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 (CRA II) – Parexel, Remote United States
Monitor oncology and specialty clinical trials remotely for Parexel as a Clinical Research Associate. Oversee sites, compliance, recruitment, data quality, and participant safety.
Descriere
- Manage clinical sites from identification through closeout
- Act as the primary contact for assigned clinical site teams
- Conduct qualification, site initiation, monitoring, and termination visits
- Complete visit and contact reports promptly
- Maintain site quality and delivery across the study lifecycle
- Resolve site questions and issues to support study execution
- Protect study integrity while building investigator and site staff relationships
- Assess trial performance and protect participant rights, safety, and well-being
- Create patient recruitment strategies with clinical sites to meet enrollment timelines
- Maintain compliance with SOPs, study protocols and amendments, Good Clinical Practice, and regulatory requirements
- Assess reported data quality and integrity, site performance, and investigational product accountability
- Track the completeness and quality of regulatory documentation
- Verify site documentation
- Perform onsite monitoring and support enrollment and study delivery
Cerințe
- At least 18 months of direct onsite monitoring experience as a Clinical Research Associate
- Required experience monitoring oncology, ophthalmology, metabolic, hematology, or CAR-T clinical trials
- Bachelor's degree or equivalent in biological science, pharmacy, or another health-related discipline
- Working knowledge of Good Clinical Practice, applicable regulations, and clinical trial processes
- Experience with Clinical Trial Management Systems, Electronic Document Management Systems, and Microsoft Office, including Excel and Word
- Strong site relationship management, problem-solving, communication, interpersonal, written, verbal, organizational, and detail-oriented skills
- Able to work independently with urgency and limited supervision
- Able to manage competing priorities, assess changing situations, apply study protocols, and meet project deadlines
- Able to collaborate within a matrixed team and communicate clearly with internal and external stakeholders
- Ethical, patient-centered approach
- Client-focused and adaptable approach to assignments, with a commitment to continuous learning
Beneficii
- Health, vision, and dental insurance
- Tuition reimbursement
- Vacation, holiday, and sick time
- Flexible spending and health savings accounts
- Work-life balance
- 401(k) with company match
- Pet insurance
- Paid time off
- Life insurance
- Additional benefits provided under applicable plan terms
- Potential eligibility for additional incentives, bonuses, or other compensation programs