The Holden Comprehensive Cancer Center at the University of Iowa is seeking a Compliance Regulatory Coordinator that will be an integral member of the research team in the HCCC. This position will provide support for the regulatory team within the HCCC by performing activities which are vitally important to establish the research core for the department, as well as to grow and foster innovation through research support endeavors. The Compliance Regulatory Coordinator will coordinate and manage clinical trials and research study regulatory activities within the HCCC.
This position is eligible for a hybrid work arrangement of both on-campus (UIHC) and remote work within the state of Iowa upon completion of a training period, with the majority of work taking place on the U of I/UIHC campus. 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:
Investigation, Remediation and Reporting of Complaints and Reviews
Monitor compliance with regulatory guidelines and ensure proper maintenance of documents.
Resolve monitor and auditing issues that relate to regulatory activities
Aid and coordinate with sponsor for on-site audits and monitor visits of research and clinical data.
Monitor and maintain compliance of regulatory guidelines and documents. Maintain regulatory files and binders.
Assist in the evaluation of deviations and determine if reportable
Consultation, Risk Assessment and Interpretation/Research of Regulations
Assist with identification of data problems and implement change as needed. Make recommendations for query resolution.
Assist the Principal Investigator and study team in the development, execution, administration and maintenance of protocols and clinical studies and provide input into descriptions of complex research procedures.
Assess problems related to protocol. Assist with CRF development, database development and maintenance, in order to maintain compliance.
Assist in the development of complex study and recruitment materials used in conduction of study in order to maintain compliance.
Monitor developments in regulations and communicate to affected units
Management of Clinical Trials and Internal/External Review Processes & Policies
Responsible for opening, maintaining, or closing of clinical trials
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 Boards
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
Responsible for regulatory process and document preparation used in the implementation and maintenance of clinical trials and research studies
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 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 a 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 with assistance
Assist with data analysis for the evaluation of clinical research metrics through our OnCore database as it relates to the initial regulatory review and submission process.
Attend and contribute 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
Policy Development
Provide information/feedback about policies to supervisor.
Training & Educational Program
Prepare and deliver basic content that enhances knowledge of and adherence to internal and external standards and regulations.
UI Health Care Core Values (WE CARE)
Welcoming
We are welcoming to the community, partners, staff, and patients utilizing the collective strength of our people.
Excellence
We achieve and deliver our personal and collective best in the pursuit of quality and accessible health care, education, and research.
Collaboration
We collaborate with health care systems, providers, and communities across Iowa and the region as well within our UI community. We believe teamwork- guided by compassion- is the best way to work.
Accountability
We behave ethically, act openly and with integrity in all that we do, taking responsibility for our actions.
Respect
We create an inclusive environment where every individual feels safe, valued, and respected, supporting the well-being and success of all members of our community.
Empowerment
We commit to fair access to research, health care, and education for our community and opportunities for personal and professional growth for our staff and learners.
SUPERVISION RECEIVED:
Senior Regulatory Compliance Coordinator and Regulatory Coordinator Manager
SUPERVISION EXERCISED:
NA
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%
Work Schedule: Monday - Friday, Hours generally worked between 7:30am-5pm
Pay Grade: 3B
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
For more information about Why Iowa?, click here
REQUIRED QUALIFICATIONS:
A Bachelor's degree in a Health Science field or an equivalent combination of education and research experience is required.
Excellent written, verbal, and interpersonal communication skills
Experience in computer software applications including spreadsheet and database experience.
Understanding of and ability to handle confidential information.
Experience in coordinating multiple projects and a variety of functions independently.
Excellent organizational skills. Ability to work independently.
Excellent time management skills and ability to perform detail-oriented work is desired.
•
DESIRABLE QUALIFICATIONS:
Experience with Oncore, eREG, REDCap, Epic and I-CART.
Experience preparing submissions for institutional review board and other ethical applications.
Experience in processing research regulatory documents.
Experience in regulatory affairs
Working knowledge of Good Clinical Practice (GCP) in research
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 required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification.
References: Five professional references will be requested and required at a later step in the recruitment process
This position is not eligible for University sponsorship for employment authorization.
With additional questions, please reach out to Sarah Waldschmidt at sarah-waldschmidt@uiowa.edu
