Experience

Advanced Clinical

• United States
• Biotechnology Research
• 700 & Above Employee

• eTMF Associate

  • Mar 2021 - Present



Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. Records Management Associate

  • Jan 2020 - Feb 2021

• Records Management Assistant

  • Aug 2018 - Dec 2019



CIDP - Centre International de Développement Pharmaceutique

• Mauritius
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Project Manager for Photobiology testing

  • Dec 2017 - Mar 2018

  • Management of the clinical trials from day to day.• Preparation/Design of solar studies specific or standard protocols.• Help in preparation/design of CRF, information and consent sheets, subject file, study sheet or any other document required in a study and update of clinical studies TMF.• Report/summary/preliminary results write-up.• AE/SAE reporting to Quality Assurance department and client.• Responsible for archiving of study documents at the end of the study.• Recruitment, training, evaluation and supervision of members of the study team.• Assign study related duties to the study team.• Coordinate the recruitment and follow-up of appointments of the volunteers with the recruitment department within the established deadlines to meet inclusion and non-inclusion criteria and ensure efficient data management.• Managing the general planning for studies.• Managing the costs and budgets of the clinical studies with respect of the study request specifications.• Attend the clients requests and queries.

• Study Manager

  • Jan 2017 - Nov 2017

  • Preparation / design of study protocols, CRF, ICF, ammendments and other study documents;• Create, files and maintain the Clinical Trial Master File (TMF) and Investigator Sites Files to ensure ICH/GCP compliance;• Preparation of studies: progress, preparation of examination room before the start of the studies, equipment verification;• Organizing and overseeing administrative aspects of the studies (necessary consumables and other materials needed, equipment);• Coordinates the staff in effective and efficient use of investigational rooms and safety measures before the start of studies;• Performing evaluation of the subjects eligible to be included in the studies;• Coordinates the study meetings (kick-off, debriefing);• Contribute to qualitative and quantitative evaluation of studies;• Acknowledge of different techniques of evaluation;• Training of the team with regards to all specific techniques and methods of assessment specific to each study;• Ensure proper progress of studies;• Assist and support the investigator throughout the study;• Follow-up of appointments of subjects and follow-up of subjects during studies;• Filling of study documents (CRF and others study documents) and maintain study source • documents;• Data verification of CRF, ICF, source data and/or other documents after filled by subjects;• AE, SAE assessment and reporting to the investigator/Quality assurance/client;• Report/summary/preliminary results write-up;• Archiving of study documents at the end of the study.

• Clinical Trial Coordinator

  • Apr 2015 - Jan 2017

  - Design of study documents (CRF, ICF, and any others study documents);- Filling of study documents;- Follow up of subjects during studies;- Measurements with different equipments;- Products application;- Ensure proper progress of studies;- Summary / Report results write-up;- Filling of documents required to close the TMF (products destruction sheet, archiving, etc) .



OMV

• Austria
• Utilities
• 700 & Above Employee

• Assistant Analyst

  • Oct 2014 - Apr 2015

  • Providing administrative support to Expatriate Services team members; • Managing correspondence internal and external; • Preparing contracts/various amendment letters to be signed; • Booking flights and accommodation for expats and their families; • Initiating the medical process and preparing the medical certificates as part of the immigration process; • Update expatriate database with new employees and their documents; • Expat files review, centralizing information about existing expat documents; • Support for reports centralizing, data verification; • Various allowances calculation.



SC SMS Romania Srl

• Bucharest, Romania

• Sales Assistant

  • Aug 2010 - Sep 2014

  • Cash deposit; • Merchandise reception; • Merchandise processing; • Cash desk duties; • Commercial merchandising; • Customer service; • Evidence and processing of accounting documents (cash book, financial report, NIR). • Cash deposit; • Merchandise reception; • Merchandise processing; • Cash desk duties; • Commercial merchandising; • Customer service; • Evidence and processing of accounting documents (cash book, financial report, NIR).



Fundulea National Research Institute of Agricultural Development, Genetics and Genomics Laboratory

• Bucharest, Romania

• Internship

  • Aug 2011 - Oct 2011

  • DNA isolation from white grain; • Separation and then identification of DNA isolated through agarose gel electrophoresis; • Carrying for PCR reactions. • DNA isolation from white grain; • Separation and then identification of DNA isolated through agarose gel electrophoresis; • Carrying for PCR reactions.