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Deschide
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.
Senior Clinical Research Associate, Central or Western US
Oversee investigator sites and clinical trial monitoring for Parexel across the Central or Western United States. Support patient safety, GCP compliance, recruitment, and study quality throughout the trial lifecycle.
Descriere
- Oversee management, monitoring, and close-out of assigned clinical trial investigator sites.
- Protect patient safety and ensure high-quality study conduct in line with applicable laws, GCP, and sponsor standards.
- Manage investigator relationships and trial operations from site activation through database lock.
- Act as the primary contact for assigned investigator sites.
- Coordinate with Site Care Partners, study teams, vendors, and investigator sites.
- Support site development through coaching, training, and protocol guidance.
- Monitor sites onsite and remotely or electronically during initiation, routine follow-up, and closure.
- Track adverse events and serious adverse events in collaboration with the Drug Safety Unit.
- Submit TMF documents, site reports, follow-up letters, protocol deviations, recruitment updates, and study progress reports.
- Identify and address site issues, developing corrective and preventive actions as needed.
- Resolve data queries and carry out investigator site close-out activities.
- Oversee investigational product receipt, handling, accountability, storage, and destruction.
- Support database release and, where needed, conduct unblinded monitoring.
- Maintain knowledge of products, protocols, and relevant therapy areas.
- Support patient safety, eligibility assessments, and clinical guidance.
- Lead quality-event remediation and audit CAPA activities.
Cerințe
- Strong knowledge of clinical trial methods, ICH/GCP, FDA requirements, and local regulations.
- At least two years of relevant experience monitoring clinical research sites.
- Fluency in English and the native language or languages of the country of employment.
- Ability to travel 60–80% of the time.
- Valid driver's license and passport.
- Bachelor's degree in life sciences or an equivalent professional life sciences qualification, such as nursing, pharmacy, or medicine.
Beneficii
- Parexel is an equal opportunity employer.
- Contribute to therapies that benefit patients and advance global health.
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