Clinical Research Associate II

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Job Description :
Key Accountabilities
• Assume the ability to meet the requirements of a CRA I with a high degree of proficiency and autonomy
• Take responsibility for specific tasks on projects, or acts as the main CRA contact on individual projects
• Train team members on selected tasks
• Keep manager informed about work progress and any issues to avoid surprises. Requires some interaction/supervision by Manager or assigned mentor
• Build relationships with investigators and site staff
• Participate in Investigator and other external or internal meetings as required
• Arrange on-site visits and logistics (e.g. travel arrangements)
• Perform on site visits in accordance with the monitoring plan
• Conduct on-site study-specific training (if applicable)
• Perform site facilities inspection
• Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations
• Monitor and maintain ICH-GCP compliance
• Responsible for the completeness and quality of the on-site files
• Respond to site issue alerted from Clinical Monitoring Associate (i.e, non-responsive site,
• Protocol Deviations concerns, quality issues etc., items that require face to face interaction)
• Collect SRP documents during QV and other visits as needed
• Establish site recruitment plan in collaboration with site during Qualification Visit; follow-up and update at Initiation Visit and Monitoring Visit
• Update all relevant tracking system on an ongoing basis
• Collaborate with CMA on site issues/actions
• Generate visit/contact report in accordance with monitoring plan
• Code and scan Central File documents where applicable
• Ship relevant wet-ink signature documents to the Assistant or back to the site
• Escalate any issues that require immediate action to the CRA Coordinator/GRO Lead
• Attend audits / Regulatory Inspection if requested



Qualifications :
Skills
• Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word
• Strong regulatory knowledge including GCP
• Excellent interpersonal, verbal and written communication skills
• Sound problem solving skills
• Ability to successfully work in a (‘virtual’) team environment
• Sound presentation skills
• Consultative skills
• Client focused approach to work, ability to interact professionally within a client organization
• Ability to prioritize multiple tasks and achieve project timelines
• Able to take initiative and work independently.
• Sense of urgency in completing assigned tasks
• Able to travel a minimum of 65% on average
• Holds a driving license where required
• Effective time management in order to meet daily metrics or team objectives
• Shows commitment to and performs consistently high quality work

Education
• Educated to degree level (biological science, pharmacy or other health-related discipline
• preferred), equivalent nursing qualification or other equivalent experience

Language Skills
• Competent in written and oral English


Minimum Work Experience
• Substantial monitoring experience in clinical research


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