Director, Clinical & Research Operations

The Director, Clinical & Research Operations will collaborate with the Director, Research Administration, Primary Investigators (PI), and designated study staff to coordinate all clinical research activities for each project. Provides oversight of all clinical operations related to research study projects. This role reports to CHKD Clinical Research Institute senior leadership (currently Chair, Department of Pediatrics / Chief Clinical Academic Officer, Children's Hospital of The King's Daughters).

• Program Administration
  • Determine administrative feasibility of new protocols.
  • Implement pre-initiation activities such as establishing timelines for conducting and completing clinical trials, clarifying protocol issues with sponsors, acting as a liaison between the Clinical Research Institute and study sponsors, and making initial contact with potential PIs and/or sub-investigators to collaborate on projects.
  • Maintain up-to-date knowledge of regulatory requirements and GCP standards.
• Administrative Operations
  • Coordinate with the Director of Clinical Research Administration to prepare and submit documentation to the institutional review board and other committees as required.
  • Ensure regulatory staff make timely administrative submissions to the IRB and other committees as appropriate.
  • Assist pediatric and faculty and other research staff with regulatory submissions by reviewing, guiding, and providing required documents.
  • Facilitate and attend meetings regularly to discuss updates, issues, and/or concerns regarding projects.
• Clinical Operations
  • Oversee all clinical functions related to research activities.
  • Provide coordination of space and equipment required by clinical trial activities.
  • Supervise Clinical Research Associates (CRC) and Clinical Research Coordinator (CRA) in components related to recruitment study, visits, and documentation.
  • Monitor enrollment goals and perform administrative tasks arising from the PI’s recruitment plan.
  • Assist CRCs/CRAs with problem-solving/form development as needed in the conduct of clinical trials.
  • Coordinate with Laboratory and Pharmacy staff regarding requirements of clinical research activities.
• Quality Management
  • Develop, implement, and maintain quality assurance standards and measures.
  • Keep informed of current trends in clinical research and regulatory requirements.
  • Maintain a customer-focused environment for providers and consumers to monitor feedback.
  • Investigate and respond timely to all customer complaints.
  • Assist with preparation of study budgets.
  • Maintain communication regarding study status and expenses.
  • Work with the financial manager on study-related issues.
• Leadership
  • Supervise orientation and training on new CRCs and other study staff.
  • Provide staff with clear expectations of service levels.
  • Leads, manages, coaches, and trains a team or department, provides guidance, support, and mentors to ensure optimal performance and productivity.
  • Oversees the recruitment, hiring, team/department orientation, performance appraisals and disciplinary actions including up to termination processes for a team or department.
• Performs all other duties as assigned.

• Required Licenses and/or Certifications None required.
• Preferred Licenses and/or Certifications None preferred.

• Required Education and Experience
  • Bachelor’s degree in healthcare administration or a health related or business-related field is required.
  • Three years of health care experience required.
  • Three years of management experience required.
  • Five years of progressive leadership experience in research administration required.
• Preferred Education and Experience None preferred.

• Demonstrated professional knowledge of areas of research and practice administration.
• Excellent verbal and written skills.

• Normal office environment with little exposure to excessive noise, dust, temperature and the like.

• to view physical requirements.