Lead Clinical Research Associate
United BioSource Corporation - Kansas City, MO

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Want to be part of a growing organization? Want to make a difference in your career? Then UBC is the place for you!

United BioSource Corporation (UBC) is a fast-growing, full-service global pharmaceutical services organization. At UBC, we seek only the brightest, most talented professionals in the industry to help us grow further. If you are looking for a new challenge, UBC fosters personal and professional growth on diverse and challenging projects amid highly respected scientific, clinical and technical professionals.
Specific Job Duties:
• Thorough knowledge of sponsor specific project requirements, protocol and timelines
• Reviews and approves Site Visit Reports and Letters within UBC and/or Sponsor timelines
• Maintains at least one active site per study assignment
• Assists with project specific training
• Ensures appropriate CRA visit scheduling per protocol; tracks, reports and escalates (as needed) adherence to site visit schedule, trip report metrics and CTMS entry of completed tasks
• Maintains Q&A log for site and monitoring issues
• Maintains and tracks Issues & Actions Log to assure timely resolution per UBC and/or Sponsor timelines
• Serves as primary liaison for clinical monitoring issues, escalating as appropriate to Project Manager and/or Functional Manager
• Attends client and project team meetings – assists with preparation, content and leading of meetings as required
• Assists with reporting on monitoring activity to include status report, co-monitoring and trip report metrics
• Acts as back-up for Project Manager and may be primary contact for UBC/Sponsor interaction
• Coordinates EDC data entry, if applicable, and DCF resolution
• Coordinates site assignments in conjunction with Project Manager and Functional Manager; assists with other project specific tasks as delegated by Project Manager
• Consistently completes on site monitoring in accordance with project specific timelines
• Consistently completes travel scheduling in accordance with project specific and UBC guidelines
• Attends project team meetings, departmental meetings and 1:1 with manager a minimum of monthly; responsible for content discussed during these meetings
• 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 with minimal corrections required
• Enters site visits, confirmation/follow-up letters and site monitoring reports into CTMS
• Consistently completes Call Log or Telephone Contact Report detailing communication with sites in a timely manner
• Completes Regulatory Binder and Investigational Product reconciliation
• Maintains regular contact with assigned sites per protocol
• Consistently completes expense reports within UBC timelines and 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 by being an AIM leader
o A = Assess visit type, assess protocol specific and UBC SOP knowledge and assess individual’s ability to perform visit type independently
o I = Instruct how to conduct visit, report/letter writing and manage issues and actions
o M = Mentor team member by sharing tips/tricks/tools reviewing process prior to and after visit
• Assists management team by mentoring other CRAs
• Assists with preparation and/or delivery of presentations for UBC Academy, departmental training and/or sponsor specific training
• Creates and maintains clinical project documents with Project Manager oversight and finalizes with appropriate team review (PM, Sponsor, etc.)
o Includes: Clinical Management Plan, Trip Report and Letter Templates, CRF Transmittal Form, Monitoring Worksheet, input for Monitoring Plan
• Bachelor’s degree – Life Science preferred or equivalent industry and monitoring experience
• Minimum of more than 24 months active monitoring
• Knowledge of medical terminology
• Good written and verbal communication skills
• Displays leadership, organizational and interpersonal 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
• Proven skills with CTMS, EDC, Outlook, Excel and other basic computer software and client specific systems (if applicable)
• Thorough knowledge of ICH, GCP, CFR and UBC SOPs
• Up to 50% travel
We are an Equal Opportunity Employer, M/F/D/V

United BioSource Corporation - 19 months ago - save job - copy to clipboard
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