Natia Sharvashidze
Overview
13
13
years of professional experience
Work History
Senior Clinical Research Associate
Freelancer
10.2021 - Current
- Responsible for recruitment of potential investigators, involvement in RA and EC submissions and notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
- Responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study initiation visits, regular visits and close out visits, assist on audit/inspection visits and assists in site and vendor contracting process, liaison with vendors and other duties
- Functions as the primary contact for sites regarding regulatory compliance and protocol questions and communicates with clinical sites on an ongoing basis to address and resolve issues
- Assists in Business Development activities
- May have supervisory functions in clinical projects
- May be required to train, coach and supervise junior staff
- Performs tasks according to relevant SOPs and completes the SOPs training in given timelines.
Senior Clinical Research Associate
TRIO (Translation Research in Oncology)
08.2019 - 10.2021
- Review and approve remote and on-site monitoring visits, including site selection, initiation, close-out visits
- Follow up with sites on issues between monitoring visits
- Ensure issues are reported on time in the Clinical Trial management System and are adequately followed until closure
- Support CRAS and sites in all kinds of cases during the course of the trial
- Oversee activities with Third Party Organization (TPOs), to have detailed information on the activities they perform, organize regular calls with TPOs to follow up on items
- Organize the submission of Ethics Committee and Ministry of Health: translate and prepare submission package, the adaptation of documents (e.g ICF, patient diaries) based on local requirements
- Participate in the development/review of the trial operational documents and global communications to site/CRAS
- Prepare and/or review training material for the CRAS on the trial/global calls with all CRAS and performs presentations
- Perform Quality Controls on the country/site files and work with the Administrative Project Coordinator(s) until resolution of any issues
- Negotiate amendments to financial agreements with investigators/sites as per trial requirements
- Review and approve invoices, support finance with site fee reconciliation
- Reply to findings of audits and act as an audit coordinator with other TRIO departments
- Participate in the revision of procedures within the PM department.
Senior Clinical Research Associate
LLC Arensia Exploratory Medicine
03.2014 - 08.2019
- Responsible for recruitment of potential investigators, involvement in RA and EC submissions and notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
- Responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study initiation visits, regular visits and close out visits, assist on audit/inspection visits and assists in site and vendor contracting process, liaison with vendors and other duties
- Functions as the primary contact for sites regarding regulatory compliance and protocol questions and communicates with clinical sites on an ongoing basis to address and resolve issues
- Assists in Business Development activities
- May have supervisory functions in clinical projects
- May be required to train, coach and supervise junior staff
- Performs tasks according to relevant SOPs and completes the SOPs training in given timelines.
Project Manager/ Regulatory Manager
LLC Arensia Exploratory Medicine
01.2012 - 01.2015
- Project oversight; Delegation of study duties within the study personnel; Main point of contact for all involved parties, vendors Sponsor and/or managing CRO; Responsible for project conduct with highest standards, quality and in accordance with the agreed timelines and budget
- Collecting and submitting regulatory documentation to the regulatory authority within timelines
- Responsible for the preparation and coordination of submissions to regulatory, ethics and other bodies
- Responsible for the timely follow-up for queries made by EC/CA
- Responsible for the collection of critical documents required for IP Release
- Develop and maintain effective relationships with local, regional and country authorities
- Comply with all departments' requirements regarding information provision and status updating and reporting
- Travel domestic and/or international
- Anticipated activities may include attendance at Bid Defenses, Kick-Off, Investigator or study team meetings.
Timeline
Senior Clinical Research Associate
Freelancer
10.2021 - Current
Senior Clinical Research Associate
TRIO (Translation Research in Oncology)
08.2019 - 10.2021
Senior Clinical Research Associate
LLC Arensia Exploratory Medicine
03.2014 - 08.2019
Project Manager/ Regulatory Manager
LLC Arensia Exploratory Medicine
01.2012 - 01.2015
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