Regulatory Coordinator, Ophthalmology Human Subjects Research
University of Iowa

University of Iowa Health Care, Department of Ophthalmology & Visual Sciences, is seeking a full time Regulatory Coordinator, Ophthalmology Human Subjects Research (OHSR) (PNB1; 3B). The Regulatory Coordinator, Ophthalmology Human Subjects Research (OHSR) demonstrates expertise in the regulatory requirements for the conduct of clinical trials and research involving human subjects for the Department of Ophthalmology & Visual Sciences at the University of Iowa Healthcare. The department engages in a variety of projects funded by the NIH and the VA, industry-sponsored clinical trials, and investigator-initiated projects. Research includes treatment, retrospective, and observational studies, developing and testing therapeutic devices, translational medicine, and AI-driven tools, all in the service of bettering outcomes for patients with eye disease. Many Ophthalmology projects also have a genetic component. The Regulatory Coordinator (OHSR) serves as the main point of contact for faculty and learners who are navigating the complexities of regulatory compliance for human subjects research. The principal responsibility of the Regulatory Coordinator will be to assist faculty, staff, and students prepare for IRB submission, maintain approved status, and work with other regulatory aspects of their human subjects work. The second major responsibility of the Regulatory Coordinator is educational, i.e. teaching faculty, staff, and students to understand the underlying principles of the protection of human subjects and training them when there are changes in the regulatory landscape.

Key responsibilities include:

Management of External Standards Review Processes

• Serve as the department's main resource for IRB and human subjects knowledge.
• Serve as the department's liaison with UI's Human Subjects Office and external IRB of record entities.
• Establish and implement a triage system for IRB approval requests in the department.
• Complete IRB submissions for new projects, renewals, and closures.
• Help department researchers develop realistic timelines for IRB approvals and understand the documentation required.

Training & Educational Programs

• Advise faculty, staff, and learners on matters related to regulatory compliance and human subjects protection.
• Disseminate information about changes in regulations and processes related to human subjects research.
• 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

Consultation, Risk Assessment and Interpretation/Research of Regulations

• Monitor compliance of regulatory guidelines and proper maintenance of documents
• Other duties as assigned, in support of the work of the clinical research team.
• Assure staff compliance with policies and procedures as they relate to regulatory activities.

Investigation, Remediation and Reporting of Complaints and Reviews

• Recommend corrective action for reportable events.
• Resolve monitoring and auditing issues that relate to regulatory activities.

The University of Iowa Health Care Department of Ophthalmology & Visual Sciences has a long history of providing outstanding care for our patients, conducting leading-edge collaborative research, and educating the next generation of ophthalmologists and vision science researchers. We have consistently been ranked nationally in the top ten of Ophthalmology Departments by U.S. News and World Report since 1994. We are actively engaged in clinical trials and research studies involving vision and eye diseases. Our physicians and researchers collaborate with colleagues on many investigator-led, industry-sponsored, or government-supported trials that seek to improve vision for our patients and beyond.

University of Iowa Health Care-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.®

Percent of Time: 100%

Schedule: Monday - Friday, 8:00a-5:00p

Location: UIHC, Iowa City

Rotations: N/A

On Campus: This position is performed fully on campus.

Pay Level: 3B

REQUIRED QUALIFICATIONS

• A Bachelor's degree or an equivalent combination of education and experience is required.
• 1-3 years administrative and/or program experience in clinical research.
• Excellent written, verbal and interpersonal communication skills.
• Excellent organizational skills.
• Prior experience with Institutional Review Board application materials and processing.
• Experience in coordinating multiple projects and a variety of functions independently.
• Knowledge of regulations, guidelines and procedures which apply to human research.
• Proficient in computer, software and database systems.

DESIRED QUALIFICATIONS

• 5+ years of experience in clinical trials research.
• Knowledge of ophthalmology and vision research
• Experience working in an academic clinical research environment.
• Demonstrated completion of GCP (Good Clinical Practice) training
• Proven ability to utilize medical terminology
• Experience following specific protocol techniques and management.
• Experience teaching or training others new skills or knowledge.
• Clinical Research Certification (ACRP and/or SOCRA)
• Experience with VA IR and/or VA-IRB-03
• Knowledge of University of Iowa policies, procedures and regulations.

POSITION & APPLICATION DETAILS

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

Job openings are posted for a minimum of 14 calendar days and may be removed from posting and filled any time after the original posting period has ended.

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. This position is not eligible for University sponsorship for employment authorization.

For additional questions, please contact Melissa Monhollon, HR Manager, at melissa-monhollon@uiowa.edu or 319-356-4674.

Additional Information

• Classification Title: Compliance Coordinator
• Appointment Type: Professional and Scientific
• Schedule: Full-time
• Work Modality Options: On Campus

Compensation

• Pay Level: 3B
• Starting Salary Minimum: 46045.00
• Starting Salary Maximum: Commensurate

Contact Information

• Organization: Healthcare
• Contact Name: Melissa Monhollon
• Contact Email: melissa-monhollon@uiowa.edu

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