Clinical Trials Research Associate - Radiology

Position Responsibilities

• Research/Clinical Activities
• Subject Recruitment and Enrollment

Responsible for assisting with the design, development, implementation, administration, and maintenance of clinical trial protocols while ensuring compliance with regulatory and institutional requirements.

Screening, recruiting, consenting, enrolling, assessing and monitoring subjects for both general research and clinical trial projects.

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

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

Verifies study participant eligibility by identifying potential participants through clinics, imaging reports, and procedure schedules.

Maintains confidentiality and comply with HIPAA requirements.

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.

Aids in the 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.

Data Collection and Monitoring

• Participates in the design, development and testing of clinical research trials data systems
• Validates data, query resolution, and makes recommendations for resolution
• Revise and implement changes in data collection
• Coordinates the processing of data from various sites/centers/studies
• Captures, 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

Regulatory Guidelines and Documents

• Manages and organizes regulatory documentation from site and regulatory authorities
• Prepares regulatory submissions
• Performs on-site audits of research and clinical data
• Maintains compliance with regulatory guidelines and proper maintenance of documents
• Makes recommendations for corrective action for reportable events
• Communicates 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
• Maintains training and delegation documentation
• Supports regulatory audits and inspections

Protocol Development/Management and Study Responsibilities

• Assists in the design, development, execution administration, and maintenance of protocols and clinical studies
• Assists in study design and protocol development and provides input into descriptions of complex research procedures
• Reviews query reports
• Solves 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
• Maintains protocol status as it is processed through the IRB
• Coordinates site initiation, investigator meetings, and sponsor communications
• Tracks study milestones, enrollment targets, and budgets
• Conducts study close-out activities and document archiving

Human Resources/Leadership

• 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