Lead Clinical Research Associate

Working alongside the Project Management Team, oversees performance of assigned Clinical Research Associates (CRAs)/ Clinical Site Specialists (CSSs) and site activities in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines, Clinical Trial directives, European Regulations , Local Legislations, GDPR and UBC and/ or Sponsor SOPs.

LCRAs work with a qualified Study Team of Clinical Research Associates who identify, select, initiate, monitor and close-out investigational sites and with the CSS who provide project support for clinical studies in phases I – IV, ensuring adherence to applicable regulations.   

Requirements:

• A Bachelor's degree in a health care or other scientific discipline or educational equivalent is preferred, or equivalent working experience
• Seeking candidates with 5+ years of site management required with preference of 2 years field monitoring experience
• Knowledge and understanding of the European and local country laws applicable to clinical trials and observational studies
• The LCRA acts as a primary liaison between the CRAs and the Clinical Project Management team
• Thorough knowledge of clinical and medical terminology
• May perform oversight on all CRA tasks not limited to but including -on-site monitoring performance as well as remote monitoring of CRAs as applicable. 
• Excellent written and verbal communication skills in English and local language.
• Interpersonal, leadership, organizational, communication and effective time management skills.
• Ability to work independently and within a cross-functional team environment.
• Be confident in taking responsibility for operational day-to-day project oversight
• Ability to coordinate monitoring project activities at local, national, and international studies
• Required to meet or exceed metrics for completion of UBC and/or Sponsor training with appropriate documentation.
• Being open to work with upcoming changes in this environment
• High attention to detail
• Computer skills including CTMS, eTMF, EDC, Microsoft Office (Outlook, Excel, PowerPoint, Word), Time tracking and Expense management systems, online training systems, HR systems, electronic communication tools and other required computer software and client specific systems / tools. 
• Due to the nature of this position travel may be required

Supervisory Responsibilities: 

None; but assists with training of CRAs/SCRAs/CSSs and mentoring of new and/or junior CRAs, CSSs, Vendor CRAs, as applicable to the project.

Specific Job Duties:

• Thorough knowledge of Sponsor specific project requirements and processes, study protocol, and timelines
• Oversee the day-to-day clinical site operations of European and/or multi-national global projects
• Oversee all aspects of clinical site operations conduct from start-up through close-out
• Serves as primary liaison for clinical monitoring issues, escalating as appropriate to Project Manager and/or Functional Manager
• Collaborate with PM to provide input into clinical site management resourcing, analyzing cost variances, out-of-scope management, and conducting revenue recognition as applicable
• Monitor project progress against the established plans and ensure compliance with plans
• Provide clinical input and participate in the design and review of study protocols, case report forms (CRFs), study reports, and other functional documents and plans in collaboration with project team
• Assists Project Manager with the creation and maintenance of project specific documents (i.e., study plans, Patient Information Sheet, Informed Consent (PIS-ICF), where required.
• Coordinate development of patient/subject consent forms and site/patient materials
• Ensure Trial Master File (TMF/eTMF) is maintained and audit-ready on ongoing basis
• Monitor and ensure project team compliance with maintenance of Clinical Trial Management System (CTMS) 
• Attends client and project team meetings – assists with preparation, content and leading of meetings as required
• Leads and reports on regular calls with CRA team for project oversight.
• Serves as primary liaison for clinical monitoring issues, escalating as appropriate to Project Manager and/or Functional Manager
• Provides administrative and logistical support to the Project Manager of clinical trials to coordinate all study-related activities
• Assists with other project specific tasks as delegated by Project Manager.
• May assist as back-up for Project Manager when feasible, being the primary contact for UBC/ Sponsor interaction
• Reviews and approves Site Monitoring Visit/Remote Monitoring Call Reports and Follow-up Letters in compliance with UBC and/or Sponsor timelines
• Identifies and escalates site/monitoring related issues to the functional/ project management team in a timely fashion, as applicable
• Required to meet or exceed metrics for quality monitoring visit reports and letters review.
• Lead or assist with project specific trainings 
• Maintains oversight and compliance of the CTMS, including but not limited to monitoring visit scheduling, contact log entry, site and monitoring performance metrics, issue escalation and corrective actions
• Consistently reviews completeness and maintenance of CTMS, according to project specific requirements
• Ensures maintenance and tracking of Protocol Deviations, Issues & Actions Log to assure timely resolution per UBC and/or Sponsor timelines
• Assists with reporting on monitoring activity to include status report (visits performed, protocol deviations, patient screening and enrolment, withdrawals, SAEs), assessments and trip report metrics.
• Coordinates EDC data entry and DCF resolution, if applicable
• Consistently completes travel scheduling and expense report completion in accordance with project specific and UBC guidelines, where applicable
• Ensures that Site Visits, Confirmation/ Follow-up Letters and Site Monitoring Reports are tracked into CTMS per UBC/ Sponsor timelines
• Ensures CRAs/ CSSs, as required, are filing all required documents in the eTMF.
• Ensures maintenance of eTMF, ISF and other project files, following the ALCOA criteria (attributable, legible, contemporaneous, original, and accurate).
• Consistently completes UBC and/or Sponsor trainings and documentation within requested timelines.
• May assist management team with Assessment Visit oversight of CRAs/ other Clinical Operations team members as required
• Assists management team with mentoring of other LCRAs/ CRAs and CSSs if needed.
• Assists with development and/or delivery of training materials and study tools for site and CRA use.
• Assists the Management team by leading Internal Team Meetings, sponsor local Calls and /or other project calls, as required
• Reviews translations (if applicable), according to UBC/Sponsor SOPs
• Reviews the preparation, submission and tracking of Competent Authority, Central and Local Ethics Committee (as needed) and other regulatory applications
• Reviews and keeps oversight of contract negotiation activities with the Sites, and local Research & Development (R&D) Departments
• May assist with oversight and review of filing and tracking of project invoicing, when applicable
• May assist with reviews of study feasibility assessments status and oversight.
• Consistently completes and maintains all other project specific tracking tools related to this role
• Maintains oversight to ensure CRAs are compliant with all other project specific tracking tools, as required by project. 
• May assists Project Manager and Functional Manager responsible for Vendor CRA management with organization, escalation and management of compliance, performance, and quality issues (particularly affecting, but not limited to, Vendor CRAs)
• Other tasks as requested

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