Sr Clinical Research Associate

University of British Columbia; Hamburg; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

University of British Columbia is seeking a Sr CRA or CRA with startup experience in regulatory and contract negotiations, plus ethics submissions knowledge. The role focuses on monitoring clinical trials and observational studies, ensuring protocol adherence and data integrity.

The candidate will travel up to 50% in Europe, perform site management activities, and support CTMS/eTMF/EDC workflows while coordinating with sponsor teams.

Formación

• Bachelor’s degree in Life Science or equivalent with industry/clinical research experience.
• At least 24 months of clinical research, site management and remote monitoring.
• Prefer 6+ months of on-site monitoring experience.
• Knowledge of medical terminology and regulatory guidelines.
• Strong attention to detail and excellent organizational skills.
• Effective communication skills in English and local language if applicable.
• Excellent critical thinking and problem resolution abilities.
• Proven ability to deliver accurate work on tight timelines.
• Experience with CTMS, eTMF, EDC and Microsoft Office.

Responsabilidades

• Monitor trials remotely and on-site per project timelines.
• Manage site activities and ensure protocol adherence.
• Submit travel and expense reports according to policy.
• Attend project team and manager meetings.
• Prepare site monitoring reports and follow sponsor SOPs.
• Track site issues and close action items per timelines.
• Enter visits and reports in CTMS and ensure data quality.
• Support data reconciliation and EC/IRB communications.
• Maintain study document systems and regulatory files.
• Coordinate travel up to 50% across Europe.
• Support other departments with site management tasks.

Conocimientos

Life Science degree

Clinical research experience

Remote monitoring experience

On-site monitoring experience

Communication skills

Critical thinking

Meeting deadlines in fast pace

English and local language

CTMS experience

eTMF experience

EDC experience

Microsoft Office

Educación

Bachelor’s degree – Life Science

Herramientas

CTMS

eTMF

EDC

Microsoft Office

Descripción del empleo

As a pharmaceutical support industry leader, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBCwe provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.

Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity.

If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

We are looking for a Sr CRA or a CRA with experience working in Start Up; including Regulatory and Contract Negotiations in addition to Ethic Submissions experience.

Brief Description

Monitors clinical trials and observational studies ensuring protocol adherence, managing site activities, and overseeing data collection and integrity. Ensures sites are conducting the study(ies) and reporting study data as required by applicable regulations and guidelines, and sponsor requirements.

Specific Job Duties

• Thorough knowledge and application of project specific protocol
• Performs remote and on-site monitoring in accordance with project specific timelines
• Completes travel scheduling in accordance with project specific and UBC travel policy
• Submits expense reports within UBC requirements
• Attends project team meetings, department meetings and one-to-one meetings with the manager
• Completes site monitoring reports and letters per UBC and/or sponsor SOPs requiring minimal corrections
• Ensures follow-up of site issues and action items per UBC/sponsor timelines
• Enters site visits, site monitoring reports, follow up letter sent date and site contacts into Clinical Trial Management System (CTMS)
• Monitors within Electronic Data Capture (EDC) data entry, if applicable, and assists sites with electronic Case Report Form (eCRF) resolution
• Reviews Investigator Site File and performs Investigational Product reconciliation
• Maintains regular contact with assigned sites per study requirements
• Completes all SOP review, training assessments and documentation within requested timelines
• Travel up to 50% required in the European region
• Completes Site Management and Monitoring activities in accordance with project specific plans and timelines
• Assists with other duties as assigned, which may align with other departments at UBC

The following duties are required for monitoring in the European region:

• Performs review and updates Patient Information Sheet and Informed Consent as per local legislation and requirements.
• Translation from/into local language into/from English for complete study specific communication as needed.
• Preparation, submission and tracking of CTIS, Competent Authority, Central and Local Ethics Committee and other regulatory applications as required.
• Conducts Contract negotiations with Sites, Foundations, and local Research & Development Departments in collaboration with the Contract Management team.
• Reviews and confirms details of payments for sites to be paid as per contract in collaboration with the team
• Maintenance of eTMF and tracks collection of essential documents
• Conducts Study feasibility assessments with sites

Desired Skills And Qualifications

• 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, excellent organizational skills, and the ability to communicate effectively are essential
• Excellent critical thinking and resolution skills
• Proven 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, Microsoft Office applications

UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.