Clinical Trials Research Associate - Ophthalmology

University of Iowa Health Care, Department of Ophthalmology & Visual Sciences, is seeking a full time Clinical Trials Research Associate (PRV2; 4A). The Clinical Trials Research Associate coordinates the performance of clinical research by managing subject recruitment, scheduling, and enrollment of study subjects, administering study protocols, overseeing data processing and management, maintaining compliance with regulatory guidelines and documents, gathering information and assisting in the preparation of material for inclusion in reports and publication for the University of Iowa Health Care, Department of Ophthalmology & Visual Sciences, and performing leadership and financial responsibilities as indicated. Position responsibilities include:

Protocol Development/Management & Study Responsibilities

• Demonstrate knowledge of research techniques and procedures relating to the performance of medical/social science research.
• Assist and advise in study design and protocol development; provide input into descriptions of complex research procedures.
• Perform and oversee execution, administration and maintenance of study protocols and clinical trial studies.
• Oversee case report form(s) development, completion, and implementation.
• Perform and monitor randomizations.
• Develop complex study materials.  
• Design, implement and maintain an interdepartmental research registry
• Serve as liaison between collaborating treatment providers and/or departments
• Applies data governance policies for UI and HCIS integration with clinical trials.
• Works with health information in multiple, diverse environments, including but not limited to external entities requiring electronic data capture for clinical trials.
• Utilizes current practice based on code of federal regulations, state, local and institutional polices in HIPAA practices.
• Provides detailed insights into most health information concepts and the application to clinical trials, use of secure electronic databases, and management of master trial file systems.
• Articulates key benefits, drawbacks, rationale for health information standards, policies, practices applicable to human clinical research.
• Contributes to discussions of critical operational issues and considerations regarding health information used for clinical research versus standard of care. Explains health information organizations, industry best practices and rationale.

Research/Clinical Activities/Subject Recruitment & Enrollment

• Recruit potential study participants via known registries and applicable clinics.
• Screen potential study participants based upon project criteria.
• Track and follow up with prospective study participants within project guidelines.
• Manage the scheduling of testing and appointments, including arrangement of travel, on-site room and equipment reservations, coordination of the test day agenda, and confirmation of arrangements with scheduled study participants.
• Educate study participants on scope of study, potential risks and benefits, possible alternatives, and study requirements for participants.
• Obtain informed consent and other required regulatory documents, and monitor participant experience for reportable events.
• Maintain contact information of project participants in a secure database and proactively manage scheduling of follow up study visits to comply with project longitudinal goals. 

Data Collection Monitoring

• Independently design, develop, test and maintain clinical research trials data systems.
• Score and record data collected
• Perform and oversee data entry, data audit, and maintenance of computerized databases.
• Revise and implement change in data collection as indicated.
• Validate data, review query reports and make recommendations for resolutions.
• Perform and monitor randomizations.
• Perform on-site monitor visits and audits of research and clinical data.
• Provide appropriate institutional access for monitor visits.
• Resolve all monitoring visit issues, review query reports, and address action items.
• Perform chart review for data collection within protocol guidelines.
• Acquire knowledge of and ability to utilize tools, techniques, and processes for gathering and reporting data in a particular department. Participate in the adverse event reporting (AE) process from initial data receipt to final submission.
• Monitor external AE reporting systems for new adverse events and medication errors.
• Produce reports for AEs with supervision of principal investigator.
• Utilize organizational guidelines and procedures in AE reporting
• Perform library research on specified topics and prepare bibliographies and abstracts according to instructions as needed.
• Assist in the preparation of material for reports to be written by faculty and staff on research projects.
• Respond to inquiries about assigned projects and present at informational sessions and panel discussions as requested.
• Prepare information upon request for reporting to funding source(s).
• May perform blood draws and/or visual acuity tests on study subjects with appropriate initial and onboarding training and in compliance with applicable study protocol(s).

Regulatory Guidelines and Documents:

• Manage and monitor compliance of regulatory guidelines and proper maintenance of documents; prepare regulatory submissions.
• Communicate with IRB staff and investigators, resolve all monitoring visit issues, and recommend corrective action for reportable events.
• Demonstrate experience with various IRB platforms internal and external
• Scrutinizes, reviews and produces written materials relevant to the clinical trials. Edits out technical jargon as needed. Applies organizational guidelines for writing reports, correspondence, documentation, and submissions
• Participates in the development of system or process documentation and reports. Interacts with team members by listening to constructive comments and uses feedback when editing documents and communication responses.

Human Resources/Leadership:

• Provide functional oversight of assigned research students, research team members and support staff.
• Assist in the mentorship and education of new staff in their onboarding and continuing education/growth under the supervision of principal investigator and functional supervisor
• Represent the University of Iowa Department of Ophthalmology & Visual Sciences and University of Iowa Health Care Principal Investigators at coordinator and trial sponsored annual meetings. Leads in discussions by providing thoughtful recommendations and input on functionality of the trials.

Financial Responsibility

• Demonstrate knowledge of, and ability to, apply, policies and practices for using a planned budget, administering, and encumbering corporate funds for clinical trials.
• Demonstrate the ability to maintain clinical trial spreadsheets,  record maintenance to close out trial activities, and manage regulatory issue to reflect the sponsor's protocol, follows contractual budget and applies organizational tools for protocol accountability and invoicing.
• Choose organizational practices which allow for proper invoicing and reimbursements from the sponsor.
• May administer and/or monitor budget for study(ies).

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

Tentative Start Date: Spring/Summer 2025

Location: UIHC, Iowa City

Rotations: N/A

On Campus: This position is performed fully on campus.

Pay Level: 4A