Clinical Research Quality Coordinator (Full Time, Day shift)
Nicklaus Children’s Health System
Location: Miami, Florida
Internal Number: 25542
The Clinical Research Quality Coordinator ensures research compliance of NCH study regulatory submissions, including AAHRPP, FDA, IATA, Citi Training and GCP/ICH. Serves as a subject-matter expert for the research team on relevant laws, regulations, and best practices. Ensures quality goals, including accuracy and timeliness of documentation completion and/or submission are achieved. Monitors internal/external audits independently or with minimal supervision.
Job Specific Duties
Ensure research compliance at NCH study regulatory submissions, including AAHRPP, FDA, IATA, Citi Training and GCP/ICH.
Serve as a subject-matter expert for the research team on relevant laws, regulations and best practices.
Responsible for all aspects of study monitoring including routine monitoring and close-out.
Conducts routine facility visits and builds rapport with clinical and research staff.
Ensures quality goals, including correctness, accuracy and timeliness of documentation completion and/or submission are achieved.
Provides compliance direction and ensures NCH research policies and SOPs are harmonized with relevant rules, regulations, quality standards and good clinical practices.
Monitors internal and external research environment and coordinates the translation of new legislation and regulatory requirements into practice at NCH.
Routine monitoring of ICF's, data integrity, EMR's, and regulatory documents for completeness, accuracy, and compliance.
Ensure staff maintain protocol compliance and proper steps to ensure patient safety.
Analyze monitoring findings and assign major/minor violations, rating the findings, and completing a final monitoring report, including CAPA's for review and approval.
Assembles and provides process improvement based on monitoring findings as applicable.
Collects, maintains and reports data on regulatory and clinical compliance as required.
Minimum Job Requirements
Bachelor's Degree BSN, Bachelor in Sciences or Education
ACRP - Assc Cln Research Professional ACPR, SOCRA or Healthcare Research
1-3 years Clinical Research and/or monitoring or auditing.
Knowledge, Skills, and Abilities
Knowledge of rules and regulations governing research.
Knowledge in the human subject research including GCP and all applicable regulations.
Experience in early phase and medical device experience a plus.
Ability to relate cooperatively and constructively with coworkers, potential and actual investigators and research staff.
Ability to communicate effectively in English, both verbally and in writing.
Ability to maintain confidentiality of sensitive information.
Ability to set and effectively communicate priorities in a changing environment.
Ability to respond calmly under stressful conditions.
Ability to use complex mathematical techniques to budget and provide productivity assessments.
Ability to use logical and scientific thinking to interpret technical data and solve a broad range of problems.
Primary Location :
Florida-Miami-Nicklaus Children's Hospital - Main Hospital Campus
Nicklaus Children’s Health System, is the region’s only healthcare system exclusively for children. In addition to Nicklaus Children’s Hospital and a growing number of outpatient centers located throughout the tri-county area, the health system includes Nicklaus Children’s Hospital Foundation, the organization’s fundraising arm; Nicklaus Children's Pediatric Specialists, a nonprofit physician practice subsidiary; a management services organization, and an ambulatory surgery center. Our vision is to be where the children are. Ultimately, this means being there through all stages of health and life, both physically and emotionally. To be a trusted partner to children and their families, not only in times of illness, but throughout their life journey. Our mission is to inspire hope and promote lifelong health by providing the best care to every child.