Clinical Research Associate- Wound Care Job at Alira Health in boston

Responsibilities: Guide and coach the CRA team to meet project scope, SOPs, timelines, and budget Review monitoring visit reports and conduct co-monitoring and evaluation visits Schedule and ensure timely investigator site visits Coordinate with cross-functional departments to resolve monitoring-related issues Assist in developing study-specific Monitoring Plans and training materials Assist in ethics document setup and site contract negotiation Provide monthly billing information to Finance Manage budgets for monitoring stand-alone projects and serve as sponsor reference Perform qualification, initiation, interim, and close-out visits remotely and onsite Prepare monitoring reports detailing problems, resolutions, and enrollment status Ensure data integrity through source document review and CRF verification Verify eTMF/TMF documents and perform QA checks Conduct investigational product accountability Review site regulatory binders for required documents Maintain regular site contact to ensure protocol/GCP compliance and monitor accrual Ensure compliance with ICH GCP, FDA regulations, and SOPs Participate in meetings and assist with CRA onboarding and mentoring Collaborate on CTMS development and maintenance Manage competing priorities and adapt to evolving requirements

Key requirements: 2+ years wound care monitoring experience Ability to autonomously manage monitoring activities Strong organizational and multitasking abilities Excellent analytical, negotiation, and leadership skills Effective written and verbal communication in English Comfort traveling as required Knowledge of ICH GCP and local regulatory requirements Experience with CTMS, eTMF/TMF, and clinical trial databases strong communication and interpersonal skills leadership and mentoring problem-solving and adaptability clinical trial management systems (CTMS) eTMF/TMF document management clinical trial databases