Summary
Overview
Work history
Education
Skills
Languages
Accomplishments
Certification
Affiliations
Timeline
Generic
Inna Ivolina

Inna Ivolina

St. Petersburg,Russia

Summary

Graduated from St. Petersburg State Chemical-Pharmaceutical Academy with a degree in Pharmacy. Working in Clinical Research since 2018, starting as a Clinical Trial Assistant with administrative support for clinical trial operations, including study start-up, maintenance, and close-out activities. Joined IQVIA in September 2019 as a Clinical Research Associate (CRA) and later promoted to the role of Associate Clinical Lead. Starting in January 2020, performed Lead CRA responsibilities, such as offering direct support to study clinical leads and handling the procurement of study supplies. By 2022, became a Lead CRA for a Gastrointestinal (GI) study comprising 4 protocols.

In September 2022, as a participant in the Clinical Lead program, was assigned Clinical Lead tasks. These tasks included participating in customer-facing calls, overseeing county-level study deliveries, ensuring site compliance, and addressing quality and operational challenges, such as implementing local laboratory solutions and coordinating with vendors for additional study supplies. Moreover, mentored and supported newly appointed CRAs, assisted the regulatory team with study extension approvals, managed site insurance, conducted monthly site risk and finance reviews, and monitored protocol deviations.

Additionally, leadership experience includes being a trainer for IQVIA's CRA University program in 2022 and 2023. Therapeutic expertise: Gastroenterology (Ulcerative Colitis, Crohn's Disease), Neurology (Multiple Sclerosis, Parkinson's Disease), and Oncology (Non-Small Cell Lung Cancer, Diffuse Large B-cell Lymphoma, Polycythemia Vera). Also participated in a device trial involving a pump.

Overview

8
8
years of professional experience
5
5
years of post-secondary education
1
1
Certification

Work history

Clinical Lead

IQVIA
St.Petersburg, Russia
03.2024 - Current
  • Was responsible for 10 countries (EU, Turkey, South Africa and Israel), 3 GI protocols. 3 Audits and 2 RA inspections.
  • Accounting for the clinical delivery (subject recruitment, site management, data integrity) per contract, standard processes, policies and procedures.
  • Effective communication and assessment of performance against agreed goals.
  • Proactive monitoring of clinical progress and preparation/presentation project information to the client and stakeholders.
  • Delivering the project/program according to the quality management plan. Guidance CRAs on critical specific study issues.
  • Collaboration with other functional groups within the company to support milestone achievement and management of study issues and obstacles.
  • Management of risks (positive and negative) which could impact on the clinical delivery of the project and determine contingencies. Partner with functional leaders in problem solving and resolution efforts.

Lead CRA

IQVIA
St. Petersburg, Russia
01.2022 - 03.2024
  • Full range of CRA activities
  • Led local CRA team (17 sites, up to 5 CRAs)
  • Trained and mentoring new CRA on study procedures
  • Led and participated in sponsor calls (Russia, Belgium) and regional calls (EMEA region).
  • Used critical thinking to break down issues connected to logistics, local lab testing, evaluate solutions and make decisions.

Clinical Research Associate (CRA)

IQVIA
St.Petersburg, Russia
09.2019 - 01.2022


  • Performed site selection, initiation, monitoring and close-out in accordance with contracted scope of work, ICH GCP and local regulations.
  • Provided protocol and related study training to assigned sites and study team (including development of training materials)
  • Established regular communication with sites and project team for issue management and expectations
  • Management of appropriate documentations required for study purposes
  • Mentoring of clinical team members including conducting co-monitoring and training visits.
  • CTA assistance with documents and processes
  • Preparation for audits; CAPA management.

Clinical Trial Assistant (CTA)

PSI
St. Petersburg, Russia
08.2017 - 08.2018


  • Support the Clinical Trial Managers and CRAs to ensure optimal management of all documents with logistical and administrative tasks related to trial start-up, execution and closing of clinical trials
  • Organize meetings, take minutes and provide administrative support for investigator meetings
  • Setup and maintain TMF/eTMF, documents collection and quality check
  • Support the study team with distribution of site materials and equipment

Procurement Specialist

Geropharm
St. Petersburg, Russia
08.2017 - 08.2018
  • Facilitated communication between cross-functional teams for smooth procurement process.
  • Monitored inventory needs and worked with procurement team to facilitate supply chain operations.
  • Negotiated contract terms and awarded supplier contracts to achieve optimum business profits.
  • Delivered tactical cost savings by negotiating advantageous terms and conditions for new contracts.

Education

Master of Science - Pharmacy

Saint Petersburg Chemical Pharmaceutical Academy
St. Petersburg, Russia
09.2012 - 07.2017

Certificate of Higher Education - Clinical Trials

First Pavlov State Medical University
St. Petersburg, Russia
03.2018 - 05.2018

Skills

  • Effective communication
  • Teamwork
  • Resilience under pressure
  • Risk Management
  • Proactive approach
  • Advanced analytical thinking
  • Leadership skills
  • Risk mitigation
  • Project Management


Languages

English
Proficient (C2)
French
Elementary (A2)
Italian
Elementary (A2)
Russian
Native

Accomplishments

    IQVIA IMPACT PROGRAM (Bronze), 2023

    IQVIA IMPACT PROGRAM (Bronze), 2024

    Trainer at "CRA University", conducted by IQVIA and First Pavlov State Medical University of St. Petersburg

Certification

• IQVIA GCP Certification, 2020

• IQVIA GCP Certification, 2022

• Global Oncology Fundamentals for Monitors program , 2022

Affiliations

  • Sport, Sewing, Learning languages, Traveling

Timeline

Clinical Lead

IQVIA
03.2024 - Current

Lead CRA

IQVIA
01.2022 - 03.2024

Clinical Research Associate (CRA)

IQVIA
09.2019 - 01.2022

Certificate of Higher Education - Clinical Trials

First Pavlov State Medical University
03.2018 - 05.2018

Clinical Trial Assistant (CTA)

PSI
08.2017 - 08.2018

Procurement Specialist

Geropharm
08.2017 - 08.2018

Master of Science - Pharmacy

Saint Petersburg Chemical Pharmaceutical Academy
09.2012 - 07.2017

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Inna Ivolina