Laxmi Priya Kolguri
Clinical Trial Coordination Assistant at CORRIB Research Centre for Advanced Imaging and Core Laboratory- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
Topline Score
Bio
Experience
-
CORRIB Research Centre for Advanced Imaging and Core Laboratory
-
Ireland
-
Medical Practices
-
1 - 100 Employee
-
Clinical Trial Coordination Assistant
-
Aug 2023 - Present
Support and assist the roles within the coordination unit in coordination level operational activities required during set up, execution and close out phase of studies coordinated by the coordination team. • Support and assist the Trial coordinators in the development of training materials for training key study and site personnel. • Support and assist the Trial coordinators and data mangers in the development of CRFs, the eCRF and the DMP during study set up. • Support the Trial coordinators and Data managers to raise and progress eCRF query resolution as part of site management and data management activities in addition to any other applicable data oversight and data cleaning activities requiring support. • Support the Trial coordinators and vigilance officers in the processing of safety events and associated reporting as part of safety management activities. • Support TMF and eTMF reconciliation and Trial Management System set-up and associated TMF management activities. • Support the preparation of in house site files and TMF binders etc and the coordination of Investigator payments and any other trial related payments. • Support the Receipt, processing and tracking of image/trial related materials (e.g ECG’s, Angiograms and other event materials for CORRIB imaging core lab) for clinical trials coordinated within the applicable unit’s coordination team. • Assist the team in the set up and scheduling of training as appropriate on study-related activities and processes for site personnel and assist with the preparation of training materials. • Assist the team with the preparation of updates for sponsor, Chief Investigator, data and safety monitoring committees, regulatory bodies, ethics committees, and other governing bodies on the status of all clinical trial activities, as required. • Conduct clinical research work to a high standard in accordance with applicable clinical research regulations and protocols under the direction of the units’ leadership team. Show less
-
-
-
Syneos Health
-
United States
-
Biotechnology Research
-
700 & Above Employee
-
TMF Document Specialist
-
Apr 2021 - Dec 2022
Support the set-up, maintenance and closure of TMF repositories. Perform quality review of documents submitted for entry into the TMF. Participates in preparation/reconciliation of TMF documents. Performs all work duties assigned for the completeness. Support the set-up, maintenance and closure of TMF repositories. Perform quality review of documents submitted for entry into the TMF. Participates in preparation/reconciliation of TMF documents. Performs all work duties assigned for the completeness.
-
-
-
IQVIA
-
United States
-
Hospitals and Health Care
-
700 & Above Employee
-
Clinical process coordinator
-
Apr 2019 - Feb 2020
Associated in supporting centralized monitories activities as CPC. Associated in Infosario QC. Maintained study timelines and ensure accurancy in reporting of project status. Associated in supporting centralized monitories activities as CPC. Associated in Infosario QC. Maintained study timelines and ensure accurancy in reporting of project status.
-
-
Education
-
JNTUH College of Engineering Hyderabad
Bachelor's degree, Pharmacy -
Sri chaitanya junior college
Board of intermediate education, science