Clinical Research Associate (CRA) Course

• Apr 2022 - Present

Student (German C1 Level)

• Jul 2021 - Dec 2021

Student (Deutsch B2)

• Aug 2020 - Jun 2021

Master Degree Student

• Apr 2018 - Jan 2019

Working on Master Thesis Working on Master Thesis

Immuno-oncology Scientific Advisor, CEE Distributor Market

• Nov 2016 - Dec 2017

-Opinion leaders were identified and credible and lasting professional relationships were established through participation in continuous and balanced scientific exchanges in Bulgaria, Slovakia, Iceland and Malta.-Key information was collected and transferred to the medical affairs department to improve overall medical strategic direction in a timely manner.-Educational medical activities into medical community were executed according to the medical plan (advisory boards, round tables, speaker trainings, and state disease education programs)-Local medical plans by country were developed and executed.-Scientific Advised were provided through clinical education and therapy training to local / regional cross-functional colleagues.

Immunology Scientific Advisor

• Mar 2014 - Mar 2015

-The main KOLs and other stakeholders were identified and engaged establishing strong professional relationships through the exchange of credible and well-balanced scientific information.-The medical scientific action were boosted and appropriate response to unsolicited scientific enquiries or requests were provided in a timely manner.-The local medical plan was developed, managed and executed collaboratively with medical manager within the timeframe.-Field intelligence/competitor information was gathered, filtered and provided to the general manager in order to improve overall strategic direction on a timely basis.-Scientific Advice was given to the local salesforce through specific clinical education and therapy trainings.

Clinical Research Associate (Hematology & Oncology)

• Jun 2013 - Dec 2013

-Potential principal investigators and clinical sites were identified, evaluated and selected for clinical trial execution.-Compliance/quality of clinical trials was implemented and assured according to the SOPs and international regulations.-All clinical trials were supervised from the beginning to the end.-All data sweep and interim analysis were met and ensured for clinical sites prior to closure. -Potential principal investigators and clinical sites were identified, evaluated and selected for clinical trial execution.-Compliance/quality of clinical trials was implemented and assured according to the SOPs and international regulations.-All clinical trials were supervised from the beginning to the end.-All data sweep and interim analysis were met and ensured for clinical sites prior to closure.

Freelance Clinical Research Associate (Ophthalmology & Oncology)

• Jan 2012 - May 2013

-Principal investigators and clinical sites were identified and evaluated based on the provisions of the SOPs.-Pre-study, initiation, monitoring and closure visits were carried out in accordance with SOP/GCP within the timeframe.-eCRF data was verified against source documents, drug accountability and regulatory documents.-Reports of monitoring visits were performed and submitted on time according to the Sponsor's guidelines. -Principal investigators and clinical sites were identified and evaluated based on the provisions of the SOPs.-Pre-study, initiation, monitoring and closure visits were carried out in accordance with SOP/GCP within the timeframe.-eCRF data was verified against source documents, drug accountability and regulatory documents.-Reports of monitoring visits were performed and submitted on time according to the Sponsor's guidelines.

Freelance Clinical Research Associate (Vaccines)

• Sep 2011 - Dec 2011

-Study sites and clinical trial staff were identified and selected according to the Sponsor guidelines and GCPs. -Clinical trials were independently monitored ensuring that they were carried out in accordance with ICH-GCP- Trainings were provided to study site staff and documents related to the clinical trial were managed appropriately.-The quality and integrity of the clinical data were reviewed through in house review of eCRF data and on-site source verification in order to resolve data queries and produce robust data.

Freelance Clinical Research Associate (Vaccines)

• Apr 2010 - Jul 2011

-Qualification, initiation, monitoring, and close out visits were executed in compliance with the approved protocol.-Investigator qualifications, training and resources were verified appropriately, including facilities, laboratories, equipment, and staff.-Medical record and research source documentation against eCRF were verified ensuring good documentation practices and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements.-Investigational product/drug was accounted for according to the Sponsor SOPs.

Freelance Site Start Up Coordinator (SSU)

• Mar 2009 - Mar 2010

-Clinical trial sites were identifying and selected based on the study-defined criteria-Clinical trial sites were activated according to agreed timelines and quality standards.-Site activation activities included: provision of study materials and documents, compilation of documents required for site activation and approval of country/site level informed consents prior to submissions-All regulatory documents were appropriately tracked on CTMS within timeframes.

Teacher - Clinical Biochemistry

• Oct 2008 - Nov 2010

-Responsible for clinically-related undergraduate teaching (lecture/laboratory) in the ClinicalLaboratory Program at the University.-An independent and collaborative research program was developed with departments that were related to Clinical Biochemistry. -Students were trained in clinical Biochemistry and coordinated clinical internship experience was supervised according to the University guidelines.-Academic advising of students was performed in order to execute the undergraduate thesis.