The Holden Comprehensive Cancer Center at the University of Iowa is seeking a Senior Compliance Coordinator to coordinate and manage clinical trial regulatory activities within the Clinical Research Services, Holden Comprehensive Cancer Center (HCCC).

Duties to include:

95% Management of Clinical Trials and Internal/External Review Processes & Policies

• Responsible for opening, maintaining, and closing clinical trials: provide leadership, oversight and management of multiple complex clinical studies
• Provide cross coverage support within regulatory team as needed
• Manage 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), Western Institutional Review Board (WCG), Advarra IRB, the NCI Central IRB and other IRBs as appropriate
• 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 regulatory process and document preparation used in the implementation and maintenance of clinical trials sponsored by industry, national agencies, consortia, and cooperative
• Responsible for the preparation and submission of documents related to research protocol annual reviews, modifications, FDA Investigational New Drug (IND) applications, Adverse Events, Safety Reports and other reportable events to IRB as needed and within internal deadlines of completion; consent creation and negotiations with sponsors; manage all regulatory requests to sponsors and detailed letters of correspondence to the IRB of record
• Serve as an expert 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, industrial sponsors and national agencies
• Monitor compliance with regulatory guidelines and ensure proper maintenance of documents. Maintain regulatory files and binders. Coordinate and prepare for monitor visits and audits. Resolve monitor and auditing issues that relate to regulatory activities
• Enter data for the evaluation of clinical research metrics through our OnCore database as it relates to the initial regulatory review and submission process
• Attend, contribute, and lead in all appropriate meetings as assigned; assist in creating meeting agenda outlines: 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: 40 industry single mog maintenance, 30 industry multi-mog maintenance, 30 IITs study maintenance, 70 NCTN, or 8 studies per month activation

2% Policy Development

• Assist regulatory specialist in identifying new policies as needed based upon regulatory changes and/or internal needs

3% Training & Education

• Assists in recommending educational priorities
• Assists regulatory specialist in training efforts in onboarding new staff members

SUPERVISION RECEIVED:

Supervision is received by Regulatory Compliance Manager

SUPERVISION EXERCISED:

None

University of Iowa Hospitals & Clinics—recognized as one of the best hospitals in the United States—is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, quality health care and excellent service for our patients. Simply stated, our mission is: Changing Medicine. Changing Lives.®

Holden Comprehensive Cancer Center is Iowa’s only NCI-designated comprehensive cancer center. The NCI designation recognized our cancer center, and its research scientist, physicians, and other health care professionals, for their roles in advancing cancer research that impacts on our ability to prevent, detect and treat our patients with cancer. Not just a floor, or a building, or even confined to a single college. Holden Comprehensive Cancer Center coordinates all cancer-related research, education, and patient care by faculty from 41 departments and six colleges, as well as UI Hospitals and Clinics and UI Children’s Hospital.

Percent of Time: 100%

Pay Grade: 4B

https://hr.uiowa.edu/pay/guide-pay-plans

Benefits Highlights:

• Regular salaried position located in Iowa City, Iowa
• Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans

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