The University of Iowa Health Care, Department of Radiology is seeking to hire one applicant for a Clinical Trials Research Assistant/Data Manager (25006305) or Research Associate (25006308). Please apply to the specific position you wish to be considered for, or both.

The Clinical Trials Research Associate is responsible for the screening, recruitment, consenting, enrolling, assessment and monitoring of subjects for studies using novel magnetic resonance imaging to evaluate lung function in chronic lung diseases, including lung transplant rejection, asthma, chronic obstructive pulmonary disease, and lung cancer. In addition, this position will be responsible for assuring study compliance and reviewing data quality and management, communicating concerns to the principal investigator. Other job requirements will include organization of data for analysis, support for paper and grant submissions, and coordination of research activities with a group of investigators.

Duties include:

• Screen, recruit, enroll, and obtain informed consent for clinical trials.

• Oversee the recruitment of subjects and scheduling of trial-related procedures.

• Educate study participants on the scope of the study, potential risks and benefits, possible alternatives, and study requirements for participants.

• Relay information to the principal investigator and verify study participant eligibility.

• Assist with subject recruitment by mining databases and EPIC.

• Assist with clinical and data coordination for research activities and set up supplies for study visits.

• Participates in clinical research visits, which includes Epic documentation, checking vitals, portable pulmonary function testing, drawing blood and placement of IV’s.

• Validate data, query resolution, and make recommendations for resolution.

• Revise and implement change in data collection.

• Coordinate the processing of data from various sites/centers/studies

• Process specimens per protocol, as well as store specimens, maintain lab areas, inventories, orders.

• Assist in retrieval of basic study data as it pertains to specimens.

• Monitors visit reports for studies.

• Manage and organize regulatory documentation from sites and regulatory authorities. Prepare regulatory submissions.

• Perform on-site audits of research and clinical data.

• Monitor compliance with regulatory guidelines and proper maintenance of documents.

• May recommend corrective action for reportable events.

• May communicate with IRB staff and investigators.

• Assist in the design, development, execution administration, and maintenance of protocols and clinical studies.

• Assist in study design and protocol development and provide input into descriptions of complex research procedures.

• Oversee CRF development.

• Review query reports.

• Resolve all monitoring visit issues.

• Perform and monitor randomizations.

• Develop complex study materials.

• Serve as a liaison to local health care practitioners, agencies, and sponsors.

• Manages and maintain protocols.

• Research, change, and submit protocol amendments for IRB approval.

• Prepares IRB documents for protocol approval, modifications and yearly renewals

• Monitors protocol status as it is process through the IRB.

• Responsible for conducting training of new protocols and changes to existing protocols.

• May provide functional and/or administrative supervision. Mentor new staff under direction.

• May provide training to other lab staff as required by the study protocol.

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: Mon - Fri 8:00 am – 4:30 pm

Location: Iowa City, IA

Pay Grade: 4A https://hr.uiowa.edu/pay/guide-pay-plans

Required Qualifications:

• Bachelor’s Degree in a STEM (Science, Technology, Engineering, or Math) or related educational field or an equivalent combination of education and experience is required.

• Considerable (2-4 years) experience with and participation on clinical trials is required.

• Excellent written, verbal communication, interpersonal and organizational skills are required.

• Ability to fluctuate occasionally working nights and weekends to enroll patients and/or monitor study patients as may be required by the enrollment protocol of the study.

• Experience working with patients in a hospital or clinical setting including providing care and reviewing medical information.

• Knowledge of Microsoft Office Word, Excel, PowerPoint, Outlook, Adobe Acrobat

• Previous research protocol management experience is required

• Knowledge of regulatory guidelines and procedures is required.

• Experience with protocol and medical research data management is required.

Desirable Qualifications:

• Ability to work independently and manage multiple priorities or studies at one time.

• ACRP or SoCRA Certification

• Experience with medical research data management

• Experience with laboratory functions including, blood draws, IV placement, processing specimens per protocol, as well as storage of specimens, maintaining lab areas, inventories, orders.

• Experience working with Epic, RedCap, Clinicaltrials.gov and IRB submission systems.

Benefits Highlights:

• Regular salaried position. Located in Iowa City, Iowa

• 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

Application Process:

To be considered, applicants must upload a resume and a 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. Applications will be accepted until position is filled.