Clinical Research Study Lead - Cancer Predisposition

SHIFT:

Day (United States of America)

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A Brief Overview
Under the supervision of Principal Investigator, Dr. Suzanne MacFarland, and Center for Childhood Cancer Research leadership, this role functions autonomously in a clinical research setting and responsible for the management and leadership of research projects on the Cancer Center Predisposition Research Team. These projects include multiple small to moderate scale
clinical trials and biospecimen studies, as well as a multisite network consortia study, which CHOP will lead.

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, across multiple projects and external sites, which may vary in administrative complexity. This will be a hybrid position allowing for remote work 1-2 days a week

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 comp