Open to opportunities

Ching Fang Cheng

@chingfangcheng

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Clinical Research Associate with expertise in study site monitoring.

Taiwan

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What I'm looking for

I am seeking a role that fosters growth in clinical research and offers opportunities to enhance patient safety and data integrity.

I am a dedicated Clinical Research Associate with extensive experience in clinical trial monitoring and management. Currently, I work at Fortrea, where I am responsible for ensuring the integrity and compliance of clinical studies. My role involves meticulous monitoring of study sites, maintaining the Electronic Trial Master File (eTMF), and safeguarding patient safety through adherence to regulatory standards.

Throughout my career, I have successfully managed pharmacy operations and clinical supplies, achieving successful inspections with no findings. My previous experience as a Clinical Research Associate I allowed me to develop strong skills in data integrity and risk management, ensuring that all study procedures adhered to protocols. I have a solid background in research, having worked as a Research Assistant in a neurology department, where I contributed to subject recruitment and data collection.

Experience

Work history, roles, and key accomplishments

Current

Clinical Research Associate II

Current

Fortrea (Formerly Labcorp) Cooperation

May 2023 - Present (2 years 2 months)

Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits and database lock for interim analysis. Ensure the completeness, accuracy, and timely update of the Electronic Trial master File (eTMF), by regularly reviewing uploaded documents, resolving discrepancies, and maint

Monitoring Clinical Trials ETMF Regulatory Compliance Data Management SAE Reporting Pharmacy Management TFDA Inspection

Clinical Research Associate I

Fortrea (Formerly Labcorp) Cooperation

Oct 2019 - Present (5 years 9 months)

Oversaw unblinded component of study site monitoring including routine monitoring and site close-out activities. Collaborated with blinded team and sites to ensure study procedures adhered to blinded protocols.

Pharmacy File Maintenance Drug Accountability Data Integrity Inventory Management

Research Assistant

Wan Fang Hospital - Neurology Department

Oct 2018 - Present (6 years 9 months)

Participated in subject recruitment and assisted in Informed Consent explanation to ensure subject comprehension and facilitate documentation of consent. Oversee administrations of investigational medications and support subject assessments during clinical visits.

Investigational Medications IRB Submission