Clinical Trials Manager

About the role

The Clinical Trials Manager provides strategic planning, growth, and development for Clinical Research conducted in the Delaware Valley. The incumbent supervises and coordinates the responsibilities of research nurses and staff conducting studies and oversees the management of all clinical research projects conducted at Nemours Children’s Hospital- Delaware. Managing both Hematology and Oncology Research Associates, this position will support the Moseley Institute in Delaware Valley. Collaborating with Research partners across multiple Nemours sites and Non-Nemours sites this leadership role will work in conjunction with the enterprise coalition for the Nemours Center for Cancer and Blood Disorders (NCCBD).

Responsibilities

• Meet with the medical staff and faculty on a regular basis to assess their needs pertaining to clinical trials research.
• Develop goals and performance measures in conjunction with the medical faculty to ensure growth and development of the clinical trials program.
• Meet regularly with the Associate Administrator – Delaware to provide feedback on new initiatives, performance of on-going initiatives, and seek feedback for future programmatic development.
• Aid with budget management of the clinical trials program in Delaware Valley.
• Supervise and coordinate the daily activities of the research coordinators and staff.
• Provide guidance and oversight for submissions to scientific and ethical review committees.
• Review new research protocols and ensure there is adequate and appropriate staffing for current and planned protocols.
• Conduct interviews and make hiring recommendations.
• Provide oversight, periodic review including rounding, and feedback to clinical trials staff.
• Provide procedures for systematic record keeping, drug accountability, patient interactions, equipment tracking, and good clinical practices.
• Provide pre-review prior to external audit or investigations.
• Responsible for performance management of designated staff.

Requirements

• Masters degree preferred; Bachelors degree with appropriate experience may be acceptable.
• BSN with active Delaware Nursing License preferred.
• Five years of Clinical Research Coordinator experience or equivalent experience required, with a minimum of 5 years clinical pediatric experience.
• Pediatric Oncology Clinical Research experience preferred.

Qualifications

Essential Functions Strategic Planning and Development: Meet with the medical staff and faculty on a regular basis to assess their needs pertaining to clinical trials research. Develop goals and performance measures in conjunction with the medical faculty to ensure growth and development of the clinical trials program. Meet regularly with the Associate Administrator – Delaware to provide feedback on new initiatives, performance of on-going initiatives, and seek feedback for future programmatic development. Assist with budget management of the clinical trials program in Delaware Valley.

Supervision and Oversight: Supervise and coordinate the daily activities of the research coordinators and staff. Provide guidance and oversight for submissions to scientific and ethical review committees. Review new research protocols and ensure there is adequate and appropriate staffing for current and planned protocols. Conduct interviews and make hiring recommendations. Provide oversight, periodic review including rounding, and feedback to clinical trials staff. Provide procedures for systematic record keeping, drug accountability, patient interactions, equipment tracking, and good clinical practices. Provide pre-review prior to external audit or investigations. Responsible for performance management of designated staff.