Senior CRA

Position Overview

• Location Type: Remote
• Employment Type: Full Time
• Salary: Not specified

The Sr CRA is a key member of the Alira Health Clinical team, responsible for conducting site monitoring responsibilities for clinical trials. This role requires a highly motivated individual who can function independently and provide oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The Sr CRA collaborates closely with various teams, including US: Director of Clinical Monitoring, Lead CRAs, in-house CRAs, EU: Associate Director of Clinical Monitoring, CRAs, and Project Managers.

Requirements

• Highly motivated and able to function independently.
• Strong understanding of clinical trial monitoring principles and GCP guidelines.
• Experience with ICH GCP, FDA regulations, and company/Sponsor SOPs.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a remote environment.
• Detail-oriented with a strong focus on accuracy and quality.

Responsibilities

• Guidance and Oversight:
  • Offers guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.
  • Reviews monitoring visit reports and conducts co-monitoring and evaluation visits as needed.
• Site Management:
  • Ensures appropriate and timely investigator site visits.
  • Coordinates with cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related 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.
• Budget Management (for Stand-Alone Projects):
  • Manages study budget and acts as referent for the sponsor.
• Monitoring Visits:
  • Performs qualification, initiation, interim, and close-out visits both remotely and onsite.
  • Ensures proper documentation of monitoring visits.
• Data Integrity:
  • Prepares consistently accurate and timely monitoring visit reports.
  • Ensures integrity of CRF data through meticulous and thorough source document review and verification.
  • Performs quality control and verification of documents collected at sites for eTMF/TMF.
• Regulatory Compliance:
  • Conducts investigational product accountability.
  • Reviews site regulatory binder for required documents.
• Communication & Reporting:
  • Maintains regular contact with study sites to ensure protocol/GCP compliance.
  • Assesses patient accrual rates and responds to sponsor requests.
  • Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs.
• Collaboration:
  • Participates in internal, client/sponsor, scientific, and other meetings as required.

Application Instructions

• Not specified.

Company Information

• Company: Alira Health
• Team: Clinical Team
• Company Culture: Focus on innovation and initiative, with a collaborative environment.