Senior Clinical Research Associate – Oncology, CNS

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

📋 Description

• Oversee site qualification, initiation, interim monitoring, management, and close-out processes.

• Ensure study quality and patient safety by verifying source documents, reviewing informed consent and safety information, checking CRFs, and assisting with data query resolution.

• Foster relationships with investigators and site teams, offering communication, protocol guidance, training, and support throughout the study lifecycle.

• Uphold regulatory, ethics, Investigator Site File, TMF, and investigational product documentation and accountability standards.

• Collaborate with Project Management and study teams to assess deliverables, study milestones, site performance, and monitoring needs.

• Lead CRAs on global studies, including reviewing visit reports and providing mentoring, guidance, and accompanying site visits.

• Create monitoring plans, study-specific tools, templates, and training materials.

• Bring clinical monitoring expertise to study team and investigator meetings, bid defenses, protocols, CRFs, and process initiatives.

• Travel to investigative sites approximately 8–10 days each month.

⛳️ Requirements

• MD or Pharmacy degree with a minimum of 3 years of CRA experience; or a four-year degree in medical, biological, physical, health, pharmacy, or a related science with at least 5 years of CRA experience; or a two-year college curriculum or equivalent education/training, preferably in nursing or life sciences, with at least 7 years of CRA experience.

• Preferred experience in full-service monitoring.

• Strong expertise in clinical research.

• Comprehensive understanding of GCP, ICH Guidelines, FDA and/or EU regulations and directives, local regulatory requirements, and SOPs.

• Required experience in Oncology; CNS experience is a plus.

• Excellent communication, interpersonal, planning, organizational, time-management, initiative, and problem-solving abilities.

• Capability to lead and inspire others when necessary.

• Proficient in Microsoft Office, IxRS, and EDC systems.

• Fluent in Polish and proficient in both spoken and written English.

• Valid current passport and driving license.

• Willingness to travel as needed.

• Must reside in Poland.

🏝️ Benefits

• Collaborative and inclusive work environment.

• Opportunities for growth and career development.

• Chance to learn and expand skills.

• Engaging work that contributes to life-changing therapies.

• Global collaboration and exposure to diverse perspectives.