Clinical Research Associate

KAFI TAI

KATY, TX ***** 832-***-**** *********@*****.***

PROFESSIONAL SUMMARY

Dedicated Clinical Research Associate with a proven track record of excellence in the clinical research industry. Experience working on a wide range of clinical trials, including Phases I-IV studies. Proficient in all aspects of trial management, from site selection and initiation to data monitoring and regulatory compliance. Known for meticulous attention to detail, effective problem-solving, and exceptional organizational skills. Adept at fostering strong site relationships, ensuring data accuracy, and delivering results in alignment with study objectives. Committed to upholding the highest ethical and quality standards while driving clinical trial success.

THERAPEUTIC EXPERIENCE

CNS – Alzheimer's Disease, Parkinson's Disease

Oncology –Gastric Cancer, Breast Cancer, Colorectal Cancer, Cell and Gene Therapy, AML, CML

Medical Device – Heart Valve, IVD, Glucose Continuous Monitoring device

Dermatology - Psoriasis, Atopic Dermatitis

Cardiology – Essential Hypertension

Ophthalmology - Cataract, Dry Eyes

SKILLS

Site Selection and Initiation

Regulatory Compliance (GCP/ ICH, FDA)

Regulatory Submissions

Proficient in EDC, CTMS, IVRS and eTMF Systems.

Patient Recruitment Strategies

Clinical Trial Management

Site Selection and Initiation

Data collection and analysis

Cross-functional collaboration

Risk Assessment and Mitigation

WORK HISTORY

JULY 2021-CURRENT

Clinical Research Associate II PPD

Manage and execute multiple clinical trials, adhering to protocol guidelines, regulatory requirements, and GCP (Good Clinical Practice) standards.

Coordinate site initiation, monitoring, and closeout activities, ensuring compliance with study protocols and regulatory documentation.

Conduct site visits, including pre-study, initiation, routine monitoring, and closeout visits, maintaining clear communication with investigators and site staff.

Proficiently review and verify clinical trial data, source documents, and case report forms (CRFs) for accuracy and completeness.

Monitor subject enrollment, retention, and compliance to maintain study timelines and objectives.

Collaborate with cross-functional teams, including clinical operations, data management, and regulatory affairs, to ensure smooth trial execution.

Contribute to the preparation of clinical study reports, regulatory submissions, and responses to regulatory inquiries.

Assist in the preparation and organization of investigator meetings, training sessions, and site audits.

Maintain up-to-date knowledge of industry regulations, guidelines, and best practices to ensure study compliance.

APRIL 2019-JULY 2021

Clinical Research Associate I PPD

Provided essential support in the execution of clinical trials, including site initiation, monitoring, and closeout activities.

Assisted in the development of study protocols, informed consent forms (ICFs), and other study-related documents.

Conducted site visits to ensure protocol compliance, data quality, and subject safety.

Maintained and organized study-related documentation, including regulatory binders and essential documents.

Collaborated with study sites to facilitate subject recruitment and retention.

Assisted in the preparation of regulatory submissions and responses to regulatory queries.

Implemented electronic data capturing systems to adhere with clinical research guidelines.

Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.

NOVEMBER 2017-APRIL 2019

Research Coordinator Houston Methodist

Assisted in the development of research protocols, informed consent forms, and case report forms, ensuring adherence to regulatory standards.

Recruited, screened, and enrolled eligible participants, maintaining detailed study records and patient confidentiality.

Collaborated with multidisciplinary teams, including investigators, nurses, and data managers, to ensure smooth study operations.

Conducted patient visits and assessments, collected and managed study data, and facilitated follow-up visits.

Oversaw regulatory compliance, including IRB submissions, and ensured adherence to GCP, ICH, and institutional policies.

Trained and educated study staff, ensuring a comprehend e understanding of study protocols and procedures.

Performed data analysis, generated reports, and assisted in document preparation.

EDUCATION

Bachelor of Arts: English

UOL,

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