Conduct onsite clinical study monitoring and manage site relationships, timelines, and compliance across Phase II and/or III research, supporting study startup, data quality, and regulatory submissions.
Senior Clinical Research Associate
📜 Description
- Conduct and report onsite monitoring visits.
- Review CRFs and source documents, verify data, and resolve queries.
- Manage communication and relationships with clinical sites and investigators.
- Oversee site study activities, timelines, and schedules.
- Coordinate with in-house support services and vendors.
- Support quality control through compliance monitoring and report review.
🛠️ Requirements
- BSc or MSc in Life Sciences (or similar), or an equivalent combination of education, training & experience
- Independent on-site monitoring experience in Slovakia
- Demonstrable experience in all types of monitoring visits in Phase II and III
- Fluency in Slovak and English
- Experience supporting Oncology and Gastroenterology studies is beneficial
- Valid driver's license and the ability to travel
- Intermediate to Advanced knowledge of MS Office
- Communication, collaboration, and problem-solving skills are essential
Full job description
Company Description
PSI is a leading Contract Research Organisation with 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 Senior CRA, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. Your focus will be on subjects’ rights, safety and well-being and quality of data compliance.
This is a freelance (contractor) home-based position from within Slovakia.
Your responsibilities will include:
- Conducting and reporting all types of onsite monitoring visits
- Performing CRF reviews, source document verification and query resolution
- Be responsible for site communication and management
- Supervising study activities, timelines, and schedules for each site
- Acting as a point of contact for in-house support services and vendors
- Supporting quality control, such as compliance monitoring and reports review
Qualifications
- BSc or MSc in Life Sciences (or similar), or an equivalent combination of education, training & experience
- Independent on-site monitoring experience in Slovakia
- Demonstrable experience in all types of monitoring visits in Phase II and III
- Fluency in Slovak and English
- Experience supporting Oncology and Gastroenterology studies is beneficial
- Valid driver's license and the ability to travel
- Intermediate to Advanced knowledge of MS Office
- Communication, collaboration, and problem-solving skills are essential
Additional Information
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way. We will guide and support you with information, making your experience as smooth as possible.
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