Senior CRA II - Dedicated Sponsor Pipeline (Poland)

About the role

Syneos Health is hiring a CRA II / Senior CRA for a dedicated sponsor pipeline project based in Poland. The role covers on-site and remote monitoring of clinical research studies, quality monitoring and mentoring of junior staff.

Key responsibilities

• Monitor clinical research studies on site and remotely, checking data accuracy and completeness and adherence to study protocols
• Develop tools, procedures and processes for quality monitoring, including standardized monitoring report templates and site visit checklists
• Help design and deliver clinical trial protocols and give input on study design and methodology
• Manage and direct the work of lower-level professionals and oversee day-to-day activities of clinical trial sites
• Document and report clinical trial data accurately and on time, keeping detailed records of site visits and preparing reports for regulatory submissions
• Work with data management, biostatistics and regulatory affairs teams
• Resolve issues related to trial conduct and data integrity, including data collection problems and record discrepancies
• Train and mentor junior staff on monitoring techniques and best practices

Required profile

• Bachelor's degree in a related field
• 3-5 years of experience in clinical research or a related field
• In-depth knowledge of clinical trial processes and regulations
• Preferred: Certified Clinical Research Professional (CCRP) or equivalent certification

Required skills

• Proficiency in clinical trial management systems and software
• Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Strong analytical, problem-solving and communication skills
• Ability to work independently and as part of a team, and to manage multiple projects and priorities