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Parexel
Parexel
Sponsor pentru viza H1BAsistență medicalăConsultanțăLogistică
Parexel este o organizație globală de cercetare clinică ce deservește companii biofarmaceutice pe parcursul dezvoltării de medicamente noi. Activitatea sa acoperă studii clinice de fază I–IV, gestionarea portofoliilor și a studiilor, strategia de reglementare, accesul la piață și planificarea ciclului de viață. Cu peste 21.000 de profesioniști, Parexel îmbină expertiza clinică, de reglementare și terapeutică cu perspectivele pacienților și designuri inovatoare ale studiilor. Compania sprijină cercetarea în domenii precum oncologia, neuroștiințele și bolile rare, punând accent pe eficientizarea dezvoltării clinice și pe orientarea acesteia către pacienți.
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Locurile de muncă ale companiei

Clinical Research Associate, Oncology

Monitor oncology clinical trial sites for Parexel, a provider of clinical development, regulatory, consulting, and market access services. Oversee site compliance, participant safety and recruitment, and study documentation.

USStatele Unite ale AmericiiMDMarylandVAVirginiaRemoteNormă întreagăJuniorNivel mediuNu este necesară o diplomăLimbă Obligatorie: englezăCercetare clinică
Google Cloud Platform

Descriere

  • Serve as the primary site contact and manager throughout each clinical research study.
  • Build strong site relationships and maintain continuity across trial phases.
  • Manage and monitor clinical study sites in line with ICH/GCP, sponsor SOPs, applicable laws and regulations, protocols, and monitoring plans.
  • Develop a thorough understanding of study protocols and related procedures.
  • Coordinate with sponsor colleagues to prepare sites for readiness.
  • Contribute to site selection and validation.
  • Conduct remote and on-site monitoring and oversight.
  • Ensure site data are complete, accurate, and unbiased.
  • Safeguard participants’ rights, safety, and well-being.
  • Conduct validation, initiation, monitoring, and closeout visits, and submit accurate reports on time.
  • Collect, review, and track regulatory documents for study start-up, ongoing maintenance, and closeout.
  • Discuss protocol conduct, recruitment, retention, deviations, regulatory documents, audits and inspections, and site performance with investigators and site staff.
  • Identify, assess, resolve, and escalate site performance, quality, and compliance concerns.
  • Maintain study information and documentation in CTMS, eTMF, and other systems.
  • Share process expertise and best practices with the CRA team, including through buddying and mentoring.
  • Support or lead audits and inspections.
  • Conduct co-monitoring visits when appropriate.

Cerințe

  • Fluency in English and relevant local languages, spoken and written.
  • Sound knowledge of clinical research, trial phases, current GCP/ICH standards, and country-specific clinical research laws and guidance.
  • Good knowledge of global and country or regional clinical research guidelines.
  • Practical knowledge of Good Documentation Practices.
  • Demonstrated site management skills, including oversight of site performance and patient recruitment.
  • Strong monitoring skills and the ability to exercise independent professional judgment.
  • Proficiency with IT tools, including Microsoft Office and clinical applications.
  • Ability to interpret and analyze data and metrics.
  • Ability to handle complex issues and find practical solutions.
  • Skills in root cause analysis and preventive and corrective actions.
  • Strong time management, organization, interpersonal, conflict management, and problem-solving skills.
  • Ability to work independently across multiple protocols, sites, and therapy areas.
  • Ability to prioritize and manage several tasks at once.
  • Ability to work effectively in a multicultural, matrixed environment.
  • Commitment to customer focus, quality, and compliance.
  • Availability for domestic and international travel about 65%–75% of working time, typically 2–3 days per week.
  • Current driver’s license.
  • At least two years of direct site monitoring experience in biotechnology, pharmaceuticals, or a CRO.
  • Oncology monitoring experience.
  • Bachelor’s degree preferred, ideally with a strong science or biology focus.

Beneficii

  • Full-time employment.
  • Remote work arrangement.
  • Equal opportunity employment.

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