Sr Clinical Research Associate

Brief Description

Maintains protocol adherence, manages site activities, oversees data collection and integrity, 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
• SUBMIT 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/SPOONER 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
• MANTAINS 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 ASSESSES JUNIOR CRAS
• AUXILIES IN PREPARATION AND/OR DELIVERY OF PRESENTATIONS FOR UBC CRA TRAINING, DEPARTMENTAL TRAINING AND/OR SPONSOR SPECIFIC TRAINING
• AUXILIES PM AND/OR LEAD CRA WITH ADDITIONAL TASKS AS NEEDED
• TRAVEL UP TO 80% REQUIRED IN THE NORTH AMERICAN REGION
• MONITORS WITHIN SITE MANAGEMENT AND MONITORING ACTIVITIES IN ACCORDANCE WITH PROJECT SPECIFIC PLANS AND TIMELINES
• AUXILIES WITH OTHER DUTIES AS ASSIGNED, WHICH MAY ALIGN WITH OTHER DEPARTMENTS AT UBC

Supervisory Responsibility

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

• Remote opportunities
• Competitive salaries
• Growth opportunities for promotion
• 401K with company match
• Tuition reimbursement
• Flexible work environment
• Discretionary PTO (Paid Time Off)
• Paid holidays
• 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 Information

UBC is committed to an inclusive workplace that fosters respect for each other, our clients, and our patients. UBC is 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.