Clinical Trials Research Associate - Radiology

UIOWA•Iowa City, IA

3d•Onsite

About The Position

The University of Iowa Health Care, Department of Radiology is seeking a Clinical Trials Research Associate! The Clinical Trials Research Associate is responsible for performing clinical/health care research activities in support of clinical trials in the Department of Radiology. Assist in the design, development, execution, administration and maintenance of protocols and clinical studies. Screen recruit, enroll and obtain informed consent of clinical research activities. Participate in the design, development, and testing of clinical research trial data systems. Mange and organized regulatory documentation. Position Responsibilities: Key Areas of Responsibility Research/Clinical Activities; Subject Recruitment and Enrollment Screen, recruit, consent, enroll, assess and monitor subjects for both general research and clinical trial projects. Oversee the recruitment of subjects and scheduling off trial-related procedures Educate study participants on the scope of the study, potential risks and benefits, possible alternatives, and requirements for participants Relay information to the principal investigator and verify study participant eligibility Identify potential participants through clinics, imaging reports, and procedure schedules Conduct eligibility screening and maintain screening and enrollment logs Coordinate and document informed and retention strategies Maintain confidentiality and comply with HIPAA requirements Participates in clinical research visits, which includes Epic documentation, checking vitals, precision of research questionnaires, patient education, and coordination of future research visits Coordinate day-to-day clinical trial operations withing the procedural environment Serve as primary liaison among participants, investigators, clinical staff, sponsors, CROs, and imaging core labs Schedule and coordinate study visits procedures, imaging, laboratory testing, and follow-up appointments Prepare and manage investigational devices, procedural kits, and study supplies Support informed consent process per protocol and institutional policy Coordinate post-procedure monitoring, discharge instructions, and follow-up care Collect and document clinical assessments, labs, imaging, radiation exposure, and contrast use Track and report adverse events, serious adverse events, and unanticipated problems Provide patient education related to procedures, medications, and follow-up requirements Data Collection and Monitoring Participate in the design, development and testing of clinical research trials data systems 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 Collect, enter, and verify source data and electronic case report forms Ensure accurate documentation of procedural device, and imaging data Respond to data queries and maintain data quality Prepare for and participate in monitoring visits and audits Maintain drug/device accountability and reconciliation logs Regulatory Guidelines and Documents Manage and organize regulatory documentation from site 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 Maintain complete and up-to-date regulatory binders and investigator site files Prepare and submit IRB applications, amendments, continuing reviews, and safety reports Prepare and submit IRB applications, amendments, continuing reviews and safety reports Ensure compliance with GCP, FDA regulations, and institutional policies Maintain training and delegation documentation Support regulatory audits and inspections Protocol Development/Management and Study Responsibilities 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 Responsible for feasibility assessments and study start-up activities Review protocols for operational feasibility and workflow integration Coordinate site initiation, investigator meetings, and sponsor communications Track study milestones, enrollment targets, and budgets Responsible for study close-out activities and document archiving Human Resources/Leadership May provide functional and/or administrative supervision. Mentor new staff under direction Coordinate multidisciplinary teams and clinical workflows Support leadership with staffing, coverage planning, and resource needs 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

Requirements

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.

Nice To Haves

Ability to work independently and manage multiple priorities or studies at one time.
ACRP or SoCRA Certification
Experience with medical research data management
Experience working with Epic, RedCap, Clinicaltrials.gov and IRB submission systems.

Responsibilities

Research/Clinical Activities
Subject Recruitment and Enrollment Screen, recruit, consent, enroll, assess and monitor subjects for both general research and clinical trial projects.
Oversee the recruitment of subjects and scheduling off trial-related procedures
Educate study participants on the scope of the study, potential risks and benefits, possible alternatives, and requirements for participants
Relay information to the principal investigator and verify study participant eligibility
Identify potential participants through clinics, imaging reports, and procedure schedules
Conduct eligibility screening and maintain screening and enrollment logs
Coordinate and document informed and retention strategies
Maintain confidentiality and comply with HIPAA requirements
Participates in clinical research visits, which includes Epic documentation, checking vitals, precision of research questionnaires, patient education, and coordination of future research visits
Coordinate day-to-day clinical trial operations withing the procedural environment
Serve as primary liaison among participants, investigators, clinical staff, sponsors, CROs, and imaging core labs
Schedule and coordinate study visits procedures, imaging, laboratory testing, and follow-up appointments
Prepare and manage investigational devices, procedural kits, and study supplies
Support informed consent process per protocol and institutional policy
Coordinate post-procedure monitoring, discharge instructions, and follow-up care
Collect and document clinical assessments, labs, imaging, radiation exposure, and contrast use
Track and report adverse events, serious adverse events, and unanticipated problems
Provide patient education related to procedures, medications, and follow-up requirements
Data Collection and Monitoring
Participate in the design, development and testing of clinical research trials data systems
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
Collect, enter, and verify source data and electronic case report forms
Ensure accurate documentation of procedural device, and imaging data
Respond to data queries and maintain data quality
Prepare for and participate in monitoring visits and audits
Maintain drug/device accountability and reconciliation logs
Regulatory Guidelines and Documents
Manage and organize regulatory documentation from site 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
Maintain complete and up-to-date regulatory binders and investigator site files
Prepare and submit IRB applications, amendments, continuing reviews, and safety reports
Prepare and submit IRB applications, amendments, continuing reviews and safety reports
Ensure compliance with GCP, FDA regulations, and institutional policies
Maintain training and delegation documentation
Support regulatory audits and inspections
Protocol Development/Management and Study Responsibilities
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
Responsible for feasibility assessments and study start-up activities
Review protocols for operational feasibility and workflow integration
Coordinate site initiation, investigator meetings, and sponsor communications
Track study milestones, enrollment targets, and budgets
Responsible for study close-out activities and document archiving
Human Resources/Leadership
May provide functional and/or administrative supervision.
Mentor new staff under direction
Coordinate multidisciplinary teams and clinical workflows
Support leadership with staffing, coverage planning, and resource needs

Benefits

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

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