Compliance Coordinator - Pediatrics Endocrine & Diabetes

The UI Stead Family Department of Pediatrics, Division of Endocrine & Diabetes is seeking a Compliance Coordinator to coordinate and manage clinical trial regulatory activities within the Clinical Research services.  

Duties to include: 

• Responsible for opening, maintaining, and closing clinical trials: provide leadership, oversight and management of multiple complex clinical studies
• Coordinate specific aspects of external review and internal processes. Specifically, oversee the preparation and submission of the appropriate Human Subjects Review forms and application materials to the Institutional Review Board (IRB-01), Institutional Review Board (IRB-03) as appropriate, central IRB entities; prepare consent forms for research protocols and local and central IRB submissions.
• Prepare and submit application forms and serve as liaison to the Clinical Research Unit (CRU), the Pharmacy and Therapeutics Committee, the Medical Radiation Protection Committee, the Protocol Review and Monitoring Committee, Joint Office of Compliance, Nursing Research Committee, Pathology Committee, and other review committees when necessary. Perform preliminary investigation and analysis, including basic comparison of practice to regulations across teams.
• Responsible for the preparation and submission of documents related to research protocol annual reviews, modifications, Adverse Events, Safety Reports and other reportable events to IRB as needed; manage all regulatory requests to sponsors and detailed letters of correspondence to the IRB.
• Responsible for regulatory process and document preparation used in the implementation and maintenance of clinical trials sponsored by industry, national agencies, consortia, and cooperative
• Analyze and prepare data/reports as needed, and serve as liaison to clinicians, research investigators, data managers, nursing services staff, pharmacists and medical personnel to ensure sufficient cooperation among participating investigators for each clinical research study; maintain liaison with participating University departments, industry sponsors and national agencies. Assist in the execution, administration and maintenance of protocols and clinical studies. Provide input into descriptions of research procedures. Develop study materials.
• Coordinate specific aspects of external review and align with internal processes. Manage and organize regulatory documentation from sites and regulatory authorities. Prepare regulatory submissions and perform on-site audits of research data.
• Monitor compliance with regulatory guidelines and ensure proper maintenance of documents. Maintain regulatory files and binders.
• Resolve monitoring and auditing issues that relate to regulatory activities.  
• Coordinate and prepare for monitor visits and audits.
• Enter data for the evaluation of clinical research metrics through our OnCore database as it relates to the initial regulatory review and submission process.
• Assure staff compliance with policies and procedures as they relate to regulatory activities.
• Prepare and deliver basic content that enhances knowledge of and compliance with internal and external standards and regulations.
• Attend all appropriate meetings as assigned: this will include but is not limited to with internal and external groups to provide reporting of study updates, educational and training meetings, meetings with team leads and supervisors, and meetings with sponsors or CROs
• Assist with data entry for current studies

About the Department of Pediatrics:

The Stead Family Department of Pediatrics is a national leader in pediatric medicine.  The Department's mission is to provide outstanding care to the children of Iowa and beyond by being a leader in state-of-the-art clinical care to children, performing cutting-edge research to find new treatments and cures for

childhood illnesses and educating the next generation of pediatric health care providers.  The Department comprises the medical and research staff of UI Stead Family Children’s Hospital.  UI Stead Family Children’s Hospital is one of the nation’s top-ranked pediatric care and research institutions, and Iowa’s only comprehensive children’s hospital.

About the Division of Endocrine and Diabetes:

The nationally recognized Division of Endocrinology & Diabetes has a tripartite mission by (i) providing expert care to children and adolescents with endocrine disorders, (ii) delivering award-winning endocrinology-related medical education, and (iii) conducting clinical and basic research to help address knowledge gaps in the field. The endocrine team is known for providing compassionate endocrine care coupled to expert diagnostic workup, treatment, and patient education. The team is headed by one dozen faculty physicians and subspecialty trained pediatric nurse practitioners. These providers collaborate with certified diabetes educators, endocrine nurses, dietitians, psychologists, and social workers to provide personalized care. The faculty consistently earns outstanding patient satisfaction scores. The endocrine faculty expertise is recognized regionally, nationally, and even internationally. All our faculty are board certified/eligible in the subspecialty of pediatric endocrinology.