Senior Clinical Research Associate

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

📋 Description

• Oversee clinical trials and observational studies to ensure compliance with protocols, site operations, data collection, and data integrity.

• Conduct both remote and on-site monitoring in accordance with project timelines.

• Arrange travel and submit expense reports following UBC policies.

• Participate in project team, departmental, and managerial meetings.

• Prepare site monitoring reports and follow-up correspondence with minimal revisions required.

• Address site issues and action items within stipulated timelines.

• Log site visits, monitoring reports, follow-up dates, and site contacts into the CTMS.

• Oversee EDC data entry and support sites with eCRF resolution.

• Evaluate Investigator Site Files and reconcile Investigational Product.

• Maintain consistent communication with assigned sites.

• Conduct SOP reviews, training evaluations, and necessary documentation.

• Execute European monitoring activities, which include reviewing patient information and informed consent, managing regulatory submissions, tracking CTIS, submitting to ethics committees, negotiating contracts, confirming payments, maintaining eTMF, tracking essential documents, and assessing study feasibility.

• Undertake Site Management and Monitoring tasks in alignment with project plans and timelines.

• Assist with additional responsibilities as needed.

⛳️ Requirements

• Bachelor’s degree in Life Science preferred or equivalent experience in the industry and clinical research.

• At least 24 months of clinical research experience, specifically in site management and remote monitoring.

• Ideally, a minimum of 6 months of on-site monitoring experience.

• Familiarity with medical terminology and regulatory guidelines, including local legislation.

• Exceptional attention to detail and strong organizational abilities.

• Proficient communication, critical thinking, and problem-solving skills.

• Capability to produce precise work and meet deadlines in a dynamic environment.

• Strong written and verbal communication skills in English and the local language, as relevant.

• Proficient in CTMS, eTMF, EDC, and Microsoft Office applications.

• Willingness and ability to travel up to 50% within the European region.

🏝️ Benefits

• Equal opportunity employer dedicated to fostering a diverse, equitable, and inclusive culture.

• An inclusive workplace that encourages creativity.

• Opportunities for career growth and meaningful impact.