Sr Clinical Research Associate

University of British Columbia; Deutschland; On-site; EUR 60,000 - 90,000; Full time

Job summary

University of British Columbia is seeking a Sr Clinical Research Associate to oversee monitoring of clinical trials in the Berlin area. The role focuses on protocol adherence, data integrity, and coordinating with sites to ensure regulatory compliance and timely study progression.

Responsibilities include on-site and remote monitoring, vendor and contract coordination, and ensuring accurate documentation in CTMS/eTMF systems. Strong communication and regulatory knowledge are essential to succeed.

Qualifications

• Bachelor's degree in Life Science or equivalent is required.
• Minimum 24 months of clinical research experience in site management and remote monitoring.
• On-site monitoring experience is preferred.
• Strong knowledge of regulatory guidelines and local legislation.
• Excellent written and verbal communication in English and local language where applicable.
• Experience with CTMS, eTMF, EDC and MS Office is expected.

Responsibilities

• Monitors clinical trials and observational studies ensuring protocol adherence.
• Manages site activities and ensures timely data collection and integrity.
• Performs remote and on-site monitoring per project timelines.
• Handles contract negotiations and regulatory submissions in collaboration with teams.
• Maintains CTMS data entry and site visit documentation; prepares monitoring reports.
• Travel up to 50% in Europe as needed and complies with travel policies.

Skills

Clinical research

Site management

Regulatory knowledge

Communication skills

Analytical thinking

Problem solving

Education

Bachelor's degree – Life Science or equivalent

Tools

CTMS

eTMF

EDC

Microsoft Office

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Sr Clinical Research Associate

Regular Research & Clinical Berlin, DL

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 UBC we 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.