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Description

Job Summary

Manages the Clinical Trials Unit team who serve Nicklaus Children's Health System community of investigators in partnership with the Director of Research. Oversees the Clinical Research Coordinators (CRC), Data Assistants, and CRC Leads in the department including all CTU-related metrics (screenings, enrollments, workload/bandwidth, productivity, and hiring).          

Job Specific Duties

• Works with the Director and other stakeholders to support the research mission of NCHS. 
• Assist Director in the development and evaluation of goals and objectives that align with the NCHS strategic imperatives and manages the activities to support the implementation of such objectives. 
• Manages the Clinical Trials Unit and staff to include monitoring staff attendance, productivity, and performance markers. Responsible for providing and/or overseeing staff related activities including orienting, ongoing coaching/training, and performance evaluations. 
• Works with the Research Operations Manager and Study Start-Up personnel to evaluate the feasibility of new clinical research studies for successful enrollment at NCHS, including assessment of available patient population, timeline for enrollment, and availability of resources to meet the protocol requirements. 
• Ensures Research Institute Clinical Trial Management System (CTMS) is accurate, up-to-date, and reviewed in accordance with management plans, specifically the study status, research participant enrollment status, and study personnel are accurate and up-to-date.
• Serves as a liaison with investigators, sponsor representatives, and other external entities to facilitate understanding of the Human Research Protection Program (HRPP) and foster compliance with research regulations and policies. 
• Generate and provide accurate and contemporaneous study portfolio and enrollment metrics/reports to leadership and departments/service lines.
• Oversees business development activities for the Clinical Trials Unit and establishes rapport with outside vendors, such as sponsors and CROs, to maintain present business and to generate new business while safeguarding the protection of research participants. 
• Schedules and participates in re-occurring huddles and meetings with Clinical Trials Unit staff to relay important information to the staff and  serve as an open forum for staff feedback and general discussion. 
• Ensures all necessary training is available and provided to the Clinical Trials Unit to maintain AAHRPP accreditation.  
• Identify barriers to quality services, compliance, or ineffective processes as it related to the clinical trials unit staff and their functions. 
• Responsible for CTU employee hiring, promotions, disciplinary actions, and termination in partnership with the Director. 

Qualifications

Minimum Job Requirements

• Bachelor's Degree in Biomedical or Business Management
• Clinical Research Certification (CCRC, CCRP, or CCRA) via SOCRA or ACRP
• 4-7 years of clinical research supervisory/management experience in either an academic hospital engaged in research, university, Clinical Research Organization, or Pharmaceutical/Medical Device company

Knowledge, Skills, and Abilities

• Experience in pediatric clinical research preferred.
• Knowledge of federal regulations governing research.
• Knowledge of the types of clinical research.
• Leadership qualities including problem solving skills.
• Able to relate cooperatively and constructively with clients and co-workers.
• Effectively monitor and develop the abilities of subordinates.
• Possesses strong attention to detail and follow-up skills.
• Ability to communicate effectively both verbally and in writing.
• Ability to use logical thinking to interpret research study protocols and solve a broad range of problems.
• Ability to use analytical skills and provide productivity assessments.
• Ability to interpret, adapt, and react calmly under stressful conditions.
• Able to maintain confidentiality of sensitive information.
  

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