Mert Çetiner

Clinical Research Coordinator

For the past three years, I have been serving as a Clinical Research Coordinator in oncology clinical trials at Cerrahpaşa Faculty of Medicine under the leadership of Prof. Dr. Mustafa Özgüroğlu. I possess comprehensive experience in ICH-GCP compliance, site operations, regulatory processes, and sponsor communication within academic and industry-sponsored clinical research.

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7+

Active Studies

25+

Patients Managed

Since 2023

Clinical Research

MÇMert Çetiner

About

Professional Focus

I support oncology clinical trials at site level with a focus on operational accuracy, regulatory readiness and structured sponsor communication. My experience includes investigator budget planning, contract pre-assessment, ethics committee submissions, TITCK-related regulatory processes, site coordination, EDC / IWRS / CTMS management and collaboration with global sponsors including Janssen Research & Development, Regeneron and AstraZeneca.

  • ICH-GCP
  • TITCK
  • EDC
  • IWRS / IRT
  • CTMS
  • DrugDev
  • Budget Planning
  • Site Operations
  • Ethics Committee
  • Regulatory Submissions
  • Sponsor Communication
  • Query Resolution

Training & Platform Experience

Clinical Research Systems

EDC, ePRO, eCOA, CTMS, IRT and Medical Imaging Platforms

Medidata Rave

Medidata Rave

EDC

Signant Health

Signant Health

eCOA / ePRO

Clario

Clario

Imaging / eCOA

YPrime

YPrime

eCOA / IRT

Firecrest Clinical

Firecrest Clinical

Site Training

Calyx

Calyx

CTMS / Imaging

Ambra Health

Ambra Health

Medical Imaging

Teckro

Teckro

Site Communication

Clinical Research Training

ICH-GCP E6(R2)
ICH-GCP E6(R3)
Medidata Rave Training
Clario Platform Training
Signant Health Training
Firecrest Clinical Training
Sponsor-Specific Study Trainings

Additional certificates and training records available upon request.

Clinical Trial Experience

Active

Advanced Urothelial Carcinoma

Phase III•Janssen Research & Development

Advanced urothelial cancer study involving subjects with selected FGFR gene aberrations.

Active

Advanced / Metastatic NSCLC

Phase III•Janssen Research & Development

Study in advanced or metastatic non-small cell lung cancer.

Active

EGFR-Mutated NSCLC

Phase III•Janssen Research & Development

First-line treatment study in patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer.

Active

HRR Gene-Mutated mCSPC

Phase III•Janssen Research & Development

Randomized, placebo-controlled, double-blind study in HRR gene-mutated metastatic castration-sensitive prostate cancer.

Active

PD-L1 ≥50% Advanced NSCLC

Phase II/III•Regeneron

Randomized, double-blind study in patients with tumors expressing PD-L1 ≥50% advanced non-small cell lung cancer; EGFR, ALK and ROS1 negative.

Active

Resectable Early Stage NSCLC

Phase II•Regeneron

Peri-operative study in resectable early stage (Stage II to IIIB [N2]) non-small cell lung cancer.

Active

Metastatic Castration-Resistant Prostate Cancer

Phase III•Janssen Research & Development

Randomized, open-label comparative treatment study in metastatic castration-resistant prostate cancer.

References

Prof. Dr. Mustafa Özgüroğlu

Professor Doctor

Cerrahpaşa Faculty of Medicine

Bilge Berberoğlu

Senior Site Manager

Janssen Pharmaceuticals

Özge Can Gümüş

Clinical Research Associate

Janssen Pharmaceuticals

References available upon request.

Systems & Certifications

Systems & Platforms

  • Medidata Rave
  • IWRS / IRT
  • CTMS
  • DrugDev
  • EDC Systems
  • SAE / Safety Reporting
  • Microsoft Office
  • eTMF / ISF Document Tracking
  • Regulatory Submission Tracking
  • Clinical Trial Management Platforms

Compliance & Certifications

  • ICH-GCP
  • Ethics Committee Documentation
  • TITCK-Related Regulatory Processes
  • Site Monitoring Visit Preparation
  • Query Resolution
  • Source Document Tracking

Contact