Pediatrics Regulatory Coordinator - Cancer Center
The Holden Comprehensive Cancer Center at the University of Iowa is seeking to hire a Regulatory Coordinator. This position will coordinate and manage clinical trial regulatory activities within the Clinical Research Services office of the Holden Comprehensive Cancer Center (HCCC).
- 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 the HCCC.
- 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 insure 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 to 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.
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: 3B https://hr.uiowa.edu/pay/pay-plans/professional-and-scientific-pay-structure-b
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
- For more information about Why Iowa?, click here
Required Qualifications
- A Bachelor’s Degree or an equivalent combination of education and experience
- 1-3 years administrative and/or program experience
- Excellent written, verbal and interpersonal communication skills
- Excellent organizational skills
- Proficient in computer software applications including spreadsheet and database experience
- Experience in coordinating multiple projects and diverse functions independently
- Prior experience with Institutional Review Board application materials and processing
- Knowledge of regulations that apply to human research
- Proven ability to utilize Medical terminology
Desirable Qualifications
- Experience working in a research facility with clinical oncology protocols or management of clinical data, i.e., laboratory values, toxicity levels
- Knowledge of University of Iowa policies, procedures and regulations
Application Process: In order to be considered, applicants must upload a resume and cover letter (under submission relevant materials) that clearly address how they meet the listed required and desired qualifications of this position.
Job openings are posted for a minimum of 14 calendar days.
Successful candidates will be subject to a criminal background check.
With additional questions, please reach out to Hannah Ihns at hannah-ihns@uiowa.edu
Equal Opportunity/Affirmative Action employer
The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, national origin, age, sex, pregnancy, sexual orientation, gender identity, genetic information, religion, associational preference, status as a qualified individual with a disability, or status as a protected veteran. The University also affirms its commitment to providing equal opportunities and equal access to University facilities. Women and Minorities are encouraged to apply for all employment vacancies. For additional information on nondiscrimination policies, contact the Coordinator of Title IX and Section 504, and the ADA in The Office of Equal Opportunity and Diversity, 319/335-0705 (voice) or 319/335-0697 (text), The University of Iowa, 202 Jessup Hall, Iowa City, Iowa, 52242-1316.
Persons with disabilities may contact University Human Resources/Faculty and Staff Disability Services, (319) 335-2660 or fsds@uiowa.edu, to inquire or discuss accommodation needs
