Sr Clinical Research Associate - Oncology

About the role

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 of Respect, Accountability, Innovation, Quality, Integrity, and Collaboration. 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!

Responsibilities

• 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 UBC's 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
• Assists Project Manager (PM) and management team by mentoring, training and assessing junior CRAs
• Assists with preparation and/or delivery of presentations for UBC CRA training, departmental training and/or sponsor specific training
• Assists PM and/or Lead CRA with additional tasks as needed
• Travel up to 80% required in the North American 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

Qualifications

• Bachelor's degree - Life Science preferred or equivalent years of industry and clinical research experience
• Minimum of 36 months on-site monitoring experience including site selection, initiation, management, and monitoring activities
• Comprehensive knowledge of medical terminology and regulatory guidelines
• Excellent critical thinking and resolution skills
• Excellent written and verbal communication skills in English and local language (as applicable)
• Experience working in clinical trials and observational studies preferred
• Experience and familiarity with CTMS, eTMF, EDC, Microsoft Office applications
• Proven ability to deliver highly accurate work and adhere to deadlines in a fast-paced environment

Benefits

• Remote opportunities
• Competitive salaries
• Growth opportunities for promotion
• 401K with company match*
• Tuition reimbursement
• Flexible work environment
• Discretionary PTO (Paid Time Off)
• Paid Holidays
• Employee assistance programs
• Medical, Dental, and vision coverage
• HSA/FSA
• Telemedicine (Virtual doctor appointments)
• Wellness program
• Adoption assistance
• Short term disability
• Long term disability
• Life insurance
• Discount programs