Bosilka Kocare
Clinical Research Associate
Vienna
Summary
Driven Clinical Research Professional with over 11 years of extensive experience in clinical trials and regulatory affairs. Possessing certifications in Good Clinical Practice and Advanced GCP, with a track record of achieving zero compliance issues during audits and enhancing trial timelines by 15%. Proven ability to mentor teams and foster strong relationships with investigator sites, ensuring efficient trial execution. Eager to leverage unique expertise in delivering successful clinical trials for organisations focused on innovative healthcare solutions.
Overview
16
16
years of professional experience
5
5
Languages
Work History
Senior Clinical Research Associate
Precision for Medicine
06.2025 - Current
- Managed data entry and database maintenance, guaranteeing accuracy and security of participant information.
- Coordinated sample retrieval and processing, documenting data in alignment with laboratory protocols.
- Set up, cleaned and maintained laboratory equipment for optimal use and accurate results.
- Monitored data to verify accurate file documentation and storage in accordance with regulatory requirements.
- Managed patient follow-up, maintaining engagement and adherence to study protocols for robust outcomes.
- Prepared samples accurately for different testing techniques.
Senior Clinical Research Associate II
Parexel
09.2022 - Current
- Championed protocol compliance, resulting in zero compliance issues during audits.
- Executed meticulous reviews of study documents including informed consent forms, source documentation, case report forms, and regulatory documents, demonstrating an exceptional eye for detail.
- Fostered trust and collaboration by cultivating robust relationships with investigator sites to ensure seamless trial execution.
- Collaborated closely with cross-functional teams to overhaul trial processes, achieving a 15% reduction in timelines.
- Earned certification in Good Clinical Practice (GCP) and Advanced GCP training.
- Identified and mitigated risks associated with clinical trials through proactive assessments.
- Mentored and trained a team of 9 junior CRAs, which led to a 40% improvement in trial execution timelines.
Clinical Research Associate II
LabCorp
07.2021 - 09.2022
- Conducted site initiation, interim monitoring, and close-out visits to ensure strict adherence to protocol compliance, data integrity, and patient safety.
- Delivered comprehensive training and support to investigative sites to enhance operational efficiency.
- Implemented risk-based monitoring strategies, successfully identifying and mitigating potential risks to data quality and patient safety.
Senior Specialist Regulatory Affairs
PharmaLex Bulgaria JSC
01.2020 - 07.2021
- Provided comprehensive global regulatory support for a diverse portfolio of products.
- Managed the lifecycle of regulatory dossiers for the Bayer Consumer Health project, ensuring compliance with evolving regulations.
- Spearheaded launch planning and portfolio management by conducting insightful regulatory analyses for product registration.
Regulatory Affairs Manager
Septima DOOEL
01.2019 - 01.2020
- Organised the regulatory sector, successfully obtaining and maintaining over 200 Marketing Authorisations for pharmaceutical companies.
- Acted as the primary communication liaison with health authorities and pharmaceutical companies, facilitating effective dialogue.
Clinical Research Associate
Talisker Project Management
01.2017 - 01.2019
- Negotiated financial compensation agreements with physicians for projects in development, ensuring fair and equitable terms.
- Conducted onsite audits to ensure strict adherence to protocols, contributing to quality assurance.
Qualified Person Responsible for Pharmacovigilance
Septima DOOEL
01.2012 - 01.2017
- Processed global adverse events while maintaining an accurate local database.
- Prepared and submitted aggregate safety reports to health authorities, ensuring compliance with regulations.
Medical Representative
Septima DOOEL
01.2010 - 01.2012
- Promoted OTC and medicinal products to healthcare professionals through strategic initiatives.
- Created promotional materials and delivered impactful presentations to enhance brand awareness.
Education
Master of Science - Clinical Studies
Medical University of Vienna
09.2025
Master Degree - Pharmaceutical EU Regulation
Skopje University 'SS. Cyril and Methodius'
01.2020
Master - Pharmacy, Faculty of Pharmacy
Skopje University 'SS. Cyril and Methodius'
06.2010
Skills
GCP guidelines
Timeline
Senior Clinical Research Associate
Precision for Medicine
06.2025 - Current
Senior Clinical Research Associate II
Parexel
09.2022 - Current
Clinical Research Associate II
LabCorp
07.2021 - 09.2022
Senior Specialist Regulatory Affairs
PharmaLex Bulgaria JSC
01.2020 - 07.2021
Regulatory Affairs Manager
Septima DOOEL
01.2019 - 01.2020
Clinical Research Associate
Talisker Project Management
01.2017 - 01.2019
Qualified Person Responsible for Pharmacovigilance
Septima DOOEL
01.2012 - 01.2017
Medical Representative
Septima DOOEL
01.2010 - 01.2012
Master Degree - Pharmaceutical EU Regulation
Skopje University 'SS. Cyril and Methodius'
Master - Pharmacy, Faculty of Pharmacy
Skopje University 'SS. Cyril and Methodius'
Master of Science - Clinical Studies
Medical University of Vienna