Rūta Avėnienė
Lithuania
Summary
Dynamic and detail-oriented Clinical Research Associate with a robust pharmaceutical background and extensive experience in clinical trial monitoring and site management. Committed to upholding protocol compliance, ensuring data integrity, and delivering high-quality study conduct in alignment with GCP and regulatory standards. Proven ability to cultivate strong relationships with investigators and site staff, facilitating successful study outcomes across various therapeutic areas, including cardiology, gastroenterology, and dermatology. Since entering the field in June 2019 as a Regulatory and Start-up Specialist in the EMEA region, developed a comprehensive understanding of local regulatory requirements and gained valuable hands-on experience through interim monitoring visits, site selection, site initiation and site close-out activities.
Overview
17
17
years of professional experience
1
1
Certification
Work History
CRA 2
IQVIA RDS
04.2022 - Current
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- 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.
- Collaborate and liaise with study team members for project execution support as appropriate.
CRA 1
IQVIA RDS
09.2020 - 03.2022
Regulatory and Start-Up Specialist 1
IQVIA RDS
06.2019 - 08.2020
- Serve as a Single Point of Contact in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management. Ensure adherence to Standard Operating Procedures, Work Instructions, quality of designated deliverables and to project timelines. Perform Regulatory, Start-Up and Maintenance activities according to applicable regulations, SOPs and Work instructions.
- Distribute completed documents to sites and internal project team members.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Review, prepare and negotiate site contracts and budgets with sites.
- Ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized and specific projects deliverables are completed.
- Participate in feasibility and/or site identification activities.
Pharmacist at Outpatient dispensary in Rotherham Hospital
Lloyds Pharmacy
04.2012 - 12.2018
- Properly filled and dispensed an average of 300 items on outpatient prescriptions per day.
- Responsible for daily safe and accurate medicines dispensing.
- Managed drug and supply inventories.
- Made sure all General Pharmaceutical Council requirements were met.
- Worked alongside colleagues and doctors.
- Counseled patients on their new medication.
- Gave advice to customers on over-the counter medication.
Relief Pharmacist
Lloyds Pharmacy
03.2010 - 03.2012
- Properly filled and dispensed an average of 400 items on the prescriptions per day.
- Gave advice to patients on over-the counter medication.
- Performed Medicines Use Review service to customers.
- Performed New Medicine Service to customers.
- Responsible for daily safe and accurate medicines dispensing.
Pharmacist
Benu Pharmacy
09.2008 - 01.2010
- Managed drug and supply inventories.
- Responsible for daily safe and accurate medicines dispensing.
- Gave advice to patients on their medication.
Education
Master of Pharmacy - Pharmacy
Lithuanian University of Health Sciences
06.2009
Skills
- Friendly, positive attitude
- Teamwork and collaboration
- Customer service
- Problem-solving
- Attention to detail
- Organizational skills
- Critical thinking
- Dependable and responsible
Certification
- Fundamental GCP Accreditation Exam, 2020
- Fundamental GCP Accreditation Exam, 2019
- GCP Certification Exam, 2022
Language(s)
Lithuanian: Fluent in Speaking, Reading, Writing
English: C1 in Speaking, Reading, Writing
Russian: Basic in Speaking, Reading, Writing
Timeline
CRA 2
IQVIA RDS
04.2022 - Current
CRA 1
IQVIA RDS
09.2020 - 03.2022
Regulatory and Start-Up Specialist 1
IQVIA RDS
06.2019 - 08.2020
Pharmacist at Outpatient dispensary in Rotherham Hospital
Lloyds Pharmacy
04.2012 - 12.2018
Relief Pharmacist
Lloyds Pharmacy
03.2010 - 03.2012
Pharmacist
Benu Pharmacy
09.2008 - 01.2010
Master of Pharmacy - Pharmacy
Lithuanian University of Health Sciences