🕒 17 days ago
Conduct onsite monitoring across clinical studies, oversee site communication and study progress, review clinical data, support study startup and regulatory submissions, and contribute to audits and inspections.
Clinical Research Associate
🕒 17 days ago
Clinical Research MonitoringOnsite Monitoring VisitsStudy StartupCRF Review
📜 Description
- Conduct and report onsite monitoring visits across clinical studies.
- Support study startup and participate in feasibility research.
- Review CRFs, verify source documents, and resolve queries.
- Manage site communications and coordinate with support services, vendors, and internal project teams.
- Support regulatory document preparation for study submissions.
- Participate in audits and inspections.
🛠️ Requirements
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- The candidate should meet the requirements for a CRA/monitoring position in Bosnia and Herzegovina
- At least 1 year of independent on-site monitoring experience
- Experience in all types of monitoring visits
- Full working proficiency in English and Serbian
- Proficiency in MS Office applications
- Ability to plan, multitask and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
- Ability to travel across the region
- Valid driver’s license
✨ Benefits
- Stability, long-term cooperation
- Permanent contract, full-time job
- Remote work setting
- Car allowance, laptop and mobile phone
- Career development
- Unique combination of team collaboration and independent work
- Friendly and supportive colleagues
- Onboarding courses about clinical research industry
Full job description
Company Description
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Job Description
As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.
You will:
- Conduct and report all types of onsite monitoring visits
- Be involved in study startup
- Perform CRF review, source document verification and query resolution
- Be responsible for site communication and management
- Be a point of contact for in-house support services and vendors
- Communicate with internal project teams regarding study progress
- Participate in feasibility research
- Support regulatory team in preparing documents for study submissions
- Support and participate in audits and inspections
Qualifications
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- The candidate should meet the requirements for a CRA/monitoring position in Bosnia and Herzegovina
- At least 1 year of independent on-site monitoring experience
- Experience in all types of monitoring visits
- Full working proficiency in English and Serbian
- Proficiency in MS Office applications
- Ability to plan, multitask and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
- Ability to travel across the region
- Valid driver’s license
Additional Information
What We Offer:
- Stability, long-term cooperation
- Permanent contract, full-time job
- Remote work setting
- Car allowance, laptop and mobile phone
- Career development
- Unique combination of team collaboration and independent work
- Friendly and supportive colleagues
- Onboarding courses about clinical research industry
- Mentoring and on-the job training
- Comfortable office and team support in Banja Luka
This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.
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