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Alira Health
Alira Health
501 – 1.000 Angajați
Sponsor pentru viza H1BAsigurare de sănătateAsistență medicalăIndustria prelucrătoare
Alira Health este o companie globală de consultanță și tehnologie în domeniul sănătății, care oferă servicii organizațiilor din domeniul științelor vieții. Activitatea sa acoperă cercetarea și dezvoltarea clinică, conformitatea cu reglementările, consultanța managerială, implicarea pacienților și accesul pe piață, precum și soluții tehnologice concepute pentru a sprijini cercetarea în științele vieții. Compania pune accent pe empatie, excelență științifică, rezultate mai bune pentru pacienți, sustenabilitate ecologică, implicare comunitară și inițiative ESG.
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Clinical Research Associate - Massachusetts Remote - Alira Health

Monitor clinical trials for Alira Health’s global healthcare research team, supporting protocol compliance, site quality, regulatory documentation, and reliable clinical data.

USStatele Unite ale AmericiiMAMassachusettsRemoteNormă parțialăJuniorNivel mediuLimbă Obligatorie: englezăCercetare clinică
Google Cloud Platform

Descriere

  • Conduct clinical trial site monitoring activities
  • Oversee and guide clinical trial management and execution to support compliance and quality
  • Guide and provide feedback to the CRA team on project scope, SOPs, timelines, and budgets
  • Review monitoring visit reports and complete co-monitoring and evaluation visits when needed
  • Ensure investigator site visits are completed appropriately and on schedule
  • Coordinate cross-functional teams to resolve clinical trial monitoring issues
  • Support study-specific Monitoring Plans and training presentations
  • Help collect ethics documents and negotiate site contracts
  • Submit monthly billing information to the finance team
  • Manage study budgets and serve as the sponsor contact for stand-alone projects
  • Conduct qualification, initiation, interim, and close-out visits remotely and onsite
  • Prepare complete and timely monitoring visit reports
  • Review and verify source documents and CRF data
  • Perform quality control and verification of eTMF and TMF documentation
  • Maintain investigational product accountability
  • Review site regulatory binders
  • Communicate with study sites about protocol and GCP compliance, patient accrual, and sponsor requests
  • Maintain compliance with ICH GCP, FDA regulations, and company or sponsor SOPs
  • Participate in internal, client or sponsor, scientific, and other meetings
  • Facilitate adverse event reporting and reconcile SAE reports against source documents and CRFs
  • Work with in-house CRAs, CTC, and data management to resolve discrepant data queries
  • Identify site issues and develop effective resolution strategies
  • Prepare study sites for audits as required
  • Partner with other CRAs to promote consistency and teamwork
  • Support CRA new-hire training and onboarding
  • Mentor CRAs
  • Contribute to the development and maintenance of the Clinical Trial Management System (CTMS)
  • Balance competing priorities and deliver on commitments
  • Complete other assigned duties

Cerințe

  • Graduation in a scientific health field for EU-based roles
  • For Italy-based EU roles, certification as a Monitor compliant with the Italian CRO decree dated 15 November 2011
  • Ability to build and maintain positive relationships with sponsors, sites, and project team members
  • Ability to manage monitoring activities independently
  • Quality-focused approach with demonstrated care, thoroughness, and attention to detail
  • Strong organization skills, with the ability to multitask and work effectively in a fast-paced environment
  • Ability to prioritize, manage time, and solve problems
  • Strong analytical, negotiation, meeting management, cross-functional collaboration, and leadership skills
  • Willingness and ability to travel
  • Ability to manage stress effectively
  • Professional, trustworthy, and disciplined approach
  • Ability to solve unstructured or ambiguous problems
  • Strong written and verbal command of the local language in the country where monitoring activities are performed
  • Excellent communication and interpersonal skills with a customer-service orientation
  • Proficiency with computers, including clinical trial management systems, clinical trial databases, and electronic data capture tools
  • Self-motivated and effective in a collaborative, less structured team environment
  • Knowledge of clinical research, ICH GCP, and local regulations
  • Knowledge of regulatory and ethical requirements
  • Adequate English proficiency for EU-based roles
  • Bachelor of Science degree in Biology or Life Sciences

Beneficii

  • Remote work arrangement
  • Part-time employment
  • Contingency workforce contract

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