Company: Docs Global (Continental Europe)
Reference: Ref AS-019929
Closing Date: 24 Jan 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
DOCS has partnered with a highly prestigious organisation with one of the most robust pipeline within the industry. We have a great job opportunity for a Lead CRA with CRA oversight experience who are ready to further develop their career.
Roles & Responsibilities of the position
The Regional Clinical Lead (RCL) is responsible for the performance of investigator sites and supporting the field based Clinical Research Associates (CRAs) in accordance with the Monitoring Plan, Study Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations. The RCL acts as a primary liaison between CRAs/investigational sites and the Clinical Trial Manager (CTM). The RCL will be responsible for effective management of relationships and communication with external team/vendors including investigators and Clinical Research Organizations (CROs), and other external partners as applicable.
The responsibilities include but are not limited to:
• Oversight of site activities in accordance with the Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations
• Implementation of enrollment and recruitment strategies
• Attend monitoring visits with CRAs to assist with site management, quality oversight, and site relationship enhancement
• Identify sites with potential risks and co-monitor as needed to evaluate, address concerns, document activity, follow site for resolution
• Management of site and monitoring performance metrics
• Protocol deviation tracking, trending and assessment of preventative action effectiveness, and assessment of risks through Key Risk Indicators (KRIs)
• Review CRA trip reports and action items, document assessment of monitor and site quality/performance based upon report, follow site/monitor for issue resolution, escalate when needed
• Issue escalation, root cause analysis and determination of corrective/preventative actions
• Perform remote monitoring of clinical database
• Develop training materials and study tools for sites and CRAs use
• Attend study team calls and meetings
• Support other objectives for the clinical operations department
• Requires 60% travel
• BS/BA degree or equivalent
• 5+ years of on-site monitoring and management performing pre-study visits, initiation, interim and close out visits
• Minimum of 3 years of recent Oncology Experience
• Lead CRA / Oversight Experience
• Experience mentoring CRAs/Junior CRAs preferred
• Experience with Risk Based Monitoring
• Experience with EDC systems
• Working knowledge of FDA regulations and ICH/GCP guidelines
• Proven ability to demonstrate strong decision making and problem solving skills
Competitive salary, medical insurance, annual holiday and other benefits.
Please contact Dariusz Sternlicht, Recruitment Consultant at DOCS on +48 606 130 397 or email your up-to-date CV to: firstname.lastname@example.org
DOCS provides global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical trial industry.
Clinical Research Associate, Lead, CRA manager, Site Oversight, CRA Oversight, Co-Monitoring, Pharmaceutical, CRO, Pharma, Contract Research Organisation, Biotech, Medical Device, Health, Biotechnology, Chemistry, Contract, Warsaw, Poland
2 Globeside, Globeside Business Park
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