Compliance Coordinator - Pediatrics Hematology/Oncology

The UI Stead Family Department of Pediatrics, Division of Hematology/Oncology is seeking a Compliance Coordinator at 50% effort. This position is to coordinate and manage clinical trial regulatory activities within the Clinical Research Services, in the Stead Family Department of Pediatrics. This is a specified term position.

Hybrid within Iowa: Following an onsite training period, this position is eligible for a combination of on-campus and remote work. Remote work must be performed within Iowa and will require a work arrangement form to be completed upon the start of your employment. Per policy, work arrangements will be reviewed annually and must comply with the remote work program and related policies and employee travel policy when working at a remote location.

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, Western Institutional Review Board (WIRB) and the NCI Central IRB; prepare consent forms for research protocols in Pediatrics
• 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
• Hold the following minimum capacity: 25 industry single mog maintenance, 15 industry multi-mog maintenance, 15 IITs study maintenance, 50 NCTN, or 4 studies per month activation.

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 Hematology/Oncology:

The Division of Pediatric Hematology/Oncology at University of Iowa Children’s Hospital is a pioneer in the care and treatment of childhood cancers and blood disorders. It is part of the Holden Comprehensive Cancer Center, and a member of the Children’s Oncology Group (COG), a national consortium of pediatric cancer centers. The COG is well known for its new and innovative ways of treating childhood cancer. The division has a long history of success in bringing hope to patients with programs such as our blood and bone marrow transplant, comprehensive sickle cell program, and comprehensive hemophilia center.

The mission of the division is to treat and cure children and adolescents with cancer and blood diseases who live in Iowa by delivering personalized multidisciplinary, state-of-the-art care, through participation both in nationally and locally designed protocols.