Parexel
Senior Clinical Research Associate I/II - Sponsor Dedicated - Oncology Experience Needed
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Senior Clinical Research Associate (CRA) – EU Sponsor Trial Support
Location: EU (Large Sponsor Collaboration) Shared Purpose: At Parexel, we unite behind a single mission: to improve the world’s health. Every trial we support, from end-to-end development to market access, is driven by our unwavering commitment—patient safety, quality execution, and empathy are at its core. Regular, engaged interactions across sites, sponsors, and internal teams ensure tangible, measurable benefits for participants.
About the Role
As a Senior CRA, you will oversee site management, monitoring, and close-out of assigned clinical trials within a major EU-based Sponsor partnership. This role demands expertise in ensuring adherence to Study Monitoring Plans, GCP/ICH guidelines, local regulations (EU/FDA impacts), and patient safety—guiding studies from site activation to final database lock with precision.
Key Responsibilities
- Operational Execution
- Ensure clinical trials conduct in alignment with Study Monitoring Plans, ICH/GCP, and applicable laws across assigned sites.
- Manage end-to-end trial activities, from site activation through close-out, prioritising timeliness and quality deliverables.
- Facilitate seamless study team-culture integration, bridging gaps between sponsors, vendors, and CROs.
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Adverse Event (AE) & Adenosine Symptom Event (SAE) Stewardship
- Monitor and escalate AEs/SAEs in collaboration with Drug Safety Units.
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Audit Conduct & Risk Mitigation
- Serve as the audit liaison for assigned sites, proactively developing and resolving CAPAs from observed audit deficiencies.
- Close collaboration with audit teams to ensure compliance and remediation.
Who We Are
Parexel operates at the cutting edge of clinical research, partnering with clients across all therapeutic areas. Our legacy includes pioneering the trials that delivered over half of today’s top 50 drugs. Yet, beyond profit, we champion niche therapies critical for underserved patient populations. Our team embrace Parexel’s four core pillars: • Influence: from patient advocacy to industry leadership • Commitment: to ethical practices, deep expertise, and patient-first thinking
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About You
Experience & Qualifications
- Education: Bachelor’s (or equivalent professional degree) in Life Sciences (e.g., Nursing, Pharmacy, Medicine).
- Monitoring Expertise: Minimum 3.5 years as a GCP/CDA in:
- Site-based clinical trial monitoring (Oncology is a preferences).
- Familiarity with therapeutic areas: oncology, vaccines, infectious disease, or internal medicine.
- Regulatory & Process Mastery: Proficiency in ICH/GCP, FDA/EU regulations, and CRA best practices.
Attributes of Success
Parexel hires professionals with heart. Critical traits include:
- Patient-Centric Mindset: Putting ethical priorities above all else.
- Operational Execution: Raising stakeholder visibility at critical touchpoints.
- Collaboration: Effectively interfacing between sponsors, sites, and study teams.
Join Parexel: Bilateral Knowledge + Deep Commitment drive the next breakthroughs in clinical research. Together with Heart.™
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