Clinical Research Study Lead

SHIFT:

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

Brief Project Summary: The successful candidate will join a dynamic research team at the Children's Hospital of Philadelphia (CHOP) and the University of Pennsylvania, which seek to advance the care of patients with special healthcare needs and their families through improving parent-clinician communication systems. The candidate will be responsible for supporting three researchers.

The primary research project, under the supervision of Dr. Katharine Press Callahan, MD, MSME, (50% of time/effort) focuses on re-imagining the consent process for genetic testing in critically ill infants, so that the process will be more in line with parent's needs. This project is funded by a K01 award from the National Human Genome Research Institute. The candidate will also support a smaller project which aims to evaluate how accurately genetic information can be used to prognosticate through medical record review.

The secondary project, under the supervision of Dr. Jackelyn Boyden, PhD, MPH, RN, (25% of time/effort) seek to improve support for families caring for children living with serious illness at home and receiving palliative care through enhancing communication between families at home and their hospital-based pediatric palliative care team. This project is funded by the National Institute of Nursing Research (K23) and the Cambia Health Foundation (Sojourns Scholar Leadership Program).

The third project, under the supervision of Dr. Rebecca Mueller, PhD, LCGC (25% of time/effort), focuses on assessing how adults with childhood-onset genetic conditions understand and communicate with their clinicians about disease prognosis, new treatments, and life-planning to enhance psychosocial support for these patient populations. This project is funded by a K01 award from the National Human Genome Research Institute.

Description of Role: The successful candidate will collaborate with each Principal Investigator (PI) to implement procedures and processes of study implementation, ensuring smooth day-to-day operations. Key responsibilities include:

• Study operations: Managing meeting minutes, preparing and submitting IRB documentation, and preparing ongoing study reports.
• Community engagement: Supporting parent advisory board meetings, including preparation, monitoring attendance, and writing up meeting summaries.
• Data collection and data management: Overseeing participant recruitment, data collection via surveys, interviews, chart review, and follow-up; maintaining data management systems. May also include data collection through medical
• Data analysis and dissemination: Contributing to both quantitative and qualitative analyses. Contributing to writing manuscripts and preparing conference presentations as desired.

Ideal candidates will be self-motivated, able to work well independently and on a research team, and detail-oriented, with excellent time management skills. A strong commitment to working with families of children with special healthcare needs is essential.

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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