Stefan Karić

Doctor of Medicine
Phone number: +381600826154
Email: karicstefan93@gmail.com
Linkedin: https://www.linkedin.com/in/stefan-karic

WORK EXPERIANCE
➢ Central Monitor (Acting as Central Monitoring Associate) at Syneos Health Feb2022 – Present
Scope: EMEA and US
Overview: Performing Central Monitoring (CM) activities to protect subject safety, data
integrity, and compliance. Acting as Central Monitoring Associate (CMA), responsible for
site managment on 3 studies as primary point of contact for sites.

• CM: Perform remote patient data review activities for Phase I-IV clinical research
and/or noninterventional studies (NIS) to assess compliance with the protocol, ICH-
GCP, and/or all applicable local and federal regulatory requirements.
• CM: Documents observations noted during reviews and issues queries, creates action
items, and records protocol deviations in appropriate systems for action by sites, CRAs
or other functional team members.
• CM: Ensures patient safety and data integrity though the review of patient data
listings, systems, and visualizations via analytical dashboards and/or reports.
• CMA: Primary contact for project site personnel, work in collaboration with the on-site
CRA. Responsible for site management including; performance of remote site
qualification, remote site initiation, remote site monitoring calls (SMCs), and remote
close-out visits ensuring regulatory, ICH-GCP and protocol compliance, and completes
required actions as requested by Clinical Leads and /or Lead CMA.
• CMA: Responsible for ensuring correct IP receipt, handling and storage; knowledge of
protocol, study procedures and adherence to the study CMP; supporting
subject/patient recruitment and retention strategies; collection, ongoing review, and
maintenance of study documents to ensure accuracy, timeliness and completeness of
the TMF; remotely reviews electronic data and assist sites in resolving queries and/or
other identified data issues.
• CMA: Documents monitoring activities via confirmation letters, follow-up letters, and
reports within established timelines. Monitors site performance metrics and, with
guidance, implements action plans for sites not meeting expectations.

➢ Senior Project Admin Specialist at Syneos Health Jul2021 – Jan2022

Overview: Providing support to the Clinical Research Associates (CRA), Clinical Monitoring
Associates (CMA), Clinical Operations Leads (COL) and Project Specialists (PS) to assist with
contracted services.

• Assisting Project Teams in Site Activation (SA) activities, through communication with
sites and collaboration with CRAs. Collecting essential documents, following up with
sites, providing support in acquiring system accesses required for site activation.
Working with Project Managers and global Project Leads to analyze the SA gap.
Reporting findings to upper management.
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 Aug2020 – Jun2021
➢ Project Admin Specialist at Syneos Health
Overview: Providing support to the Clinical Research Associates (CRA), Clinical Monitoring
Associates (CMA), Clinical Operations Leads (COL) and Project Specialists (PS) to assist with
contracted services.

• Performing activities in compliance with applicable Corporate and Clinical Operations

Polices, Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP and ICH
Guidelines.
• Maintenance of Trial Master File (TMF) – Submitting documents to eTMF systems
(Veeva Vault, Trial Interactive) on behalf of CRA, COL, PS and other Project Team
Members. Classification and performing first quality check of document content and
metadata, resolving TMF quality issues.
• Maintenance of TMF milestones – Collaboration with TMF Lead to maintain milestones
completeness, requiredness and expected documents list.
• Performing Activities in Medidata CTMS and Oracle Activate (goBalto) - Supporting
Project Management Team and Clinical Operations through creating sites, site/study
contacts and organizations in CTMS. Supporting Clinical Operations Lead by
maintaining milestones in Oracle Activate (goBalto).
• Transcribing internal, sponsor and other meetings such as CRA/CMA calls into the
meeting highlights. Capturing action items.
• Performing compliance check for site investigators as a part of site selection, essential
documents collection, site maintenance and catalyst documents selection in
accordance with applicable SOPs and WIs.

➢ Medical Doctor – Internship at Clinical Hospital Center Zvezdara Dec2019 – Jun2020

➢ Undergraduate Scientific Researcher at Institute of Rheumatology / Institute of Forensic Dec2016 – Apr2018
Medicine, School of Medicine, University of Belgrade

EDUCATION
Faculty of Medicine, University of Belgrade Sep2012 – Oct2019
• Medical Academic Studies (MD) (GPA 8.5 out of 10)

Medical High School "Dr Andra Jovanovic" Šabac Sep2008 – Jul2012

• Study program: Medical Nurse

LANGUAGE AND COMPUTER SKILLS

• Serbian language - Native Proficiency
• English language - Full Professional Proficiency
• MS office (Word, Excel, PowerPoint) - advanced level
• Medidata RAVE EDC, Veeva Vault, Activate

INTERESTS
• Scientific Research
• Personal Development
• Cycling
• Chess

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