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Serm Associate Medical Director

Gsk Plc
GSK plc
8–12+ years
PLN 318,000 – PLN 530,000 per year
Warsaw, Poland
10 March 14, 2026
Job Description
Job Type: Full Time Education: MD/BDS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

Position Summary
The Clinical Research Associate II (CRA II) is responsible for monitoring clinical trials to ensure they are conducted in compliance with approved protocols, regulatory guidelines, and Good Clinical Practice (GCP) standards. The role supports the successful execution of clinical studies by coordinating with investigators, clinical sites, and internal teams to maintain data integrity and participant safety throughout the study lifecycle.

Key Responsibilities

Monitor clinical trial sites to ensure compliance with study protocols, regulatory requirements, and GCP guidelines

Conduct site initiation, monitoring, and close-out visits according to the clinical trial plan

Review clinical trial documentation including informed consent forms, source data, and case report forms

Ensure accurate and timely data collection and verification during the trial process

Coordinate with investigators, site staff, and internal project teams to resolve study-related issues

Maintain and update Trial Master File (TMF) documentation as required

Track study progress and report findings to the clinical project management team

Ensure proper reporting of adverse events and safety information during the study

Support preparation for audits and regulatory inspections

Professional Experience Requirements

2–3 years of experience in clinical trial monitoring or clinical research operations

Strong knowledge of ICH-GCP guidelines and clinical research regulations

Experience in site monitoring, documentation review, and clinical data verification

Ability to manage multiple clinical sites and maintain communication with investigators and study teams

Apply Details

Send your CV to:
career@prorelixresearch.com