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Karen Avetisyan

@karenavetisyan

Clinical Research Associate at Crocus Medical CRO, supporting Phase I and III trials through database lock and regulatory submission readiness.

Uruguay

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At Crocus Medical CRO, I supported Phase I and Phase III clinical trials in ophthalmology, allergology, and oncology from study start-up through database lock and regulatory submission readiness. I oversaw site compliance and data quality, and worked with Data Management on query resolution and study readiness.

Previously, at KCR CRO, I monitored international Phase II and Phase III oncology trials and mentored newly hired Clinical Research Associates. My experience also includes sponsor-side clinical operations and pharmacovigilance at Pharmapark / Nativa, alongside a medical background and training in ICH-GCP.

Experience

Work history, roles, and key accomplishments

Senior Clinical Research Associate

Crocus Medical CRO

Dec 2024 - Sep 2026 (1 year 9 months)

Supported delivery of Phase I and Phase III clinical trials in ophthalmology, allergology, and oncology, from study start-up through database lock and regulatory submission readiness. Provided operational oversight of investigational sites, ensuring compliance with ICH-GCP and sponsor procedures.

Clinical Operations ICH GCP E CRF UAT SDV SDR Data Quality Safety Reporting Site management Study Start Up Regulatory Submissions

Clinical Research Associate

KCR CRO

Aug 2021 - Sep 2024 (3 years 1 month)

Monitored Phase II and Phase III international clinical trials in oncology, collaborating with site personnel and ensuring compliance with protocol requirements. Mentored newly hired CRAs and supported interactions with Ethics Committees.

Clinical Monitoring Oncology ICH GCP EPRO Site management Ethics Committees AE SAE Reporting Mentorship

Clinical Research Associate

PRA CRO

Feb 2020 - Aug 2021 (1 year 6 months)

Monitored Phase II-IV clinical trials in cardiology, neurology, and autoimmune diseases, managing the full site monitoring lifecycle. Prepared sites for audits and inspections and coordinated Ethics Committee communications.

Clinical Monitoring Site management ICH GCP Patient Recruitment Ethics Committees AE SAE Reporting Training Remote Monitoring

Clinical Research Associate / Pharmacovigilance Responsible Person

Pharmapark / Nativa

Apr 2018 - Feb 2020 (1 year 10 months)

Supported sponsor oversight of Phase I-III clinical trials, including eCRF development, vendor management, and study start-up. Managed SAE collection, safety database maintenance, and regulatory submissions.

Clinical Operations Pharmacovigilance E CRF Vendor Management Regulatory Submissions SAE Reporting Safety Database Management Site Selection Budget Management

Clinical Research Associate

Smooth Drug Development CRO

Jan 2017 - Apr 2018 (1 year 3 months)

Monitored Phase II-III clinical trials in infectious diseases and gynecology, performing site selection, initiation, monitoring, and close-out visits. Coordinated budgets, contracts, and Ethics Committee interactions.

Clinical Monitoring Site management ICH GCP Budget Management Contract Negotiation Ethics Committees AE SAE Reporting Patient Recruitment

Therapist (General Practitioner)

State Clinic No. 214, Branch 1

Nov 2016 - Dec 2016 (1 month)

Provided outpatient medical care and patient management in accordance with clinical guidelines. Maintained accurate electronic medical records and developed individualized treatment plans.

Patient Care Clinical Documentation Treatment Planning Electronic Medical Records

Marketing Auditor / Territorial Medical Representative

SBL-pharma

Jan 2014 - Jul 2016 (2 years 6 months)

Conducted field performance assessments of medical representatives and analyzed physician prescribing patterns. Promoted pharmaceutical products to healthcare professionals and managed territory planning.

Market Analysis Field Auditing Product Promotion Relationship Management Territory Management Reporting