Sr Clinical Research Associate - Oncology

United Biosource Corporation•All Virtual Locations, Home Based Position, USA, Remote, US,

5d•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 of Respect, Accountability, Innovation, Quality, Integrity, and Collaboration. 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

US-based Sr. CRA with 5 years of monitoring experience.
Minimum of 3 years of oncology monitoring experience.
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 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.

Nice To Haves

Experience working in clinical trials and observational studies preferred.

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.
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.
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.