Senior Clinical Research Associate

UBC

. Monitor clinical trials and observational studies for protocol adherence .

Posted 10/14/2026full-timeRemote • GermanySeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial monitoring, site management, and regulatory compliance, with strong skills in data integrity and project management. Proficient in communication and critical thinking, ensuring adherence to protocols and timelines.

Highest-signal resume keywords

Clinical Research ExperienceSite ManagementRemote MonitoringCTMS ProficiencyRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial MonitoringData CollectionProtocol AdherenceMedical TerminologyRegulatory GuidelinesSite Monitoring ReportsECRF ResolutionSOP ReviewsStudy Feasibility AssessmentsContract Negotiations

Soft Skills

Attention to DetailOrganizational SkillsEffective CommunicationCritical ThinkingResolution Skills

Tools & Technologies

CTMSETMFEDCMicrosoft Office

Industry Keywords

Clinical TrialsObservational StudiesInformed ConsentPatient Information SheetsLocal Legislation

About the role

Key responsibilities & impact

Monitor clinical trials and observational studies for protocol adherence
Manage site activities and oversee data collection and integrity
Ensure sites conduct studies and report data according to regulations, guidelines, and sponsor requirements
Apply project-specific protocols
Perform remote and on-site monitoring according to project timelines
Schedule travel according to project and UBC travel policies
Submit expense reports within UBC requirements
Attend project, department, and one-to-one manager meetings
Complete site monitoring reports and letters with minimal corrections
Follow up on site issues and action items within required timelines
Enter site visits, monitoring reports, follow-up letter dates, and site contacts into CTMS
Monitor EDC data entry and assist with eCRF resolution
Review Investigator Site Files and reconcile Investigational Product
Maintain regular contact with assigned sites
Complete SOP reviews, training assessments, and documentation
Perform Site Management and Monitoring activities according to project plans and timelines
Review and update Patient Information Sheets and Informed Consent documents according to local requirements
Translate study communications between English and the local language as needed
Prepare, submit, and track CTIS, Competent Authority, and Ethics Committee regulatory applications
Conduct contract negotiations with sites, foundations, and local Research & Development departments
Review and confirm site payment details
Maintain eTMF and track essential documents
Conduct study feasibility assessments with sites
Perform other assigned duties that may align with other UBC departments

Requirements

What you’ll need

Bachelor’s degree – Life Science preferred or equivalent years of industry and clinical research experience
Minimum of 24 months’ clinical research experience, specifically in site management and remote monitoring
Preferably at least 6 months’ on-site monitoring experience
Knowledge of medical terminology and regulatory guidelines, including local legislation
Strong attention to detail and excellent organizational skills
Ability to communicate effectively
Excellent critical thinking and resolution skills
Ability to deliver accurate work and adhere to deadlines in a fast-paced environment
Good written and verbal communication skills in English and local language, as applicable
Experience and familiarity with CTMS, eTMF, EDC, and Microsoft Office applications
Willingness and ability to travel up to 50% in the European region

Benefits

Comp & perks

Equal opportunity employer
Diverse, equitable and inclusive workplace culture
Career growth and meaningful impact opportunities