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.
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We are looking for a Sr CRA or a CRA with experience working in Oncology, Start Up including Regulatory and Contract Negotiations in addition to Ethic Submission experience
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.
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 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
- Travel up to 50% required in the European region
- 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
The following duties are required for monitoring in the European region:
- Performs review and updates Patient Information Sheet and Informed Consent as per local legislation and requirements.
- Translation from/into local language into/from English for complete study specific communication as needed.
- Preparation, submission and tracking of CTIS, Competent Authority, Central and Local Ethics Committee and other regulatory applications as required.
- Conducts Contract negotiations with Sites, Foundations, and local Research & Development Departments in collaboration with the Contract Management team.
- Reviews and confirms details of payments for sites to be paid as per contract in collaboration with the team
- Maintenance of eTMF and tracks collection of essential documents
- Conducts Study feasibility assessments with sites
Desired Skills and Qualifications:
- Bachelor’s degree – Life Science preferred or equivalent years of industry and clinical research experience
- Minimum of 24 months’ clinical research experience, specifically in site management and remote monitoring
- Preferably at least 6 months’ on-site monitoring experience
- Knowledge of medical terminology and regulatory guidelines, including local legislation
- Strong attention to detail, excellent organizational skills, and the ability to communicate effectively are essential
- Excellent critical thinking and resolution skills
- Proven ability to deliver accurate work and adhere to deadlines in a fast-paced environment
- Good written and verbal communication skills in English and local language (as applicable)
- Experience and familiarity with CTMS, eTMF, EDC, Microsoft Office applications
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.
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