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 Bilingual Clinical Research Associate (French/English) – Canada Remote
Parexel is hiring a senior bilingual Clinical Research Associate to monitor clinical trials across Canada. The role manages site relationships, compliance, data quality, and study execution from site identification through close-out.
Descriere
- Conduct site qualification, initiation, monitoring, and termination visits at assigned clinical sites
- Prepare visit and contact reports
- Serve as the primary contact for building and maintaining clinical site relationships
- Investigate and resolve site questions and operational issues
- Protect study integrity and oversee site delivery from identification through close-out
- Assess trial performance and protect human-subject rights and well-being in line with study protocols
- Partner with clinical sites to create patient recruitment strategies that support enrollment timelines
- Maintain compliance with SOPs, protocols and amendments, GCP, and applicable regulatory requirements
- Assess reported-data quality and integrity, site performance, and investigational drug accountability
- Track the completeness and quality of regulatory documentation
- Verify site documentation
Cerințe
- At least 18 months of direct on-site monitoring experience as a Clinical Research Associate (CRA)
- Bachelor’s degree or equivalent in biological science, pharmacy, or another health-related field
- Strong interpersonal, written, and verbal communication skills for working within a matrixed team
- Ability to work independently, act with urgency, and operate with limited supervision
- Client-oriented mindset with flexibility toward assignments and continued learning
- Ability to prioritize multiple tasks, assess changing situations, meet project timelines, and apply study-protocol knowledge
- Consistently honest and ethical approach to work
- Strong computer proficiency, including Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), Microsoft Excel, and Microsoft Word
- Fluent written and spoken English and French
Beneficii
- Eligibility for a bonus incentive program
- Reduced travel and protocol workload compared with industry peers
- Access to advanced workplace technology
- Training tailored to individual experience
- Exposure to multiple therapeutic areas
- Opportunities for career advancement
- Ongoing career development through regular performance discussions and evaluations