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Parexel
Parexel
Sponzor vizuma H1BLogistikaSvetovanjeZdravstveno varstvo
Parexel je globalna organizacija za klinične raziskave, ki biofarmacevtskim podjetjem pomaga pri razvoju novih zdravil. Njeno delo zajema klinične raziskave faz I–IV, upravljanje portfeljev in raziskav, regulativno strategijo, dostop do trga ter načrtovanje življenjskega cikla. Z več kot 21.000 strokovnjaki Parexel združuje klinično, regulativno in terapevtsko znanje z vpogledi v potrebe pacientov ter inovativnimi zasnovami raziskav. Podjetje podpira raziskave na področjih, kot so onkologija, nevroznanost in redke bolezni, s poudarkom na učinkovitejšem kliničnem razvoju, osredotočenem na paciente.
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Senior Clinical Research Associate, Contractor – Australia

Monitor clinical trial sites across Australia for Parexel, overseeing protocol compliance, data quality, documentation, and trial deliverables. This contractor role covers site activities from study initiation through closeout.

AUAvstralijaNa daljavoPolni delovni časSeniorZahtevani Jezik: angleščinaKlinične raziskave
Google Cloud Platform

Opis

  • Serve as Parexel’s primary contact for assigned clinical sites throughout each study.
  • Verify sound study implementation and protocol compliance at sites, and resolve site issues.
  • Build effective working relationships with investigators and site staff.
  • Coordinate access to study systems and confirm completion of project-specific training.
  • Review site staff assignments and arrange corrective actions and follow-up as needed.
  • Resolve issues involving training, documentation, communications, and findings from prior visits.
  • Assess data quality and integrity concerns, then coordinate appropriate follow-up.
  • Attend investigator and project meetings, audits, and regulatory inspections.
  • Collect, review, and approve current site and regulatory documents.
  • Review site recruitment plans and recommend ways to improve recruitment.
  • Conduct qualification, initiation, on-site, and remote site visits or contacts.
  • Prepare reports documenting site visits and contacts.
  • Assess site compliance and performance, and recommend actions tailored to each site.
  • Oversee study supplies, including accountability and return or destruction status.
  • Track site payments, CRF entry, data queries, and serious adverse events (SAEs), following up as needed.
  • Deliver study-specific on-site training when required.
  • Assess site facilities.
  • Report non-compliance, issues, delays, and changes, together with proposed resolutions.
  • Complete project objectives and update relevant trial management systems.
  • Work with project colleagues on plans, objectives, and deliverables.
  • Maintain CTMS records and review site data in CTMS, EDC, IVRS, and SIS.
  • Maintain relevant Trial Master File documents and distribute study materials to sites.
  • Keep assigned sites ready for audits and inspections.
  • Follow ICH-GCP and applicable international and local regulations.
  • Delegate and oversee administrative work, providing performance feedback.
  • Deliver high-quality work and maintain collaborative relationships in a matrix team.
  • Keep the manager updated on progress and issues.
  • Build subject-matter expertise.
  • Submit timesheets, expenses, metrics, and other assigned work.
  • Serve as Parexel’s primary contact for assigned clinical sites throughout each study.

Zahteve

  • Applicants should be freelance CRAs with about five or more years of CRA experience, based in NSW, VIC, SA, or QLD; NSW and VIC are preferred.
  • Australian CRA experience is required.
  • Oncology experience is preferred.
  • Site management experience, or equivalent clinical research experience with knowledge of clinical trial methods and terminology.
  • Degree in biological science, pharmacy, or another health-related field; equivalent nursing qualification or experience is also accepted.
  • Strong problem-solving skills.
  • Able to work independently, take initiative, and seek guidance when needed.
  • Advanced presentation skills.
  • A client-focused approach.
  • Professional communication within client organizations.
  • Flexibility with assignments and readiness to learn.
  • Able to prioritize competing tasks, meet project timelines, and make autonomous decisions using analytical skills.
  • Comfort working in a matrix structure and collaborating with a team.
  • Strong computer skills, including CTMS, EDMS, Microsoft Excel, and Word.
  • Strong interpersonal, verbal, and written communication skills.
  • Able to support study and country deliverables while safeguarding patient safety.
  • Effective time management.
  • Developing cross-cultural working skills.
  • Able to work effectively in a virtual team.
  • Excellent attention to detail.
  • Able to meet extensive travel requirements.
  • Valid driver's license where required.

Ugodnosti

  • Independent contractor engagement for 6 to 12 months; the duration will be determined later.
  • Full-time role.

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