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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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Delovna mesta v podjetju

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.

USZdružene države AmerikeMDMarylandVAVirginijaNa daljavoPolni delovni časJuniorSrednja ravenDiploma ni potrebnaZahtevani Jezik: angleščinaKlinične raziskave
Google Cloud Platform

Opis

  • 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.

Zahteve

  • 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.

Ugodnosti

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

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