Lead CRA Poland

📍
Location
:
Poland - Office based
🕓 Type
:
Full-time

Do you want to protect the safety & well-being of subjects and guarantee data quality? Do you get energy from daily communication with investigators, study coordinators and study teams? Do GCP ICH E6 R2 and ISO 14155 have no secrets anymore for you? Do you like to perform monitoring visits in hospitals and wantto protect the safety & well-being of subjects and guarantee data quality?

You might be the Lead Clinical Research Associate we are looking for at QbD Clinical!

• Develop and execute monitoring plans through protocol analysis for remote risk management.
• Prepare for and conduct regular Site Compliance Meetings, reviewing KRI’s and any associated action items.
• Ensure GCP compliance for monitoring clinical trials, including the implementation of future monitoring approaches.
• Evaluate the development of monitoring plans and employ efficient and accurate strategies for monitoring clinical trials.
• Collaborate with clinical KOLs and internal teams to manage clinical strategy.
• Utilize technology-enabled tools and risk evaluation approaches for remote monitoring.
• Provide training to monitoring team and support to site personnel to ensure high-quality data collection and regulatory compliance.
• Continually monitor data and analyze findings to decide whether to conduct a remote or targeted on-site monitoring visit.
• Review oversight of monitors and ensure adherence to service level agreements and legal and regulatory standards.
• Represent Site Management in Study Core team meetings.
• Collaborate with Study team as needed for audit response or site corrective action plan.

• Master or Bachelor degree in biological or (para-) medical sciences or equivalent by experience.
• Minimum of 3 years’ experience in clinical research in a CRO or hospital setting.
• Fluent in Polish and English. Other languages are a big asset.
• In-depth knowledge of RBM strategies.
• Willing to travel internationally (