Initiation Clinical Research Associate I or II
Serbia, Remote 职位编号 R0000042462 类别 Clinical Trials关于这个职位
About the Role
We're looking for an Initiation Clinical Research Associate to lead the startup and activation phase of clinical trials. You'll be the key point of contact between Parexel and our clinical sites, driving strategy from site identification through activation while ensuring regulatory compliance and first-time quality across all deliverables.
The roles is based remotely in Serbia, so you must reside in Serbia and have the right to work there.
Second languages preferable (French, Poland, Danish, Swedish, Finnish, Hungarian, Spanish)
What You'll Do
Own site startup: Build strong relationships with investigators and site staff, manage qualification visits, and guide sites through regulatory approvals (IRB/IEC, MoH/RA)
Drive regulatory excellence: Prepare and negotiate ICFs, manage protocol amendments, and ensure all documentation meets regulatory requirements
Ensure readiness: Coordinate training, system access, and compliance checks so sites launch on time and audit-ready
Manage the details: Maintain CTMS and eTMF records with first-time quality; resolve site issues proactively
Think strategically: Forecast timelines, identify risks early, and develop solutions independently
Who You Are
Self-driven problem-solver who takes initiative and works independently
Strong communicator with excellent interpersonal skills
Organized multi-tasker who thrives in a matrix environment
Detail-oriented with proven clinical research experience
Proficient in CTMS, eTMF, and MS Office
Comfortable working across cultures and virtual teams
What We're Looking For
Level II: Substantial startup experience in clinical research
Level I: Some startup experience or knowledge of in clinical research
Degree in biological science, pharmacy, nursing, or health-related field (or equivalent experience)
Knowledge of ICH-GCP guidelines and clinical trial methodology
Proficient in Serbian language
Second languages preferable (French, Poland, Danish, Swedish, Finnish, Hungarian, Spanish)
Ability to make sound decisions in ambiguous situations and work with urgency
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