Open to opportunities

Mehul Goswami

@mehulgoswami

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Clinical Research professional experienced in SDV, PK monitoring, SAS programming, and on-site CRA activities.

India

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What I'm looking for

I seek CRA roles with extensive on-site monitoring, strong regulatory compliance, opportunities to use SAS/data skills, travel flexibility, and career growth in clinical operations.

I am a Clinical Research professional with 3.5+ years' experience as a Clinical Research Coordinator and Jr. Quality Reviewer, with hands-on exposure to site monitoring, SDV and in-process PK monitoring across multiple therapeutic areas.

I have supported setup of new sites, managed multi-site operations, and participated in regulatory inspections, including a USFDA inspection. I maintain regulatory compliance with ICH-GCP, NDCTR and SOPs while ensuring data integrity.

I am SAS certified (Base and Advanced in SAS 9.4) and proficient with SAS BASE, SAS SQL, SAS MACRO, PROC reporting procedures and EDC systems, enabling robust data cleaning, merging and reporting for clinical databases.

I am flexible and highly motivated to travel extensively for on-site monitoring as a CRA, and committed to expanding expertise in clinical research, regulatory submissions and project management to contribute to successful trial execution.

Experience

Work history, roles, and key accomplishments

Current

Jr. Quality Reviewer

Current

Cliantha Research Limited

Oct 2024 - Present (1 year 1 month)

Monitored clinical trial data as a QC Monitor across multiple Indian sites, performing in-process PK monitoring and SDV to ensure GCP compliance; accumulated 150+ monitoring days and assisted SOP development for data quality control.

PK Data Monitoring ICH GCP SAS 9.4 Query Management Regulatory Compliance

Clinical Research Coordinator II

Vitely Bio LLP

May 2022 - Oct 2024 (2 years 5 months)

Coordinated multiple clinical trial sites, initiated 5+ new sites and supported US FDA inspection readiness; managed participant screening, informed consent, CRF review, safety reporting, and maintained trial documentation.

Site Initiation CRFs Review EDC Patient Recruitment

Clinical Research Coordinator I

Shreeji Psychiatric Hospital

May 2021 - May 2022 (1 year)

Supported execution of patient-based PK and phase trials including screening, data collection, and site visits; maintained study databases, logs for AEs/SAEs/concomitant meds, and contributed to interim reports.

Data Collection AE SAE Documentation GCP