Senior Clinical Research Associate

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

📋 Description

• Independently carry out site monitoring duties for clinical trials.

• Provide oversight, direction, and expertise in the management and execution of clinical trials.

• Ensure compliance with protocols, uphold quality standards, and adhere to SOPs, timelines, and budget constraints.

• Review monitoring visit reports and conduct co-monitoring and evaluation visits.

• Coordinate with cross-functional departments to address clinical trial monitoring challenges.

• Assist in developing study-specific Monitoring Plans and training presentations.

• Set up and gather site-specific ethics documents while supporting site contract negotiations.

• Provide monthly billing details to the finance department.

• Manage study budgets and serve as the sponsor contact for standalone projects.

• Conduct qualification, initiation, interim, and close-out visits both remotely and on-site.

• Prepare accurate and timely reports for monitoring visits.

• Review source documents and ensure the integrity of CRF data.

• Perform quality control and verification of eTMF/TMF documents.

• Conduct accountability for investigational products.

• Review regulatory binders at study sites.

• Maintain communication with study sites regarding protocol/GCP compliance, patient recruitment, and sponsor requests.

• Ensure adherence to ICH GCP guidelines, FDA regulations, and company/sponsor SOPs.

• Participate in internal, client/sponsor, scientific, and other relevant meetings.

• Facilitate adverse event reporting and reconcile SAE reports with source documents and CRFs.

• Resolve discrepancies in data queries with in-house CRAs/CTC and data management teams.

• Identify site challenges and create effective problem-solving strategies.

• Prepare for audits at study sites.

• Support CRA collaboration, new-hire training, onboarding, and mentoring efforts.

• Collaborate on the development and maintenance of Clinical Trial Management Systems.

• Manage competing priorities and fulfill commitments.

• Perform additional assigned responsibilities.

⛳️ Requirements

• A minimum of 4 years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO sectors.

• Capability to independently manage monitoring activities.

• Willingness to travel within Poland.

• Experience in oncology is required.

• Proficient in both Polish and English.

• Quality-focused; meticulous, thorough, and detail-oriented.

• Strong organizational abilities and the capacity to multitask in a dynamic environment.

• Aptitude for managing priorities, organizing time, and solving problems effectively.

• Excellent analytical, negotiation, meeting management, cross-functional teamwork, and leadership skills.

• Ability to travel and handle stress effectively.

• Professional, trustworthy, and disciplined approach to work.

• Capability to tackle unstructured or ambiguous challenges.

• Exceptional communication and interpersonal skills, with a customer service orientation.

• Proficient computer skills, including familiarity with clinical trial management systems, databases, and electronic data capture.

• Knowledge of clinical research, ICH GCP, local regulations, and regulatory and ethical requirements.

• Ability to build and maintain positive relationships with Sponsors, Site, and Project Team members.

• Degree in a scientific health field.

• Proficient in English.

• Bachelor of Science in Biology, Biotechnology, Life Sciences, or Pharmacy.

🏝️ Benefits

• Opportunity for remote work.

• Regular employment contract.