Research Administrator 3 / Pediatrics Clinical Research Operations Manager

The mission of Pediatrics Clinical Research Management is to support the conduct of clinical research aimed at improving the health and well-being of infants, children, adolescents, and their families by applying innovative strategies for prevention, early detection, diagnosis, and treatment of pediatric conditions. Support is provided through proactive, high-quality, and efficient study management in compliance with federal regulations and local policies and procedures. This fast-paced and dynamic research environment involves complex clinical research studies within a vulnerable pediatric population. This position is responsible for managing key components of clinical trial conduct in accordance with Good Clinical Practice, and for tracking and ensuring compliance with clinical trial performance benchmarks, patient safety standards, staff development and training, and financial goals.

The Pediatrics Clinical Research Operations Manager is responsible for direct oversight of clinical research activities within their designated Pediatric clinical research program(s).  Their responsibilities may include personnel management for employees in the clinical research organization, and/or management of finances associated with clinical research accounts and overall program budget, and/or program development in collaboration with program directors and investigators.  In support of these activities, the Pediatrics Clinical Research Operations Manager is involved in continual process improvement to further the efficiency and effectiveness of the clinical research organization. 

The Pediatrics Clinical Research Operations Manager is responsible for facilitating a caring and compassionate patient-focused experience and serves as a liaison between investigators and external sponsors as well as other stakeholders within the institution.

• PhD in related field plus 8 years of relevant experience or Master and 10 years of experience.
• Strong understanding of clinical research requirements with regard to staffing, systems and processes.
• Ability to lead a group, serve as a mentor and/or facilitator, and create a positive work environment.
• Ability to ensure and deliver a customer service orientation that translates into timely and reliable support to staff, investigators, sponsor partners and other customers.
• Ability to set appropriate priorities and manage time.
• Excellent communication skills; ability to express and document ideas clearly and concisely in written communications; able to champion personal perspective while maintaining the ability to listen, comprehend, and adjust, when required, to other points of view.
• Self-starter with ability to work independently but collaboratively as part of a team.
• Strong critical thinking skills, problem-solving abilities, organizational skills and multi-tasking capabilities.
• Energy and drive to coordinate multiple projects simultaneously.
• Solution-oriented approach to issues.
• Ability to use tact and diplomacy to maintain effective working relationships.
• Proficiency in Microsoft Office programs (Word, Excel, and PowerPoint).

• Experience to include at least 3 years clinical research experience AND at least 1 year supervisory or lead work experience.
• Deep knowledge and experience with FDA, ICH GCP and other regulatory guidelines that govern clinical research.
• Working knowledge of OnCore, EPIC, and/or Oracle.
• Clinical research certification (SoCRA, ACRP).