LogoFresh Jobs Ahead
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.
LinkedIn
Locurile de muncă ale companiei

Clinical Research Associate - Massachusetts Remote

Monitor clinical trials for Alira Health’s global research team. Support protocol compliance, site quality, data integrity, and regulatory adherence.

USStatele Unite ale AmericiiMAMassachusetts
110.000 $ – 130.000 $ / an
RemoteNormă întreagăJuniorNivel mediuLimbă Obligatorie: englezăCercetare clinică
Google Cloud Platform

Descriere

  • Monitor clinical trial sites and support study oversight.
  • Provide leadership and guidance across clinical trial management and execution.
  • Maintain protocol compliance and study quality.
  • Review monitoring visit reports and complete co-monitoring and evaluation visits when needed.
  • Ensure investigator site visits occur on schedule.
  • Coordinate with cross-functional teams to resolve clinical trial monitoring issues.
  • Support study-specific monitoring plans and training presentations.
  • Assist with ethics document collection and site contract negotiations.
  • Submit monthly billing information to Finance.
  • Manage study budgets and serve as sponsor referent for standalone projects.
  • Conduct qualification, initiation, interim, and close-out visits remotely and onsite.
  • Document site issues, resolutions, protocol deviations, study progress, and enrollment in monitoring visit reports.
  • Review and verify source documents and CRF data.
  • Perform quality control and verification of eTMF/TMF documentation.
  • Track investigational product accountability.
  • Review site regulatory binders.
  • Communicate with study sites about protocol and GCP compliance, accrual, and sponsor requests.
  • Maintain compliance with ICH GCP, FDA regulations, and SOPs.
  • Facilitate adverse-event reporting and reconcile SAE reports against source documentation and CRFs.
  • Resolve discrepant-data queries with in-house CRAs/CTC and Data Management.
  • Identify site issues and develop practical resolution strategies.
  • Prepare study sites for audits.
  • Support CRA training and onboarding and mentor CRAs.
  • Contribute to CTMS development and maintenance.
  • Balance competing priorities while meeting commitments.

Cerințe

  • At least two years of clinical trial monitoring experience.
  • Ability to build and maintain positive relationships with sponsors, sites, and project team members.
  • Ability to manage monitoring activities independently.
  • Quality-focused approach with proven care, thoroughness, and attention to detail.
  • Strong organizational skills and the ability to multitask effectively in a fast-paced environment.
  • Ability to prioritize tasks, 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 working style.
  • 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.
  • Knowledge of clinical research, ICH GCP, and applicable local regulations.
  • Knowledge of regulatory and ethical requirements.
  • Bachelor’s degree in Biology, Life Sciences, or equivalent education.

Locuri de muncă similare