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Clinical Research Associate
Responsible for site management from initiation to close-out.
Build relationships with client, investigators, and site staff.
Participate in Investigator and other external or internal meetings as required.
Perform on-site visits in accordance with the monitoring plan.
Conduct on-site study-specific training.
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 Study Team (i.e. non-responsive site, Protocol Deviations concerns, quality issues etc., items that require face to face interaction).
Collect Statutory Regulatory Package 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 systems on an ongoing basis.
Collaborate with Study Team 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.
Attend audits / Regulatory Inspection if requested.
Proven track record of site monitoring, with strong regulatory knowledge including GCP.
Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word.
Excellent interpersonal, verbal and written communication skills.
Sound problem solving skills.
Ability to successfully work in a “virtual” team environment.
Sound presentation skills.
Client focused approach to work with the ability to interact professionally within a client organization.
Ability to prioritise multiple tasks and achieve project timelines.
Shows commitment to and performs consistently high quality work.
Effective time management in order to meet daily metrics or team objectives.
Able to take initiative and work independently.
Sense of urgency in completing assigned tasks.
Able to travel a minimum of 65% on average and holds a driving license and passport.
Educated to Degree level (biological science, pharmacy or other health-related discipline preferred), equivalent nursing qualification or other equivalent experience.
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