Role Description University of Iowa Health Care’s department of Patient Financial Services is seeking a Compliance Associate Director (AD) within Research. This role develops, implements, and directs programs to ensure institutional compliance with federal and state Research Billing regulations, and to ensure institutional compliance with the University of Iowa (UI) Health Care Conflict of Interest Policy. This position is eligible to participate in remote work and applicants who wish to work remotely will be considered. Training will be held either ONSITE or via Hybrid (Inhouse/Zoom) from the HSSB building at a length determined by the supervisor. Remote eligibility will be evaluated upon a satisfactory job training opportunity. 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. Position Responsibilities - Define, develop and recommend goals and objectives of the UI Health Care Research Billing Compliance Program. - Develop criteria for audits related to research billing programs. - Investigate potential violations of research billing compliance laws and regulations at UI Health Care. - Monitor changing Medicare clinical trials billing regulations and other federal legislations related to research protocols. - Serve as institutional resource for faculty, staff, departmental executive officers, UI Health Care executive leadership, principal investigators and research staff related to billing within research studies. - Monitor and identify daily operations at UI Health Care that may create research billing compliance and/or financial risk or vulnerabilities; develop policies and operational guidelines to avoid risk and noncompliance with regulations and policies. - Develop and oversee daily operations and workflows in the Epic system regarding billing for patients enrolled in clinical trials; continually monitor high dollar Epic work queues for compliance with criteria set by UI Health Care senior leadership. - Serve as official liaison to outside agencies, organizations and individuals for the Research Billing Compliance Program policies and procedures. Prepare reports and presentations on both programs to executive leadership and outside constituents as directed. - Develop, plan and oversee policies and procedures to effectively implement objectives of the UI Health Care Research Billing Compliance Program in order to ensure compliance with federal, state and other third-party clinical trial billing regulations. - In consultation with senior leadership and other units/orgs, create new policies and develop new workflows to remain current with regulatory and internal changes and systems. - Perform regular evaluation of Research Billing Compliance Program services based upon defined objectives. - Direct quality assessment review of the program as needed. - Review patient billing accounts and insurance claims for proper ICD-10 and HCPCS coding related to clinical trials billing; advise UI Health Care coders on coding and claims requirements for clinical trials billing. - Develop and present educational programs and written materials on research billing compliance; oversee development of educational materials by other staff. - Coordinate the communication of research billing compliance policies and procedures to faculty, staff, and UI Health Care researchers to ensure compliance with federal and state billing regulations. - Responsible for oversight of Research Billing Compliance staff, including interviewing, selection, training, monitoring job performance, annual evaluation, salary determination, promotion and disciplinary action. - Continually evaluate staffing requirements to optimize program operations. Schedule and delegate work to Research Billing Program staff. Assign priority projects as required to meet deadlines. - Assist in preparation of departmental budgets. - Monitor Research Billing Compliance Program allocations and expenditures. - Create, maintain and monitor UI Health Care websites for the Research Billing Compliance Program. - Serve on internal and external committees and task forces as assigned. Qualifications - Master’s degree or an equivalent combination of education and experience required. Requirements - Five to seven years’ experience program management. - Supervisory experience (typically 1-3 years) in a high-volume, fast-paced customer service teamwork environment successfully resolving a variety of personnel issues. - Proficiency with office software such as Microsoft Office Suite (Word, Excel, PowerPoint). - Working experience with multiple technology platforms such as Cirius and/or Epic. - Proven success with identifying trends, opportunities for operational improvement, etc and providing solutions to improve processes and workflows. - Maintain current knowledge and stay aware of industry trends and continually strive for improvement with both technical and professional skills. - Working knowledge of HIPAA laws, CMS regulations, and treats all information received confidentially. - Strong planning and organizational skills. Desirable Qualifications - Working knowledge of Epic HB and/or PB Resolute modules. - Experience in a union environment. - Working experience in an academic medical setting. Application Process In order to be considered for an interview, applicants must upload the following documents and mark them as a “Relevant File” for the submission: - Resume - (optional) Cover Letter Job openings are posted for a minimum of 7 calendar days and may be removed from posting and filled any time after the original posting period has ended. Applications will be accepted until 11:59 PM on the date of closing. 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 Veronica Clark at veronica-clark@uiowa.edu .

• Supports and demonstrates IMA’s core values • Values and understands the importance of diversity, equity, and inclusion among all IMA associates. • Execute basic certificate reviews with low complexity, ensuring accuracy and completeness. • Gains proficiency in key systems, including Outlook, Teams, SharePoint, TrustLayer, and myCOI. • Develop effective time management skills to meet deadlines and efficiently prioritize tasks. • Consistently complete all assigned tasks with a focus on meeting departmental turnaround times and quality standards. • Performs the essential functions of the role within an IMA office environment 0-50% of the time.

Role Description We are seeking a highly organized, detail-oriented, and collaborative Clinical Trial Assistant (CTA) to support the execution of clinical studies across our gene therapy development programs. Reporting to the Clinical Operations team, the CTA will provide operational, administrative, and systems support for clinical trials conducted in accordance with ICH-GCP guidelines, company SOPs, and applicable regulatory requirements. This role will partner closely with Clinical Trial/Program Managers, Clinical Operations, Data Management, Regulatory Affairs, Quality, vendors, CROs, and clinical sites to support study execution activities, documentation management, vendor coordination, and inspection-ready clinical operations processes. The ideal candidate is proactive, adaptable, and excited to contribute within a fast-paced biotechnology environment focused on advancing transformative genetic medicines for patients. Key Responsibilities - Provide operational and administrative support for global clinical studies across multiple gene therapy programs and study phases. - Support Trial Master File (TMF) management activities, including document collection, quality review, filing, reconciliation, and maintenance of inspection readiness. - Assist with clinical study start-up, maintenance, and closeout activities, including site documentation tracking, essential document management, investigator file support, and study communications. - Coordinate clinical meetings, including agenda development, meeting logistics, action item tracking, and preparation of meeting minutes. - Support vendor and CRO oversight activities, including tracking deliverables, invoices, contracts, purchase orders, and operational documentation. - Maintain clinical trial trackers, dashboards, study plans, timelines, enrollment reports, issue logs, and operational metrics. - Assist with investigator meeting planning, site training logistics, vendor meetings, and internal cross-functional study meetings. - Support regulatory and ethics submission preparation by coordinating required documentation and ensuring timely completion of deliverables. - Collaborate cross-functionally with Clinical Operations, Regulatory, Data Management, Safety, Quality, Medical Writing, and external partners to support efficient study execution. - Maintain clinical systems and databases, including CTMS, eTMF, document repositories, training records, and study-related operational tools. - Track study-related activities, deadlines, training assignments, and compliance requirements to support high-quality clinical trial execution. - Contribute to SOP development, process improvements, template management, and continuous operational excellence initiatives within the Clinical organization. - Ensure activities are conducted in compliance with GCP, applicable regulations, company policies, and quality standards. Qualifications - Bachelor’s degree in life sciences, healthcare, biology, nursing, public health, or related discipline preferred. - 1–4 years of experience supporting clinical research, clinical operations, pharmaceutical, biotechnology, CRO, academic research, or healthcare environments. - Experience supporting clinical trials or clinical operations activities strongly preferred. - Knowledge of clinical research regulations, ICH-GCP guidelines, clinical trial processes, and essential clinical documentation preferred. - Experience working with clinical systems such as CTMS, eTMF, Veeva Vault, Trial Interactive, Medidata, or related platforms preferred. - Strong organizational, project coordination, and multitasking skills with exceptional attention to detail. - Excellent written, verbal, and interpersonal communication skills. - Strong proficiency with Microsoft Office Suite (Excel, Word, Outlook, PowerPoint) and collaborative business tools. - Ability to manage multiple priorities and adapt effectively within a dynamic, fast-paced biotech environment. Additional Valued Qualifications - Experience in gene therapy, rare disease, neurology, oncology, cell therapy, biologics, or advanced therapeutics environments preferred. - Prior experience supporting outsourced clinical trial models and working with CROs, vendors, and clinical sites. - Exposure to global clinical studies and regulatory inspection readiness activities preferred. - Experience in emerging biotechnology or growth-stage life sciences companies preferred. Benefits - Comprehensive benefits package, including competitive employer premium contributions. - Meaningful stock option grants. - PTO, sick time and holiday pay. - Generous Parental Leave program. - Pre-tax medical and dependent care programs. - STD, LTD, Life and AD&D. - Professional development opportunities. - Team-building events. - Fully stocked micro-kitchen. - Fitness center at South San Francisco location.

• Conduct research on market trends, regulatory updates, and competitor payment product features relevant to BPay • Assist in preparing internal reports, dashboards, and data summaries for weekly reviews and stakeholder updates • Support documentation of operational processes, SOPs, and compliance checklists • Help track and follow up on open action items, task updates, and process improvement tickets • Coordinate minor cross-team requests and fill in operational process updates as directed • Assist with data gathering and formatting for compliance and ops audits