Note: The job is a remote job and is open to candidates in USA. UBC is a pharmaceutical support industry leader devoted to empowering health solutions for a better tomorrow. The Senior Clinical Research Associate will monitor clinical trials, ensuring protocol adherence and managing site activities while mentoring junior CRAs.
Responsibilities
- 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
- 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
Skills
- Bachelor's degree
- 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)
- Proven ability to deliver highly accurate work and adhere to deadlines in a fast-paced environment
- Life Science preferred or equivalent years of industry and clinical research experience
- Experience working in clinical trials and observational studies preferred
- Experience and familiarity with CTMS, eTMF, EDC, Microsoft Office applications
Benefits
- Remote opportunities
- 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
Company Overview
Company H1B Sponsorship