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

Children’s Hospital of Philadelphia•Philadelphia, PA

About The Position

The Clinical In Vivo Gene Therapy group (CIGT) is dedicated to developing and conducting adeno-associated virus gene transfer and molecular therapy trials at Children’s Hospital of Philadelphia. Through industry partnerships and investigator-initiated trials, 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 in in vivo gene 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-initiated clinical 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.

Requirements

Bachelor's Degree - Required
At least two (2) years of relevant and complex research experience - Required
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

Nice To Haves

Master's Degree in a related field - Preferred
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

Responsibilities

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.
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.
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.