About the role
As a pharmaceutical support industry leader, UBCis devoted toempowering health solutions for a better tomorrow. We takeprideinimprovingpatient outcomes andadvancing 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 rewardingcareer journey with UBC! Growyour career while making a meaningfulimpacton theworldaround you.UBCfosters a culture built on our Core Values of Respect, Accountability, Innovation, Quality, Integrity, and Collaboration. We believe in aninclusive workplacethat fosters creativity.
If you are seeking a career that willchallenge, inspire,andrewardyou, join us atUBC!
We are seeking a US-based Sr. CRA with 5 years of monitoring experience, including at least 3 years in oncology and some ophthalmology monitoring.
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
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.
Originally posted on Himalayas