Clinical Research Associate

Rho

. Collect, track and review investigational site records relating to subject screening and enrollment .

Posted 11/4/2026full-timeRemote • United StatesJuniorMid-Level💰 $55,000 - $65,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical trial documentation, including Trial Master Files and regulatory submissions, while ensuring compliance with ICH/GCP guidelines and federal regulations. Strong communication and organizational skills are essential for effective collaboration with study teams and external stakeholders.

Highest-signal resume keywords

Clinical Trials Management System (CTMS)Trial Master File (TMF) ManagementICH/GCP Guidelines ComplianceRegulatory Document ManagementClinical Research Process Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Document ManagementData ReviewSite MonitoringInformed Consent Form DevelopmentStudy Plan Development

Soft Skills

Attention to DetailStrong Written CommunicationVerbal CommunicationPresentation SkillsProblem-Solving

Tools & Technologies

Project Tracking ToolsClinical Trials Management System (CTMS)

Industry Keywords

CROPharmaBiotechRegulatory SubmissionsEthics Submission Processes

About the role

Key responsibilities & impact

Collect, track and review investigational site records relating to subject screening and enrollment
Assist in the development of study plans and status reports
Collect, track, and review all site regulatory documents
Assist with development and review of Informed Consent Forms
Interact with sites, clients, vendors and internal study team members
Maintain the clinical trials management system (CTMS) and other project tracking tools
Track study supplies and coordinate shipments of supplies to sites as needed
Manage the study Trial Master File (TMF) and ensure periodic TMF audits
Coordinate work with CRAs monitoring on-site
Perform on site co-monitoring and remote monitoring activities
Perform regular reviews of data entered by investigational site staff according to data review/monitoring guidelines
Work with the Project Manager, traveling CRAs and Lead CRA to support clinical trial monitoring activities
Assist CRAs with query resolution and data reviews
Ensure studies operate in compliance with study protocols, Rho SOPs, ICH/GCP guidelines and federal regulations
Potentially mentor other team members

Requirements

What you’ll need

Bachelors Degree in a life science, nursing or pharmacy field
At least 1 year of direct work experience managing essential documents within the CRO, pharma or biotech industry
Good knowledge of clinical research process
Understanding of Regulatory and Central/Local ethic submission processes for assigned countries
Working knowledge of current ICH GCP guidelines and applicable regulations
Desire / Career Goal of growing into a traveling CRA role
Strong written, verbal and presentation skills
Attention to detail and understanding of high-quality scientific standards
Honesty and integrity
Ability to evaluate situations objectively and incisively and craft novel, practical solutions
Ability to change quickly and adapt to evolving environments

Benefits

Comp & perks

Medical insurance
Vision insurance
Dental insurance
HSA
FSA
EAP
Life insurance
Disability insurance
401(k)
Paid time off
Holidays
Parental leave
Bereavement leave
Work-life balance flexibility