"Director of Clinical Research Operations, CCRU"

Director of Clinical Research Operations, CCRU

Job Profile Title: Director C, Research, Clinical

Job Description Summary: The Director of Clinical Research Operations for Cardiology leads all aspects of the Cardiology Clinical Research Unit (CCRU), overseeing clinical trial operations, regulatory compliance, research staff, and strategic program development across Penn Medicine. This role partners with faculty, sponsors, and administrative leadership to expand the research enterprise across cardiology and ensure excellence in trial conduct and participant care. The Director serves as a key member of the cardiology research leadership team and drives initiatives to optimize workflow, quality, and growth.

This position is contingent upon favorable funding.

Job Responsibilities

• Leadership & Workforce Management
  • Lead CCRU clinical research personnel including hiring, onboarding, training, mentoring, and performance management.
  • Manage research pods across cardiology to ensure consistency in clinical trial execution and documentation standards.
  • Support development of project managers, supervisors, and coordinators; set expectations and promote engagement.
  • Lead cross-functional meetings and foster a strong team culture.
• Clinical Operations Oversight
  • Oversee end-to-end clinical trial operations including feasibility, site activation, conduct, monitoring, and close-out.
  • Ensure efficient workflows, documentation accuracy, participant safety, and real-time issue resolution.
  • Standardize operational processes across cardiology sites within Penn Medicine.
  • Allocate resources and staffing across studies to meet enrollment and performance goals.
• Regulatory & Quality Management
  • Oversee regulatory submissions and ongoing compliance for sponsored and investigator-initiated trials.
  • Ensure strict adherence to GCP, FDA regulations, IRB requirements, and institutional SOPs.
  • Provide guidance on protocol development, IRB planning, safety considerations, and ethical research conduct.
  • Lead data quality systems, monitoring plans, and quality assurance initiatives.
• Financial & Administrative Oversight
  • Support the development of study budgets and financial projections.
  • Partner with centralized finance teams on billing plans, coverage analysis, and financial stewardship.
  • Participate in contract negotiations, space planning, and infrastructure development.
• Strategic Planning & Program Development
  • Develop and implement programmatic initiatives to strengthen and expand cardiology research operations.
  • Serve as a key member of the cardiology research leadership team.
  • Foster internal and external collaborations to broaden the CCRU's research footprint.
  • Identify opportunities to enhance operational effectiveness and align with institutional strategy.
• Other duties and responsibilities as assigned

Qualifications

• Bachelor of Arts, Bachelor of Science, and 7 to 10 years of experience or equivalent combination of education and experience is required.

Job Location - City, State: Philadelphia, Pennsylvania

Department / School: Perelman School of Medicine

Pay Range: $105,500.00 - $159,000.00 Annual Rate

To apply, visit: https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Perelman-Center-FL11/Director-of-Clinical-Research-Operations--CCRU_JR00114914