Senior Clinical Research Associate
- Experience Level
- Experienced (non-manager)
This position is available office based in London or home based in the UK
Brief Description: Monitors in accordance with ICH, GCP, CFR guidelines, UBC and project SOPs
- Bachelor’s degree – Life Science preferred or equivalent years of industry and monitoring experience
- Minimum of > 24 months active monitoring
- Thorough knowledge of medical terminology
- Good written and verbal communication skills
- Consistently meets or exceeds metrics for quality trip reports and letters
- Consistently meets or exceeds metrics for completion of UBC and/or sponsor training with appropriate documentation
- Ability to perform tasks in CTMS, EDC, Outlook and client specific systems (if applicable)
- Thorough knowledge of ICH, GCP, and UBC SOPs
- Up to 20% travel
Supervisory Responsibilities: Mentoring new and/or junior CRAs/CSS
Specific Job Duties:
- Thorough knowledge and application of project specific protocol
- Thorough knowledge of the local country laws applicable to clinical trials/ observational studies and ICH GCP.
- Consistently completes on site monitoring visits (including pre-study, initiation, interim monitoring and close-out visits ) in accordance with project specific timelines
- Complete remote monitoring activities in accordance with project specific timelines
- Consistently completes travel scheduling in accordance with project specific and UBC guidelines
- Attends project team meetings, department meetings as required.
- Consistently completes site monitoring reports, confirmation/follow-up letters per UBC and/or client SOPs; signs, scans and/or provides to CSS/RDS for filing in Trial Master File according to UBC and/or sponsor timelines requiring minimal corrections
- Ensures follow-up of site issues and action items per UBC/sponsor timelines
- Enters site visits, confirmation/follow-up letters and site monitoring reports into CTMS
- Ensures completion of Call Log or Telephone Contact Report detailing communication with sites per protocol
- Monitors within EDC data entry, if applicable, and assists sites with DCF resolution
- Completes Regulatory Binder
- Consistently submits expense reports within UBC timelines; consistently follows UBC Travel Guidelines
- Consistently completes SOP review and documentation within requested timelines
- Consistently completes sponsor specific training and documentation within requested timelines
- Assists PM and management team with co-monitoring.
- Assists management team by mentoring other CRAs
- Assists with preparation and/or delivery of presentations for UBC Academy, departmentaltraining and/or sponsor specific training
- Input into production of local language version of Patient Information Sheet and Informed Consent
- Review of translations
- Translation from/into local language into/from English for complete study specific communication
- Review and input into study protocol and case report form (CRF) review
- Preparation, submission and tracking of local ethics committee and other regulatory applications
- Contract negotiation with hospitals and local R&D Departments
- Data Management Department data query resolution
- Check of EDC tools and if required translation into local language
- Administrative and logistical support to the Project Manager of (international) clinical trials in order to coordinate all study-related activities.
- Maintain TMF, track collection of essential documents
- Organize logistics of international study meeting
- Translation of all types of Clinical Trial related documents from/into local language into/from English
- Study feasibility assessments
- Complete UBC Track according to project specific requirements
- Complete all other project specific tracking tools
- Escalate issues found at the site in timely manner according to project specific requirements
United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.
While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.
Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
You can find out more by visiting