Senior Cra

buscojobs España; Barcelona; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

A leading clinical research organization is seeking a Senior Clinical Research Associate with extensive knowledge in Oncology. The role involves monitoring clinical trial sites, ensuring compliance with guidelines, and building strong relationships with investigators. Candidates should have a Bachelor's degree and significant experience in the pharma or clinical research industry. Fluency in English and Spanish is required.

Formación

• 4+ years healthcare experience in pharma or clinical research.
• Minimum 3-4 years monitoring and site management experience.

Responsabilidades

• Monitor multiple Phase I, II, III & IV clinical trial sites.
• Ensure adherence to GCP / ICH practices.
• Review source data to CRF / eCRF for patient safety.

Conocimientos

Oncology

Customer Service

Attention to Detail

Technical Skills

Educación

Bachelor’s Degree

Herramientas

CTMS

eCRF

eTMF

Descripción del empleo

As a Sr CRA, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You’ll utilise your extensive therapeutic knowledge in Oncology to oversee uniquely-focused clinical studies. Working at the core of clinical research, you’ll be exposed to cutting-edge protocols and experience a dedicated partnership with your team like never before.

Responsibilities

What you will be doing :

1. You will monitor multiple Phase I, II, III & IV clinical trial sites.
2. You will utilise your customer service mindset with your sites focusing on delivering value, building loyalty and trust to create a positive impact and strong relationship with investigators and study coordinators where respect, knowledge and commitment to ICH / GCP guidelines are key to successful trial conduct.
3. As the CRA, you are the main sponsor representative, providing key project updates. You will collaborate with the team, developing commitment to study timelines and objectives through regular visits with site staff in-person and remotely.
4. You will be the first to review source data to CRF / eCRF, ensuring patient safety and data integrity.
5. As the first point of contact for study sites, you will escalate any concerns / issues to other departments including Safety, Investigational Medicinal Product, Local Study Managers, and management team as appropriate.
6. Additionally, you will oversee the sites' adherence to GCP / ICH practices, ensuring the quality of study conduct.

Qualifications

You are :

• Bachelor’s Degree (or equivalent) with +4 years of relevant healthcare experience in the pharma or clinical research industry. Minimum 3 / 4 years of monitoring and site management experience.
• TA : Oncology
• Scientific background
• Proficiency with medical terminology
• Working knowledge of Local Regulations
• A demonstrated working knowledge of ICH / GCP Guidelines
• Excellent record-keeping skills and attention to detail
• Experience conducting Site Selection, Initiation, Routine Monitoring, and Close Out Visits both remotely and on-site
• Fluent in English, both written and oral, and local language (Spanish)
• Strong technical skills with CTMS, eCRF, eTMF