Initiation Clinical Research Associate I or II

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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