Lead Clinical Research Associate
hace 5 meses
UBC are currently recruiting within our clinical leadership team, we are looking to recruit a Lead CRA within the EU.
UBC are a leading provider of pharmaceutical support services, partnering with life science companies to demonstrate value, ensure safe use and accelerate patient access to innovative medical products. Our services range from supporting the largest brands in the industry, to providing fully outsourced functional services, to the most recently approved genetic therapies in orphan populations. The work we do positively impacts patients’ lives all over the world.
**Brief Description**:
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
- 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.
- 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 logístical 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 Mo
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