Sponsor Clinical Research Associate Senior Expert

Há 1 mês

Lisboa, Lisboa, Portugal Phiture Tempo inteiro

Job Summary

Syneos Health is a leading biopharmaceutical company dedicated to accelerating customer success. We're seeking a highly skilled Senior Clinical Research Associate to join our team. As a Senior Clinical Research Associate, you will be responsible for ensuring regulatory compliance and protocol adherence at investigator sites. Your primary focus will be on site qualification, site initiation, interim monitoring, site management, and close-out visits. You will also be responsible for maintaining a working knowledge of ICH/GCP guidelines, relevant regulations, and company SOPs/processes. Additionally, you will verify the process of obtaining informed consent and demonstrate diligence in protecting subject confidentiality. This role requires excellent communication, presentation, and interpersonal skills, as well as the ability to manage required travel of up to 75% on a regular basis. If you have a strong background in clinical research and are passionate about delivering high-quality results, we encourage you to apply for this exciting opportunity.

Key Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory compliance and protocol adherence
• Maintains a working knowledge of ICH/GCP guidelines, relevant regulations, and company SOPs/processes
• Verifies the process of obtaining informed consent and demonstrates diligence in protecting subject confidentiality
• Utilizes available hardware and software to support the effective conduct of clinical study data review and capture
• Collaborates with project site personnel and ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements
• Participates in global clinical monitoring/project staff meetings and attends clinical training sessions as required
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
• May perform training or mentorship to more junior level CRAs and may be mentored and assigned clinical operations lead tasks under supervision

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
• Ability to quickly adapt to changing priorities to achieve goals/targets

Why Syneos Health

We are passionate about developing our people through career development and progression, technical and therapeutic area training, peer recognition, and a total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We continuously build the company we all want to work for and our customers want to work with. By bringing together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels like they belong. Syneos Health is a leading biopharmaceutical company that has worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. We are passionate about delivering high-quality results and taking the initiative to challenge the status quo in a highly competitive and ever-changing environment. Learn more about Syneos Health and discover how you can make a difference with us.

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