Regulatory Coordinator - Cancer Center

The Holden Comprehensive Cancer Center at the University of Iowa is seeking to hire a Regulatory Coordinator to coordinate and manage clinical trial regulatory activities within the Clinical Research Services, Holden Comprehensive Cancer Center (HCCC).
Duties To Include
100% Management of Clinical Trials and Internal/External Review Processes & Policies

• Resolve monitoring and auditing issues that relate to regulatory activities.
• Monitor compliance with regulatory guidelines and ensure proper maintenance of documents. Maintain regulatory files and binders.
• Responsible for opening, maintaining, and closing clinical trials: provide leadership, oversight and management of multiple complex clinical studies
• 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
• Enter data for the evaluation of clinical research metrics through our OnCore database as it relates to the initial regulatory review and submission process.
• Responsible for regulatory process and document preparation used in the implementation and maintenance of clinical trials sponsored by industry, national agencies, consortia, and cooperative
• 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.
• 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.
• Prepare and deliver basic content that enhances knowledge of and compliance with internal and external standards and regulations.
• Coordinate and prepare for monitor visits and audits.
• 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.
• Assure staff compliance with policies and procedures as they relate to regulatory activities.
• 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.
• 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.
• 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.

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.
UI Health Care Core Values (WECARE)
Welcoming
We strive for an environment where everyone has a voice that is heard, that promotes the dignity of our patients, trainees, and employees, and allows all to thrive in their health, work, research, and education.
Excellence
We aim to achieve and deliver our personal and collective best in the pursuit of quality and accessible healthcare, education, and research.
Collaboration
We encourage collaboration with healthcare systems, providers, and communities across Iowa and the region, as well as within our UI community. We believe teamwork - guided by compassion - is the best way to work.
Accountability
We behave ethically, act with fairness and integrity, take responsibility for our own actions, and respond when errors in behavior or judgement occur.
Respect
We are committed to ensuring the UI Health Care is an inclusive environment where individuals from the full spectrum of diversity - which includes identity, backgrounds, cultures, ability, and perspective - feel safe, seen and valued.
Equity
We dedicate ourselves to equity and fairness in research, health care, education, and health.
Percent of Time: 100
Pay Grade: 3B
https://hr.uiowa.edu/pay/guide-pay-plans
Benefits Highlights

• Regular salaried position located in Iowa City, Iowa
• For more information about Why Iowa?, click here
• Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans

Required Qualifications

• Knowledge of regulations that apply to human research
• A Bachelor's Degree or an equivalent combination of education and experience
• Excellent written, verbal and interpersonal communication skills
• Excellent organizational skills
• Proficient in computer software applications including spreadsheet and database experience
• Proven ability to utilize medical terminology
• Prior experience with Institutional Review Board application materials and processing
• Experience in coordinating multiple projects and diverse functions independently
• 1-3 years administrative and/or program experience

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.
References: Five professional references will be requested and required at a later step in the recruitment process
With additional questions, please reach out to Sarah Waldschmidt at [email protected]
Additional Information

• Classification Title: Compliance Coordinator
• Schedule: Full-time
• Appointment Type: Professional and Scientific

Compensation

• Pay Level: 3B

Contact Information

• Contact Email: [email protected]
• Organization: Healthcare
• Contact Name: Sarah Waldschmidt

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, religion, national origin, age, sex, pregnancy (including childbirth and related conditions), disability, genetic information, status as a U.S. veteran, service in the U.S. military, sexual orientation, gender identity, or associational preferences.