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Senior Principle Clinical Research Associate
Job
Talecris Biotherapeutics
US
-
RTP,
North Carolina
Job Code - 4168
Position - Full - Time Regular
Job First Active on: Tuesday, October 27, 2009
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JOB DESCRIPTION: Senior Principle Clinical Research Associate
Manage study process to ensure adherence to protocol, SOPs, GCP/ICH Guidelines, applicable regulatory requirements, and other documentation requirements, including:
• Ensures site compliance with the study protocol, data quality, and regulatory requirements
• Assist with expedited identification, retrieval and review of study documents particularly those required for site activation/study start-up
• Initiate and maintain expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up
• Assist the Study Manager in coordinating and leading the activities of the Clinical Research Associate team to meet the overall study objectives
• Co-monitor with CRO and internal Clinical Research Associate staff to insure study integrity and compliance
• May conduct Pre-Study Visits, Site Initiation Visits, Interim Monitoring, and Close-Out Visits at assigned sites
• Collaborate with internal functional areas to manage study issues and support milestone achievement
• Develop ICF templates and review study specific ICF(s)
• Assist in development of study operation manual and monitoring plans
• Participate in CRF development and completion guidelines
• Review monitoring reports and QA reports from site visits
• Assist in establishing appropriate clinical tools and processes for the study team
• Assist in managing clinical study set-up, follow-up study activities through ongoing tracking and review
• Coordinate clinical issue escalation and resolution.
• Review templates and plans developed by CRO
• Assist in the development of study timelines and ensure compliance with study timelines
• Coordinate and present at investigator meetings
• Ability to objectively identify and effectively document site findings with an equal ability to re-educate, place corrective action in place with the site, and follow-up as required
• Assist with effective and timely audit responses
Communicate and interact with project team including:
• Effectively convey project information to study teams and sites
• Effectively, independently, and accurately answer team and site questions in a timely manner while using discernment on to escalate to Study Manager
• Develop collaborative relationships with internal and external teams
• Identify quality issues with the study through regular review of team communications and implement appropriate corrective actions plans
• Monitor vendors and other service providers for quality of service
• Prepare key reports and documents on progress of study for Study Manager
• Effective in investigative site training and re-education
Oversight of study documents, including:
• Review and track regulatory documents
• Site regulatory and tracking documents
• Project Status Reports
• Project Core Documents
Assist Study Manager:
• Verify and monitor adherence to the regulatory document collection process
• Interact as functional lead with data management, safety, regulatory personnel, and other functional groups, as appropriate
• Review data listings, participate in query process, and liaise with data management to ensure completion of all activities in preparation for database lock
• Vendor selection process and ongoing vendor management (including CRO, Central Laboratory, IVRS, etc.)
• Maintain study timelines
REQUIREMENTS - QUALIFICATIONS: Senior Principle Clinical Research Associate
• Associate’s required or Bachelor’s preferred
• 5-7 years of experience in clinical research
• Minimum of 3 years field monitoring experience and 2 years in lead Clinical Research Associate role
• Thorough knowledge of and demonstrated competency in medical terminology and clinical trial process
• Thorough knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Demonstrated interpersonal skills to ensure positive team and vendor relationships
• Demonstrated ability to develop tools and processes that increase measured efficiencies of a project
• Demonstrated ability to work independently in performing responsibilities
• Demonstrated ability to lead a team
• Demonstrated computer proficiency in MS Office Suite and Impact (within 60 days if new hire)
Talecris Biotherapeutics
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