Experience

Antaros Medical

• Sweden
• Biotechnology Research
• 1 - 100 Employee

• Clinical Trial Coordinator

  • Feb 2022 - Present



Heart Care Clinical Research LLP, INDIA

• Junior Manager-Clinical Research Operations

  • Nov 2018 - Sep 2020

  Responsible for assistance in national and international research projects at site including communication with stakeholders. Involved in business development activities, feasibility and budget discussion.Undertaken the financial responsibility like prepared invoices, payment reconciliation of trial and site level expenses.Provided training on protocols, SOPs, ICH GCP guidelines and applicable guidelines. Given presentations on protocols in Ethics committee meetings and presented trial data at investigator meetings. Assisted investigators to compose research papers. Responsible to ensure that studies are conducted in compliance with protocol, SOPs, ICH-GCP guidelines and applicable guidelines.Maintained the trial Master file as well as site master file including site SOPs revision and Instrument calibrations on timely basis. Assisted during audits and inspections at site followed by CAPA submission. I resigned from my position due to migration and I entered in Sweden in October 2020.

• Senior Clinical Research Coordinator

  • Dec 2015 - Oct 2018

  Mainly involved in coordination for ongoing and upcoming clinical trials accordance with applicable guidelines and Site SOPs.Worked with investigators for recruitment and retention of trial subjects which include screening, enrolment and follow up coordination.Responsible for data collection, maintenance of source documents, CRF entries, data clarification and query resolution.Maintained Investigational product includes tracking, storage condition, drug accountability (subject specific and site specific) and reconciliation. Assisted in site selection, site initiation and close-out. Prepared site for audit and inspection along with routine monitoring visit. I was promoted in same company with additional responsibilities as a Junior manager_ clinical research operations.



Lifecare Institute of Medical Science and Research, INDIA

• Clinical research Coordinator

  • Oct 2010 - Sep 2013

  Performed trial subject’s visits by Coordinating with different departments such as pathology, radiology, nursing staff, etc. Involved in dispense of investigational product through IVRS or IWRS. Done Documentation of source notes and transcription of the data on CRFs (Paper & e-CRFs). Reported the AE, SAE, End points to regulatory body, Sponsor, CRO and IRB/IEC within timeline. Assisted during monitoring visit and responded to Queries and monitoring Action items. Performed trial subject’s visits by Coordinating with different departments such as pathology, radiology, nursing staff, etc. Involved in dispense of investigational product through IVRS or IWRS. Done Documentation of source notes and transcription of the data on CRFs (Paper & e-CRFs). Reported the AE, SAE, End points to regulatory body, Sponsor, CRO and IRB/IEC within timeline. Assisted during monitoring visit and responded to Queries and monitoring Action items.