Senior Clinical Research Associate

This is a fully remote position, open to applicants in Poland.

📋 Description

• Act as the primary point of contact and site manager during all stages of clinical research studies.

• Take full accountability for assigned sites and cultivate robust relationships with site personnel.

• Execute clinical study site management and monitoring tasks while adhering to ICH-GCP, Sponsor SOPs, local laws and regulations, protocols, and monitoring plans.

• Acquire a comprehensive understanding of study protocols and associated procedures.

• Coordinate activities to achieve Site Ready status and provide insights on site selection and validation.

• Conduct both remote and on-site monitoring and oversight.

• Perform validation, initiation, monitoring, and close-out visits at sites.

• Document visit and non-visit contact reports accurately and in a timely manner.

• Gather, review, and oversee regulatory documentation for study initiation, ongoing management, and closure.

• Liaise with investigators and site staff concerning protocol execution, recruitment, retention, deviations, documentation, audits, inspections, and site performance.

• Identify, evaluate, and address site performance, quality, and compliance issues.

• Collaborate with the Clinical Research Manager and Partner Line Manager to escalate issues as needed.

• Manage information and documentation within the Clinical Trial Management System, electronic Trial Master File, and other relevant systems.

• Share expertise as a process subject matter expert, buddy, or mentor.

• Assist or lead audit and inspection activities and conduct co-monitoring visits.

• Complete necessary training, submit timesheets and expense reports, update CV, and adhere to Parexel and client processes and applicable regulations.

⛳️ Requirements

• Proven expertise in site management, including overseeing site performance and patient recruitment.

• A demonstrated high level of monitoring proficiency with sound independent judgment.

• Ability to interpret and analyze data and metrics, and respond appropriately.

• Solution-focused mindset towards complex challenges, utilizing root cause analysis and implementing preventive and corrective measures.

• Strong time management, organizational, interpersonal, conflict resolution, and problem-solving abilities.

• Excellent verbal and written communication skills, with the capability to comprehend and convey technical information effectively.

• Proficiency in working effectively within a matrix, multicultural environment and fostering culturally sensitive working relationships.

• Customer-oriented approach, with a focus on quality and compliance.

• Positive, growth-oriented mindset and self-motivated attitude, with the capacity to work independently.

• High accountability and urgency, with the ability to prioritize and manage multiple tasks concurrently.

• Competent IT skills, including proficiency in MS Office and clinical IT applications on computers, tablets, and mobile devices.

• Fluent in both the local language and English, in verbal and written forms.

• Solid understanding and practical knowledge of clinical research, clinical trial phases, current GCP/ICH standards, and country-specific clinical research laws and guidelines.

• Familiarity with global and country/regional clinical research regulations.

• Hands-on experience with Good Documentation Practices.

• Minimum of 2 years of direct site monitoring experience in bio/pharma/CRO.

• Possession of a current driver's license.

• Willingness to travel domestically and internationally approximately 65%-75% of the working time, about 2-3 days per week.

• Bachelor's degree in a science-related field (Biotechnology, Pharma, Biology) is preferred.

🏝️ Benefits

• Competitive salary.

• Attractive benefits package.

• Company car or car allowance.

• Comprehensive medical care plan: Health, Dental & Vision.

• Life Assurance coverage.

• Exceptional work environment.

• Culture that promotes teamwork and collaboration.

• Supportive colleagues who face challenges together.

• Access to innovative technology.

• Extensive training opportunities.

• Paid time off.

• Life insurance coverage.

• Health insurance benefits.

• Additional benefits in accordance with the terms of applicable plans.

• Potential eligibility for extra incentives, bonuses, or other compensation programs.