Clinical Research Associate II/III (Belgrade, Serbia)
Optimapharm · Belgrade
Description du poste
About the role
Optimapharm is seeking a Clinical Research Associate (CRA II or III) to join its Belgrade team. The CRA will independently monitor clinical trials, ensuring compliance with protocol, regulatory standards and patient safety while supporting the delivery of innovative therapies.
Key responsibilities
- Conduct routine site visits (pre‑study, initiation, interim monitoring, close‑out) independently.
- Maintain regular contact with site personnel to ensure compliance, adequate enrolment and understanding of study requirements.
- Perform source data verification, review CRFs, generate and resolve data queries according to established guidelines.
- Identify and escalate potential risks, propose corrective and preventive actions, and arrange retraining for site staff when needed.
- Prepare and maintain accurate monitoring reports and documentation.
Required profile
- University degree in medical or life sciences (nursing or related healthcare degree acceptable).
- 1‑2 years of independent clinical trial monitoring experience (oncology experience a plus).
- Strong knowledge of ICH GCP guidelines and local regulatory requirements.
- Fluent in Serbian and English, both written and spoken.
- Excellent communication, interpersonal and negotiation skills.
- Proactive, able to work independently in a matrix environment.
- Valid driver’s licence.
Required skills
- ICH GCP Guidelines
- Regulatory requirements
- Clinical trial monitoring
- CRF review and data query management
- Computer proficiency (e.g., MS Office)
What we offer
- Competitive performance and referral bonuses.
- Flexible working hours and remote work options.
- Company car and additional health insurance.
- Employee engagement, well‑being initiatives and training programmes.
- Opportunity to work in a growing global CRO with exposure to diverse therapeutic areas.
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Optimapharm
Belgrade
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