Travel Clinical Research Associate

Position Overview

• Location Type: Remote
• Job Type: Full Time
• Salary: Not provided

A dedicated member of the Alira Health Clinical team, the Clinical Research Associate (CRA) plays a vital role in ensuring the successful execution of clinical trials. This role requires a highly motivated individual who can work independently and contribute to a collaborative, global team environment. The CRA will be responsible for site monitoring, providing oversight, and ensuring compliance with protocols and regulations.

Requirements

• Strong understanding of clinical trial regulations (e.g., ICH GCP, FDA).
• Experience with clinical trial monitoring activities (e.g., co-monitoring, evaluation visits).
• Ability to conduct thorough source document review and verification.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Familiarity with electronic data capture (EDC) systems and electronic trial master file (eTMF) systems is a plus.

Responsibilities

• Provides guidance, oversight, and feedback to the CRA team.
• Conducts co-monitoring and evaluation visits as needed.
• Ensures appropriate and timely investigator site visits.
• Coordinates with cross-functional departments to resolve clinical trial monitoring issues.
• Assists in development of study-specific Monitoring Plans and training presentations.
• Assists in set up/collection of site specific ethics documents and site contract negotiation.
• Provides monthly billing information to the finance team.
• Manages study budget and acts as referent for the sponsor (for monitoring stand-alone projects).
• Performs qualification, initiation, interim, and close-out visits.
• Prepares monitoring visit reports documenting site-related problems, resolutions, and study progress.
• Ensures integrity of CRF data through meticulous source document review.
• Performs quality control and verification of documents collected at sites for eTMF/TMF.
• Conducts investigational product accountability.
• Reviews site regulatory binder for required documents.
• Maintains regular contact with study sites to ensure protocol compliance and assess patient accrual.
• Complies with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs.
• Participates in meetings as required.
• Facilitates adverse event reporting and resolves data queries.
• Proactively identifies site issues.

Application Instructions

• Not provided

Company Information

• Not provided