Sr Clinical Research Associate

United Biosource Corporation• Remote, US,

7d•Remote

About The Position

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 being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. 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!

Requirements

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

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