Clinical Trials Research Associate/Assistant - Radiology

The University of Iowa Health Care Department of Radiology is hiring a Clinical Trials Research Associate/Assistant to support the planning, coordination, and execution of clinical research studies and trials. The role supports participant recruitment and enrollment, study operations, data and regulatory documentation, and protocol management to advance patient care and medical research.

Responsibilities

Educates study participants on the scope of the study, potential risks and benefits, possible alternatives, and requirements for participants

Screens, recruits, consents, enrolls, assesses and monitors subjects for both general research and clinical trial projects

Oversees the recruitment of subjects and scheduling off trial-related procedures

Educates study participants on the scope of the study, potential risks and benefits, possible alternatives, and requirements for participants

Relays information to the principal investigator and verify study participant eligibility

Identifies potential participants through clinics, imaging reports, and procedure schedules

Conducts eligibility screening and maintain screening and enrollment logs

Coordinates and documents informed and retention strategies

Maintains 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

Coordinates day-to-day clinical trial operations withing the procedural environment

Serves as primary liaison among participants, investigators, clinical staff, sponsors, CROs, and imaging core labs

Schedules and coordinates study visits procedures, imaging, laboratory testing, and follow-up appointments

Prepares and manages investigational devices, procedural kits, and study supplies

Supports informed consent process per protocol and institutional policy

Coordinates post-procedure monitoring, discharge instructions, and follow-up care

Collects and documents clinical assessments, labs, imaging, radiation exposure, and contrast use

Tracks and reports adverse events, serious adverse events, and unanticipated problems

Provides patient education related to procedures, medications, and follow-up requirements

Participates in the design, development and testing of clinical research trials data systems

Validates data, query resolution, and make recommendations for resolution

Revises and implements change in data collection

Coordinates the processing of data from various sites/centers/studies

Collects, enters, and verifies source data and electronic case report forms

Ensures accurate documentation of procedural device, and imaging data

Responds to data queries and maintain data quality

Prepares for and participates in monitoring visits and audits

Maintains drug/device accountability and reconciliation logs

Manages and organizes regulatory documentation from site and regulatory authorities; Prepares regulatory submissions

Performs on-site audits of research and clinical data

Monitors compliance with regulatory guidelines and proper maintenance of documents

May recommend corrective action for reportable events

May communicate with IRB staff and investigators

Maintains complete and up-to-date regulatory binders and investigator site files

Prepares and submits IRB applications, amendments, continuing reviews, and safety reports

Ensures compliance with GCP, FDA regulations, and institutional policies

Maintains training and delegation documentation

Supports regulatory audits and inspections

Assists in the design, development, execution administration, and maintenance of protocols and clinical studies

Assists in study design and protocol development and provide input into descriptions of complex research procedures

Oversees CRF development

Reviews query reports

Resolves all monitoring visit issues

Performs and monitors randomizations

Develops complex study materials

Serves as a liaison to local health care practitioners, agencies, and sponsors

Manages and maintains protocols

Researches, changes, and submits 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

Conducts training of new protocols and changes to existing protocols

Completes feasibility assessments and study start-up activities

Reviews protocols for operational feasibility and workflow integration

Coordinates site initiation, investigator meetings, and sponsor communications

Tracks study milestones, enrollment targets, and budgets

Conducts study close-out activities and document archiving

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

Coordinates multidisciplinary teams and clinical workflows

Prepares for and participates in monitoring visits and audits

Supports leadership with staffing, coverage planning, and resource needs

Preferred

Experience with research protocol management

Experience with protocol and medical research data management

Experience and participation with clinical trials

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

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

Knowledge of IRB regulatory guidelines and procedures

ACRP or SoCRA Certification

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

Clinical Trial Experience

Epic

REDCap

ClinicalTrials.gov

IRB Submission Systems

Blood Draws

IV Placement

Specimen Processing

Specimen Storage

Laboratory Maintenance

Inventory Management

Supply Ordering

IRB Procedures

ACRP Certification

SoCRA Certification

Independent Work

Prioritization

Multitasking

Benefits

Regular salaried position located in Iowa City, Iowa

Paid vacation

Sick leave

Health insurance options

Dental insurance options

Life insurance options

Disability insurance options

Generous employer contributions into retirement plans

Company

Teaching hospital providing specialized medical care

Iowa City, Iowa, USA

https://uihc.org/

Founded in 1875

0-1 employees

Qualifications

A Bachelor's degree in STEM (Science, Technology, Engineering, or Math) or related educational field, or an equivalent combination of education and experience

6 months of clinical research experience

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

Excellent written, verbal communication, interpersonal and organizational skills

2-4 years experience with and participation on clinical trials

Experience with research protocol management

Knowledge of IRB regulatory guidelines and procedures

Experience with medical research data management

Experience with protocol and medical research data management

Experience and participation with clinical trials

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

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

ACRP or SoCRA Certification

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

Required skills

Clinical Research, Clinical Trials, Research Protocol Management, IRB Regulatory Guidelines and Procedures, Medical Research Data Management, Microsoft Office, Adobe Acrobat, Epic, REDCap, ClinicalTrials.gov, ACRP or SoCRA Certification, Blood Draws and IV Placement

Preferred skills

Experience and participation with clinical trials

Experience

1+ years