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Clinical Research Associate

hace 1 mes


Gasteiz Vitoria, Álava, España Pharmiweb A tiempo completo
Job Title: Clinical Research Associate

Job Summary:
We are seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Key Responsibilities:
Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits
Evaluate overall performance of site and site staff and provide recommendations
Maintain a working knowledge of ICH/GCP Guidelines and relevant regulations
Verify informed consent process and protect subject/patient confidentiality
Assess factors affecting subject/patient safety and clinical data integrity
Document activities via confirmation letters, follow-up letters, trip reports, and other required project documents

Requirements:
Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Excellent communication, presentation, and interpersonal skills
Ability to manage required travel of up to 75% on a regular basis

About Us:
We are a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do.