Clinical Research Study Lead - Clinical In Vivo Gene Therapy group (CIGT)

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 does not discriminate on the basis of race, color, sex, national origin, religion, or any other legally protected categories in any employment, training, or vendor decisions or programs. CHOP recognizes the critical importance of a workforce rich in varied backgrounds and experiences and engages in ongoing efforts to achieve that through equally varied and non-discriminatory means.

A Brief Overview

The Clinical In Vivo Gene Therapy group (CIGT) is dedicated to developing and conducting adeno-associated virusgene transfer and molecular therapy trials at Children's Hospital of Philadelphia. Through industry partnerships and investigator-initiatedtrials, CIGT seeks to further the development of transformative human therapies and to build upon CHOP's legacy as a leader in gene therapy research. Led by experts inin vivogene therapy research, with more than 10 years of clinical trial experience, the CIGT team has a wealth of knowledge to navigate the complex safety, regulatory, and clinical care considerations of gene therapy clinical research. Our group offers resources to support the startup and conduct of industry-sponsored trials, as well as regulatory and clinical operations support for CHOP investigator-initiatedclinical trials. The Clinical Research Study Lead is responsible for assisting the CRCs with study start-up and actively dosing and enrolling clinical trials. This role functions autonomously in a clinical research setting and is 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.

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.

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 receive an annual influenza vaccine. Learn more.

EEO / VEVRAA Federal Contractor | Tobacco Statement

SALARY RANGE:

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

-------------------

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.