Job Title: YLM02H - Senior Clinical Research Associate (SCRA)
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. Mentors and trains junior level CRAs.
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 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
Supervisory Responsibility: None
Desired Skills and 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:
At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally.
Here are some of the exciting perks UBC offers:
- 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
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