Compliance Coordinator - ICTS Regulatory Core
The Regulatory Compliance Coordinator I in the Institute for Clinical and Translational Science will be an integral member of the regulatory team in the ICTS. This position will provide support for the regulatory team within the ICTS 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 I will coordinate and manage clinical trials and research study regulatory activities within the ICTS.
Duties to include but not limited to:
Investigation, Remediation and Reporting of Complaints and Reviews
- Assist with monitoring compliance with basic regulatory guidelines, including local, federal, and sponsor-specific guidelines; ensure proper maintenance of documents.
- Resolve basic monitor and auditing issues that relate to regulatory activities.
- Assist and coordinate with sponsor for on-site audits and monitor visits of research and clinical data.
- Perform basic evaluation of deviations.
- Monitor and maintain compliance of regulatory guidelines and documents. Maintain regulatory files and binders. May assist in converting files and binders into an electronic file as directed by senior compliance coordinator.
Consultation, Risk Assessment and Interpretation/Research of Regulations
- Identify basic data problems and implement change with direction.
- Assess basic problems related to protocol.
- Develop basic study and recruitment materials, as directed, used in conduction of study in order to maintain compliance. Provide development of resources that will aid in study recruitment and assist in getting these resources IRB approved.
Management of Clinical Trials and Internal/External Review Processes & Policies
Opening, maintaining, and closing clinical trials under the direction of the senior reg team members. After entry-level training/on-boarding is completed, the PNB1 Coord. I should be capable of maintaining 2-3 new studies, including start-up, simultaneously: also capable of modifying 4-5 existing studies and/or continued reviews.
Prepare and submit appropriate Human Subjects Review forms and application materials to the Institutional Review Boards as directed by a senior compliance coordinator.
Prepare and submit application forms 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 and under direction.
Assists in the regulatory process and document preparation used in the implementation and maintenance of basic clinical trials and research studies.
Under the direction of a senior compliance coordinator, you may prepare and submit 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; may prepare and/or manage all regulatory requests to sponsors and detailed letters of correspondence to the IRB of record.
May collaborate with 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 under the guidance of a senior compliance coordinator.
Assist senior compliance coordinators on data analysis for the evaluation of clinical research metrics through our ICTMS database as it relates to the initial regulatory review and submission process.
Attend and contribute to all appropriate meetings as assigned; may assist in creating meeting materials: 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.
Training & Educational Programs
Prepare and deliver basic content, materials and resources that enhance knowledge of and adherence to internal and external standards and regulations.
About ICTS: The Institute for Clinical and Translational Science (ICTS) at the University of Iowa was approved by the Iowa Board of Regents in 2007 to support the work of investigators involved in clinical and translational science. Our mission is to accelerate translational science through programs to develop the translational workforce, to promote engagement of community members and other stakeholders, to promote research integration across the lifespan, and to catalyze innovative clinical and translational research. These efforts will lead to the development of novel therapies and healthcare delivery strategies, the integration of translational research and clinical practice, and, ultimately to measurable improvements in the health of Iowa and the nation.
Percent of Time: 100%
Pay Grade: 3B
https://hr.uiowa.edu/pay/guide-pay-plans
Benefits Highlights:
-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
Experience, 1 year, preparing submissions for institutional review board and other ethical applications.
Experience, 1 year, in processing research regulatory documents.
Excellent written, verbal, and interpersonal communication skills.
Strong organizational, time management, and attention-to-detail skills, with the ability to independently coordinate multiple projects and priorities.
Proficiency in computer software applications, including spreadsheets and databases.
Knowledge of regulatory affairs and Good Clinical Practice (GCP) in clinical research, with the ability to work independently.
Demonstrated ability to handle sensitive and confidential information appropriately.
Desirable Qualifications
Experience with OnCore, eREG, REDCap, Epic and I-CART.
CCRP Certification
Previous experience working with University of Iowa systems, policies, procedures, and administrative processes.
Application Process:
In order to be considered for an interview, applicants must upload the following documents and mark them as a “Relevant File” to the submission:
Resume
Cover Letter
Successful candidates will be required to self -disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process.
For additional questions, please contact Amy Stewart at amy-stewart@uiowa.edu
This position is not eligible for University sponsorship for employment authorization.
Equal opportunity employer
The University of Iowa is an equal opportunity 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, or associational preferences.
Persons with disabilities who need assistance or accommodations with the application or interview process may contact University Human Resources/Faculty and Staff Disability Services, (319) 335-2660 or fsds@uiowa.edu. For jobs in UI Health care, please contact UI Health care Leave & Disability Administration at 319-356-7543.
