Open to opportunities

Darshan Sh

@darshansh

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Clinical research professional with hands-on site and safety expertise.

India

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What I'm looking for

I seek a clinical research role where I can apply hands-on site operations and safety reporting skills, work within ICH-GCP/NDCT-compliant teams, support monitoring and inspections, and grow into larger operations or regulatory responsibilities.

I am a clinical research professional with approximately two years of combined experience as a Clinical Research Coordinator and Research Associate, supporting Phase I & II medical device and drug trials in hospital and sponsor-driven settings.

I hold an M.Pharm in Pharmacology and bring solid scientific and pharmacological understanding to trial execution, with strong familiarity with ICH-GCP E6(R2), NDCT Rules 2019, ALCOA++ principles, eTMF/ISF management, CRF review, SDV support, and AE/SAE reporting.

I consistently ensure protocol adherence, inspection readiness, and cross-team coordination—working with CRAs, sponsors, clinical teams, and ethics committees to maintain data integrity and support monitoring, CAPA, and regulatory requirements.

Experience

Work history, roles, and key accomplishments

Current

Research Associate

Current

Dozee (Turtle Shell Technologies Pvt. Ltd.)

Jan 2025 - Present (1 year)

Supported Phase I & II medical device clinical trials, managing patient screening, informed consent, visit coordination, source documentation, CRF review, SDV support, eTMF/ISF maintenance, and AE/SAE reporting to ensure monitoring and audit readiness.

Clinical Trial Management ETMF CRFs Review Monitoring Regulatory Compliance

Clinical Research Coordinator

Zenith Clinical Services

Mar 2024 - Nov 2024 (8 months)

Coordinated nephrology drug trials overseeing protocol adherence, visit scheduling, ICF management per ALCOA++, AE/SAE reporting and follow-up, IP accountability, sample collection/shipments, and monitoring/CAPA support.

Site management IP Accountability CAPA

QC/QA Trainee

Juggat Pharma

Dec 2023 - Jan 2024 (1 month)

Underwent industrial training with exposure to GMP, quality control and quality assurance processes across tablet, liquid, parenteral, and nutraceutical manufacturing.

Quality Control Quality Assurance Manufacturing Processes Documentation

Pharmacist Intern

Ramakrishna Hospital

Jan 2023 - Feb 2023 (1 month)

Assisted in prescription review, medication dispensing, patient counseling, and maintained pharmacy documentation per hospital SOPs to support clinical care operations.

Prescription Patient Counseling SOPs

Education

Degrees, certifications, and relevant coursework

Rajiv Gandhi University of Health Sciences, Bangalore

Master of Pharmacy, Pharmacology

2023 -

Activities and societies: Conducted preclinical pharmacological study on anti-inflammatory activity in Wistar rats; coursework and research projects related to pharmacology.

Master of Pharmacy (Pharmacology) program focused on pharmacological principles and preclinical/clinical research methodologies.