Senior Clinical Research Associate

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

📋 Description

• Oversee clinical trials and observational studies to ensure adherence to protocols.

• Coordinate site activities and supervise data collection and its integrity.

• Confirm that sites execute studies and report data in compliance with regulations, guidelines, and sponsor requirements.

• Implement project-specific protocols effectively.

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

• Arrange travel in accordance with project and UBC travel policies.

• Submit expense reports following UBC guidelines.

• Participate in project, departmental, and individual meetings with managers.

• Complete site monitoring reports and correspondence with minimal revisions.

• Address site issues and action items within designated timelines.

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

• Supervise EDC data entry and facilitate eCRF resolution.

• Review Investigator Site Files and reconcile Investigational Product records.

• Maintain consistent communication with assigned sites.

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

• Execute Site Management and Monitoring tasks as per project plans and timelines.

• Review and update Patient Information Sheets and Informed Consent documents per local regulations.

• Translate study communications between English and the local language as required.

• Prepare, submit, and monitor CTIS, Competent Authority, and Ethics Committee regulatory applications.

• Negotiate contracts with sites, foundations, and local Research & Development departments.

• Review and verify site payment details.

• Maintain the eTMF and track essential documents.

• Conduct feasibility assessments for studies with sites.

• Perform additional duties as assigned that may correspond with other UBC departments.

⛳️ 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, particularly 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 capabilities.

• Ability to communicate effectively.

• Strong analytical thinking and problem-solving skills.

• Capacity to produce precise work and meet deadlines in a fast-paced setting.

• Proficient written and verbal communication skills in English and the local language, as applicable.

• Experience with CTMS, eTMF, EDC, and Microsoft Office applications.

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

🏝️ Benefits

• Equal opportunity employer.

• A diverse, equitable, and inclusive workplace culture.

• Opportunities for career advancement and meaningful impact.