Marketing, Behavioral Psychology, Body Language, Phytopreparations, natural healing, homeopathy, Neurological and neurodegenerative disorders, Biotechnology and modern medicine therapy
Katarina Nedić
In-House Clinical Research Associate II
Summary
Licensed Pharmacist and In-House Clinical Research Associate II with over 8 years of experience across community pharmacy, clinical operations, and clinical trial management within a global CRO. Strong expertise in TMF oversight, Veeva Vault system, GCP compliance, site management, remote monitoring, EDC review, and cross-functional collaboration. Proven ability to support end-to-end clinical trial operations while applying pharmacy and medication knowledge, seeking a pharmaceutical industry role aligned with clinical development, clinical operations, or medical affairs
Overview
8
8
years of professional experience
7
7
Certifications
5
5
Languages
Work History
In-House Clinical Research Associate II
Worldwide Clinical Trials
04.2025 - Current
- Supported clinical trial start-up and site management activities, including feasibility assessments, confidentiality agreements, site documentation, and coordination of study materials and investigational product (IP) logistics.
- Conducted remote, interim, initiation, and close-out monitoring activities in compliance with ICH-GCP, GDP, and company SOPs, providing operational support to Field CRAs and Clinical Trial Managers.
- Managed Trial Master File (TMF) and Investigator Site File (ISF) documentation, ensuring quality, completeness, and inspection readiness through TMF reconciliation and quality control checks.
- Performed remote data review of EDC systems, supported resolution of data management and vendor queries, tracked subject eligibility and recruitment activities, and generated study reports and trackers for project teams and sponsors.
- Served as the primary operational contact for study sites, maintaining regular communication, supporting site staff training and access, mentoring junior In-house CRAs, and presenting trial updates during study meetings.
In-House Clinical Research Associate I
Worldwide Clinical Trials
05.2023 - 04.2025
- Supported site feasibility, start-up, and study conduct in compliance with ICH-GCP, including CDA collection, site onboarding, regulatory document collection, and Subject Eligibility Review tracking.
- Maintained TMF and ISF integrity by reviewing essential documents for completeness, accuracy, and GDP/GCP compliance, supporting TMF reconciliation and TMF QC activities.
- Performed remote monitoring and oversight under CRA/CTM guidance, including EDC CRF review, data quality checks, query resolution, protocol deviation tracking, and visit preparation across study phases.
- Coordinated regulatory and operational site activities, including IP accountability support, study material shipment/receipt, CTMS updates, vendor access management, and maintenance of inspection-ready trackers and reports.
- Acted as primary regulatory point of contact for sites, ensuring ongoing compliance with Monitoring and Site Management Plans, managing site staff changes and training documentation, mentoring In-house CRAs, and presenting compliance updates during study meetings.
Clinical Operations Assistant
Worldwide Clinical Trials
01.2022 - 05.2023
- Managed and quality-controlled Trial Master File (TMF) documentation for multiple pharmaceutical clinical studies, ensuring compliance with ICH-GCP, regulatory authority requirements, sponsor SOPs, and inspection-readiness standards
- Supported CRA and Site Management teams by resolving TMF QC queries, liaising with study sites for outstanding documents, and processing essential documents in eTMF systems
- Performed ongoing TMF Quality Control in compliance with ICH-GCP, regulatory requirements, sponsor guidelines, and industry best practices
- Supported study close-out and regulatory submission readiness by collecting, reconciling, and finalizing essential documents for sponsor delivery and long-term archival
- Provided operational and regulatory support including remote CRF review, query resolution via EDC systems, investigational product accountability documentation, and administrative support aligned with pharmaceutical quality systems
TMF Operation Associate
Worldwide Clinical Trials
05.2021 - 01.2022
- Acted as TMF Approver and TMF QC Reviewer in accordance with SOPs and pharmaceutical GxP quality systems, ensuring Trial Master File completeness, traceability, and continuous inspection readiness
- Reviewed, classified, and managed Essential Documents within eTMF and Electronic Document Management Systems, maintaining audit trails, version control, and document integrity compliant with regulatory expectations
- Planned, prepared, and executed risk-based and periodic TMF Quality Control reviews, generating QC checklists and metrics aligned with ICH-GCP, health authority regulations, sponsor requirements, and industry best practices
- Proactively identified, documented, and escalated TMF quality and compliance risks to project and quality teams, supporting timely corrective actions and minimizing inspection findings
- Partnered with cross-functional project teams to support health authority inspections and sponsor audits, including preparation, reconciliation, and secure transmission of TMF and critical regulatory documents
Community Pharmacist
Benu Pharmacy chain
12.2017 - 05.2021
- Retail Pharmacy SC Ušće and Pharmacy Airport City, Belgrade
- Deputy manager at Airport City pharmacy
- Provided safe, patient-focused pharmaceutical care including prescription verification, clinical checks, counseling, and medication therapy support in compliance with legal, regulatory, and professional standards
- Supported pharmacy operations as Deputy Manager, overseeing daily workflow, staff supervision, training, and ensuring adherence to SOPs, quality standards, and regulatory inspections
- Managed inventory, controlled drugs, and reimbursement processes while contributing to service development, patient safety initiatives, and continuous quality improvement
Education
Master of Pharmacy - Master of pharmacy
Faculty of Pharmacy, University of Belgrade
01.2016
Grammar school - undefined
Dusan Vasiljev Kikinda
01.2011
Skills
MS Office package
Site management
Detailed documentation
ICH guidelines
Organizational skills
Attention to detail
Quality control
Clinical research coordination
Drug accountability
Clinical trial management
Source document verification
Good clinical practice
Study monitoring
Regulatory compliance
Certification
’’Fast Reading’’ course, Leonida Institute, based on Tony Buzan 2020
Interests
SCIENTIFIC PAPERS
- ’’Examination of the quality and antimicrobial activity of cultivated marigold, Calendula officinalis L. ’’, made at the Department of Pharmacognosy and Immunology and microbiology at the Faculty of Pharmacy in Belgrade (2015-2016)
The paper was:
- presented at 57. Congress of Biomedical Sciences at the Silver Lake in April 2016 and 3rd international congress of students of biomedical sciences (GSC) in Belgrade in October 2016
- Published in the 67th edition of the magazine ’Medicinski podmladak’
PERSONAL CHARACTERISTICS AND OTHER ABILITIES
- Creative, competent and communicative, experienced in team and individual work as well as designing creative content. Work with the elderly and children, psychological approach, skills of understanding and reacting in accordance with the situation and personal profile. Coordination and management of people, projects, organizational skills, meeting management skills, negotiations.
- Driving license category B
- Travel fan
Timeline
In-House Clinical Research Associate II
Worldwide Clinical Trials
04.2025 - Current
In-House Clinical Research Associate I
Worldwide Clinical Trials
05.2023 - 04.2025
Clinical Operations Assistant
Worldwide Clinical Trials
01.2022 - 05.2023
TMF Operation Associate
Worldwide Clinical Trials
05.2021 - 01.2022
Pharmacy license in Serbia
02-2018
Community Pharmacist
Benu Pharmacy chain
12.2017 - 05.2021
Grammar school - undefined
Dusan Vasiljev Kikinda
Master of Pharmacy - Master of pharmacy
Faculty of Pharmacy, University of Belgrade