address and resolve significant issues.
• Engages in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
• Analyzes trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance.
• Additional responsibilities may include
• Budget development and management
• Effort reporting including complex effort designation, across multiple studies
• Contract review and coordination including working with Supply Chain
• Report development and communication for sponsors
• Responsible for overall management of the trial(s) to ensure compliance with study protocol, FDA, NIH and IRB policies.

Education Qualifications

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

Experience Qualifications

• At least two (2) years of relevant and complex research experience Required
• At least three (3) years of relevant and complex research experience Preferred
• Previous experience with leading clinical research projects Preferred
• Previous leadership, management or supervisory experience Preferred

Skills and Abilities

• Intermediate 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.
• Excellent verbal and written communications skills
• Excellent interpersonal skills
• Excellent time management skills
• Strong organizational skills
• Strong project management skills
• Strong analytical 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 influence others to accomplish tasks outside of the direct span of control

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 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.

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