How are pediatric participants involved in research?

Special ethical considerations and parental consent are required for involving children in clinical research.

How are vulnerable populations protected in clinical research?

Extra precautions are taken to ensure that vulnerable populations, such as the elderly or those with cognitive impairments, are protected.

What is compassionate use in clinical research?

Compassionate use allows patients with serious conditions to access experimental treatments outside of clinical trials.

How does globalization affect clinical research?

Globalization leads to the conduct of multinational studies, increasing diversity and relevance of the results.

What are the future trends in clinical research?

Advancements in personalized medicine, AI, and digital health technologies are shaping the future of clinical research.

As Clinical Research Associate and freelance clinical research consultant with strong experience in global Phase I to Phase III clinical trials.

🧪 I specialize in oncology, CAR T cell therapy, cardiology, and autoimmune disease studies. My expertise includes site monitoring, risk based monitoring, regulatory compliance, and clinical data quality management in line with ICH GCP standards.

🏥 My career began as a Site Coordinator at Medex SMO and continued with CRA and Senior CRA roles at Medex CRO, IQVIA, and Ascot Science, contributing to high impact Phase II and Phase III clinical trials.

🚀 Currently, I work as an independent freelance CRA and clinical research consultant, supporting CROs, sponsors, investigator sites, and biotech companies with study startup, site readiness, remote and on site monitoring, audit readiness, and GCP compliance consulting.

🎓 I am also a PhD candidate in Biology, with a strong academic background in genomics, bioinformatics, and omics based research, combining scientific depth with operational excellence.

🌍 Open to freelance, remote, and project based collaborations worldwide.

Clinical Research Experience

🧪 Scientific Trust and Operational Excellence in Clinical Research

PHASE 1

2022-2023: DC25-1A CAR-T (Phase I/IIa) Multiple Myeloma - Clinical Research Associate (CRA)

2023-Present: MG-001 (Phase Ib/II) - Clinical Research Associate 2

Blue ring with the word PHASE in white against a black background.

Ayrıntılar

PHASE 3

2023-Present: PZN-127-03 (Phase III) - Clinical Research Associate 2

2023-2023: Horizon01 – Lung Cancer (Phase III) - Clinical Research Associate 2

2023-2023: INOVA 120-WO41554 Breast Cancer (Phase III) - Clinical Research Associate 2

2021-2023: I6T-MC-AMAM - Crohn Disease (Phase III) - Site Coordinator

2021-2023: I6T-MC-AMAX - Crohn Disease (Phase III) - Site Coordinator

2021-2023: GA29145 (Phase III) - Site Coordinator

2021-2023: APD334-303 (Phase III) - Site Coordinator

2021-2022: APD334-302 (Phase III) - Site Coordinator

Ayrıntılar

PHASE 2

2024-Present: DC08-SLE-001 CAR-T (Phase IIa) - Clinical Research Associate 2
2023-2024: Intercept 747-214 (Phase IIa) - Clinical Research Associate 2
2022-2023: DC-08 CAR-T (Phase II) - Clinical Research Associate (CRA)
2020-2021: B7981007 (Phase II) - Site Coordinator
2020-2021: B7981005 (Phase II) - Site Coordinator
2021-2023: APD334-202 (Phase II) - Site Coordinator

Ayrıntılar

PHASE 3

2021-2022: 261203 (Phase III) - Site Coordinator

2021-2023: HS0003 (Phase III) - Site Coordinator

2021-2023: TCH-306 (Phase III) - Site Coordinator

2021-2021: HS-18-633 (Phase III) - Site Coordinator
2021-2021: HS-19-647 (Phase III) - Site Coordinator

2020-2023: C3601002 (Phase III) - Site Coordinator
2020-2022: CT-P13_3.8 (Phase III) - Site Coordinator

2019-2023: AR-301 (Phase III) - Site Coordinator

2018-2021: ALX0681-C301 (HERCULES) (Phase III) - Site Coordinator

2023-Present: MG-001 (Phase Ib/II) - Clinical Research Associate 2

Ayrıntılar

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Frequently asked questions

Special Considerations

General Information and Definition

Participation and Process

Safety and Ethics

Types of Research

Legal and Regulatory Issues

Rights and Responsibilities of Participants

Impact and Outcomes of Research

Research Design and Implementation

Management and Oversight of Research

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