Clinical Study Assistant

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

📋 Description

• Provide assistance for essential daily clinical study operations, ensuring regulatory inspection readiness in line with established protocols.

• Work in partnership with Clinical Operations/Study Manager, study teams, and CROs to facilitate clinical study activities.

• Execute departmental responsibilities as required.

• Review study documentation, which includes essential document packets, study plans, and informed consent forms.

• Support and supervise risk-based monitoring initiatives.

• Participate in important team meetings and document minutes for selected studies.

• Aid in regulatory inspection readiness, which includes compiling SOP lists and storyboards.

• Assist with clinical trial systems such as CTMS/TMF and related activities.

• Provide support for vendor contract management.

• Help with study close-out procedures, including financial reconciliation.

• Engage in additional ad-hoc tasks as agreed upon with management.

• Collaborate with Legal, Insurance, R&D departments, CROs, and external vendors.

⛳️ Requirements

• A Bachelor's degree in a scientific or healthcare-related field, or an equivalent international degree, is required.

• 1-2 years of experience in the pharmaceutical industry or clinical research organization as a CTA or Study Coordinator.

• Experience with Phase 2 and 3 studies, as well as global/international studies, is a plus.

• Proficiency in the Veeva system is a must.

• Experience working across various therapeutic areas, including oncology, is beneficial.

• Knowledge of global/regional regulatory and compliance standards for clinical research.

• Proven excellence in task management and cross-functional teamwork.

• Strong communication skills.

• Exceptional teamwork, organizational, interpersonal, and problem-solving abilities.

• Proficient in business English (both oral and written).

• Capability to work collaboratively in a fast-paced environment with a keen attention to detail.

• Willingness to travel as necessary (approximately 10%).

• Legal authorization to work in Poland.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.