Alexandra Marinescu
Bucharest
Overview
7
7
years of professional experience
Work History
Clinical Research Associate I
Fortrea
05.2023 - Current
- Perform on-site monitoring and site management of Phase II-IV clinical research studies, conducting all types of monitoring visits in Romania and United Kingdom.
- Maintain effective communication with sites, establishing solid relationships with Investigators and all other site staff.
- Assure compliance with local regulations, International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs.
- Critically evaluating adequacy of Investigator sites (qualifications, facilities, equipment and performance).
- Complete and submit monitoring reports in accordance with SOP/Work Instructions or Sponsor requirements as agreed in scope of work.
- Maintain awareness of key study performance indicators for own sites.
- Update study and patient status information.
- Document and track resolution of all outstanding site-specific protocol-related, quality or ICH/GCP compliance issues from contact to contact.
- Ensure sites have required study training and are compliant with protocols, regulatory guidelines and study procedures.
- Review of electronic data completed by sites and assist sites in resolving queries and other identified data issues.
- Ensure electronic Trial Master File is current and up to date.
- Seek guidance to resolve complex issues.
Associate CRA
IQVIA
06.2022 - 04.2023
- Perform site monitoring visits (initiation, routine and close out visits) as blinded CRA, but also as unblinded CRA, in accordance with contracted scope of work and good clinical practices.
- Evaluate the quality and integrity of study site practices related to proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF), and data query generation and resolution.
- Collaborate and liaise with study team members for project execution support as appropriate.
Senior Clinical Trial Administrator
PSI CRO
10.2021 - 05.2022
- Assistance in preparation and follow-up of TMF audits.
- Preparation and review of Essential Documents Pack (EDP), item required for site activation.
- Support of CA and EC submissions and notifications.
- Preparation and update of Investigator Site File (ISF) and ISF checklists.
- Financial and contractual documentation processing.
- Quality check of various documents and reports.
- Preparing and providing training to new employees in different topics as required.
- Organization of internal meetings and preparation of agendas and meeting minutes.
Clinical Trial Administrator
PSI CRO
06.2019 - 09.2021
- Preparation and processing of essential clinical trial documents.
- Exchange of data, documents and other project relevant information between investigative sites, site vendors, project team and other departments.
- Assistance in the tracking and distribution of safety reports.
- Support of CA and EC submissions and notifications.
- Maintenance of eTMF.
- Assistance with handling financial and contractual tasks.
- Providing miscellaneous project support.
Pharmacist
Help Net Pharma
01.2017 - 05.2019
- Preparing and supervising magistral and officinal formulas.
- Advise patients on recommended dosage, warnings, storage, and possible side effects of all dispensed medication.
- Develop strong relationships with healthcare providers to optimize patient care and medication adherence.
- Patient counseling regarding proper intake of medications.
- Manage drug and supply inventories.
- Monitor ordering of pharmacy medication stock to maintain streamlined inventory and low overhead.
Education
Residency Program in Clinical Pharmacy
Bucharest Emergency University Hospital
Bucharest, RomaniaOncology Boot Camp Course
Fortrea
Bucharest, Romania02.2024
Residency Program in General Pharmacy
“Carol Davila” University of Medicine And Pharmacy
Bucharest, Romania01.2023
Fundamental GCP Training Course
IQVIA CRO
07.2022
CRA School
EMEA FSP CRA School IQVIA CRO
06.2022
BPharm - Pharmacy
"Carol Davila" University of Medicine And Pharmacy
Bucharest, Romania09.2016
Skills
- Action planning
- Data Analysis
- Organizational Skills
- Attention to Detail
- Analytical Thinking
- Team Training
Skills
Clinical research, Critical Thinking, Oral communication, Excellent interpersonal skills, Customer service experience, Administrative support, Database, drug development, GCP, Management skills, Meetings, Monitoring, Organizational skills, Presentations, Regulatory documents, EDC, SOP
Timeline
Clinical Research Associate I
Fortrea
05.2023 - Current
Associate CRA
IQVIA
06.2022 - 04.2023
Senior Clinical Trial Administrator
PSI CRO
10.2021 - 05.2022
Clinical Trial Administrator
PSI CRO
06.2019 - 09.2021
Pharmacist
Help Net Pharma
01.2017 - 05.2019
Residency Program in Clinical Pharmacy
Bucharest Emergency University Hospital
Oncology Boot Camp Course
Fortrea
Residency Program in General Pharmacy
“Carol Davila” University of Medicine And Pharmacy
Fundamental GCP Training Course
IQVIA CRO
CRA School
EMEA FSP CRA School IQVIA CRO
BPharm - Pharmacy
"Carol Davila" University of Medicine And Pharmacy
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