Gabriela Nadiak
Broken Arrow,OK
Summary
Clinical Research professional with 15 years of progressive experience across clinical operations, clinical monitoring, site management, and team leadership, with extensive expertise in Oncology and Hematology. Strong background in site feasibility, selection, initiation, monitoring, and close-out activities across Phase I–IV clinical trials. Experienced in building and maintaining strong relationships with investigative sites, collaborating with cross-functional stakeholders, and ensuring compliance with ICH-GCP and regulatory requirements. Proven ability to identify and resolve operational challenges, drive study quality, support clinical trial milestones, and optimize site performance. Brings a comprehensive understanding of clinical trial execution from both site-level and operational leadership perspectives in CRO full service and sponsor dedicated models.
Overview
2
2
years of post-secondary education
15
15
years of professional experience
Work History
Clinical Operations Manager
IQVIA – Partnership with Eli-Lilly
09.2020 - Current
- Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work, assessing performance and guiding professional development, rewarding and disciplining employees, and addressing employee relations issues and resolving problems.
- Ensured that staff had the proper materials, systems access, and training to complete job responsibilities. Oversaw the execution of the training plan and SOP review.
- Manage the quality of assigned staff's clinical work through regular review and evaluation of work product.
- Identifies quality risks and issues and creates appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
- Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.
- Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training.
- Collaborated with clinical teams and functional leadership to address project-related challenges, enhancing customer service outcomes.
- Supported departmental quality and process improvement initiatives, contributing to organizational standards and efficiency.
- Conducted candidate reviews and interviews to select new employees, ensuring alignment with organizational needs.
Clinical Research Associate (Jr to Sr II)
IQVIA
08.2015 - 02.2022
- Conducted Pre-Site Selection Visits (PSSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs) across Phase I–IV clinical trials, ensuring compliance with study protocols, ICH-GCP guidelines, and applicable regulatory requirements.
- Managed investigative site activities throughout the clinical trial lifecycle, including site feasibility, selection, start-up, monitoring, and close-out, ensuring operational efficiency and adherence to study milestones.
- Supported site start-up activities, including regulatory document collection, submission tracking, site readiness assessments, and coordination with study teams.
- Established and maintained strong relationships with investigators and site personnel, facilitating ongoing operational support and effective resolution of study-related challenges to enhance site engagement.
- Delivered protocol-specific training to investigative site staff on study procedures, data collection, informed consent requirements, and safety reporting expectations.
- Reviewed informed consent documentation and monitored adverse events (AEs), serious adverse events (SAEs), and safety reporting compliance, ensuring participant safety and adherence to regulatory requirements.
- Monitored site performance, including patient recruitment and enrollment, protocol compliance, CRF completion, data quality, and timely resolution of data queries.
- Reviewed and maintained essential regulatory documentation, ensuring Trial Master File (TMF) and Investigator Site File (ISF) completeness and compliance.
- Identified and documented quality and compliance issues, collaborating with study teams and investigative sites to implement corrective and preventive actions, enhancing overall study integrity.
- Prepared monitoring visit reports, follow-up letters, and site management documentation, ensuring timely and accurate reporting of monitoring findings and action plans.
- Collaborated with cross-functional study teams to support successful clinical trial execution, with extensive experience in Oncology and Hematology.
- Mentored and trained clinical research staff through co-monitoring visits, training activities, official mentor and ongoing professional support.
- Mrs. Nadiak worked in studies of Phase I, Phase II and Phase III as a CRA in the therapeutic areas: Oncology (more experienced area), Hematology, Endocrinology, Immunology, Respiratory, Neurology and Rheumatology.
Clinical Trials Assistant
IQVIA
08.2013 - 07.2015
- Supported CTL and CRAs by updating and maintaining clinical systems to track site compliance and performance within project timelines.
- Facilitated preparation, handling, distribution, filing, and archiving of clinical documentation and reports, ensuring adherence to scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.
- Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
- Assist CTLs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Served as central contact for clinical team regarding project communications, correspondence, and associated documentation.
- Executed administrative tasks that supported team members during clinical trial execution.
Study Research Coordinator
CEPHO – Oncology and Hematology Clinical Research Site
11.2011 - 08.2013
- Conducted activities for start-up, regulatory, and maintenance periods.
- Ethics (local ethics committee) dossier submission, approval and follow-up.
- Participating in subject recruitment efforts.
- Coordinated patient scheduling for clinical appointments and trials.
- Coordinated handling and shipping of biological samples to central laboratories, ensuring compliance with regulatory standards.
- Collecting, coding and analyzing data obtained from research.
- Ensured proper filing of study documents to maintain compliance.
- Evaluated adverse events to ensure participant safety and compliance.
- Filing study documents.
- Preparation of patient's records.
- Case Report Form (CRF) completion.
- Handling and/or shipping biological samples to central laboratories.
- Adhering to research regulatory standards.
- Adhering to ethical standards.
- Maintaining detailed records of studies as per Regulatory Agencies guidelines, including things such as drug dispensation.
- Facilitated subject recruitment efforts, contributing to successful enrollment in clinical trials.
- Involved in 5 phase II studies and 18 phase III studies in the oncology field, focusing on breast, prostate, pulmonary, and digestive tract cancers.
Education
Post-Graduate Certificate - Oncology and Hematology
UNINTER - International University Center
Brazil 04.2019 - 07.2021
Bachelor's Degree - Pharmacy
FMABC - ABC School of Medicine
BrazilSkills
- Clinical operations
- Clinical trial management
- Site management
- Site monitoring
- Protocol compliance
- SOP compliance
- Regulatory documentation
- Quality oversight
- Patient safety monitoring
- Risk management
- Operational oversight
- Team leadership
- Resource management
- Critical thinking
Language:
English: Fluent., Portuguese: Fluent., Spanish: Business Level.
Publications:
"Exercise training (ET) in treadmill running reduces oxidative stress and inflammatory signaling of the commissural nucleus of the solitary tract (commNTS) and rostral ventrolateral medulla (RVLM) in normotensive rats". Study published in Brain Research Journal.
Other Relevant Information:
- GCP Accreditation Exam, 2016, 2018, 2020, 2022, 2025 and 2026(ICH GCP E6 R3).
- Barnett Accreditation – Fundamentals GCP Exam, 2011 to 2015.
- INVITARE - School of Clinical Research - Study Coordinator Certificate, 2013.
- Good Clinical Practices (GCP) Complete Course - Apr2012-Mar2013.
Timeline
Clinical Operations Manager
IQVIA – Partnership with Eli-Lilly
09.2020 - Current
Post-Graduate Certificate - Oncology and Hematology
UNINTER - International University Center
04.2019 - 07.2021
Clinical Research Associate (Jr to Sr II)
IQVIA
08.2015 - 02.2022
Clinical Trials Assistant
IQVIA
08.2013 - 07.2015
Study Research Coordinator
CEPHO – Oncology and Hematology Clinical Research Site
11.2011 - 08.2013
Bachelor's Degree - Pharmacy
FMABC - ABC School of Medicine