Clinical Research Manager

SHIFT:

Day (United States of America)

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 talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children. We strongly encourage candidates of all races, colors, ethnicities, religions, perspectives, sexes, backgrounds, and lived experiences to apply.

A Brief Overview
This role functions autonomously in a research setting and responsible for the management of research projects which may include multiple moderate to large scale clinical trials or studies. 

Able to perform all aspects of clinical research coordination activities and directly assigned responsibilities as it relates to operationalizing the vision of the Principal Investigator.

Orients and trains staff handling research administration activities associated with conducting complex studies. Identifies adequate coverage for study staff needs, across multiple projects, which 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.
• Supervise the implementation of and adherence to study protocols. Educate research and clinical staff on established policies, processes, and procedures.
• Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
• Interacts directly with investigators.
• Coordinates new protocol, consent forms for single or multiple studies.
• Oversee and coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies.
• Complete annual reports to Institutional Review Board, CTSA, FDA and other regulatory agencies.  Submit Investigational New Drug applications to the FDA as required.
• Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
• Monitor Institutional Review Board submissions, and respond to requests and questions.
• Provide leadership and expertise in identifying and completing research grants.
• Oversee financial resources, create internal and external budgets for research protocols, assure financial accountability, and serves as primary liaison between sponsor, department accounting, and Research.
• Provide oversight for clinical research coordinators who are assigned to project specific protocols and who will help with the overall clinical research of the study team.
• Will directly supervise Project Manager I’s and Clinical Research Coordinators assigned to the project.
• Management Group
• Lead or chair committees or task forces to address and resolve significant issues.
• Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
• Analyze 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.
• Assist with analysis of data and preparation of manuscripts and scientific presentations.
• 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 Preferred

Experience Qualifications

• At least five (5) years of relevant and complex research experience Required
• At least one (1) year of leadership, management or supervisory experience Required
• At least one (1) year of experience leading relevant clinical research projects Required
• At least three (3) years of experience leading relevant clinical research projects Preferred

Skills and Abilities