Clinical Research Associate (Cra)

About the Role Location: Sevilla, Spain, Hybrid Working, #LI-Hybrid

This is a site relationship management role to ensure sustainable trial execution at Site. Performs on-site and remote monitoring activities related to initiation, conduct and timely completion of Phase I-IV Global Drug Development (GDD) trials within the country in adherence with monitoring procedures and processes in accordance with International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) / Good Clinical Practice (GCP), local regulations and Standard Operating Procedures (SOPs). Proactive site performance management (recruitment & quality) and early identification of real site needs and issues as the single best point of contact (internally & externally) for all sites. (From issue management to risk identification).
 
Key Responsibilities:
Your responsibilities include but are not limited to:
• Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables with true ownership mindset.
• Manages assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
• Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Re-trains site personnel as appropriate
• Conducts continuous site monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol ICH / GCP, global and local regulation including Health Authorities, Institutional Review Board (IRB) / Ethics Committee (EC), data privacy requirements, global and local processes as applicable. Documentation according to Good Development Practice (GDP) and Novartis standards.
• Promotes a compliance culture advocating adherence to the highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times.
• Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow-up activity and archiving requirements.
• Proactively collaborates with the Site & Study Operations (SSO) Clinical Project Managers (CPM) and CRA Managers as well as Medical Science Liaisons, Clinical Research Medical Advisors (CRMA) and medical advisors to ensure optimal recruitment, site development and data quality.
• Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines

Key Performance Indicators (KPIs)
• Next level of site collaboration measured by patient density at site, achievements of commitments and targets and deliver customer satisfaction results.
• Ensures the delivery of high-quality data according to agreed timelines with adherence to prevailing legislation, GCP, Ethical Committee and SOP requirements.
• Quality and timeliness of updating the Novartis systems, monitoring reports, and communication efforts as defined by global KPIs and key quality indicators (KQIs)
Essential Requirements:
• Degree in scientific or healthcare discipline
• Fluent in both written and spoken English and Spanish
• 2 years pharmaceutical industry experience or other relevant experience
• Central/in-house monitoring or field monitoring experience
• Knowledge of international standards (GCP/ICH, Food & Drug Administration (FDA), European Medicines Agency (EMA)
• Understanding the purpose of the CRA (Patient Safety; Data Integrity; Principal Investigator (PI) Oversight; GCP/ICH & Protocol Compliance)

Why Novartis?
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You'll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Key Responsibilities:
Your responsibilities include but are not limited to:
• Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables with true ownership mindset.
• Manages assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
• Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Re-trains site personnel as appropriate
• Conducts continuous site monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol ICH / GCP, global and local regulation including Health Authorities, Institutional Review Board (IRB) / Ethics Committee (EC), data privacy requirements, global and local processes as applicable. Documentation according to Good Development Practice (GDP) and Novartis standards.
• Promotes a compliance culture advocating adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times.
• Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements.
• Proactively collaborates with the Site & Study Operations (SSO) Clinical Project Managers (CPM) and CRA Managers as well as Medical Science Liaisons, Clinical Research Medical Advisors (CRMA) and medical advisors to ensure optimal recruitment, site development and data quality.
• Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines

Key Performance Indicators (KPIs)
• Next level of site collaboration measured by patient density at site, achievements of commitments and targets and deliver customer satisfaction results.
• Ensures the delivery of high-quality data according to agreed timelines with adherence to prevailing legislation, GCP, Ethical Committee and SOP requirements.
• Quality and timeliness of updating the Novartis systems, monitoring reports, and communication efforts as defined by global KPIs and key quality indicators (KQIs)
Essential Requirements:
• Degree in scientific or healthcare discipline
• Fluent in both written and spoken English and Spanish
• 2 years pharmaceutical industry experience or other relevant experience
• Central/in-house monitoring or field monitoring experience
• Knowledge of international standards (GCP/ICH, Food & Drug Administration (FDA), European Medicines Agency (EMA)
• Understanding the purpose of the CRA (Patient Safety; Data Integrity; Principal Investigator (PI) Oversight; GCP/ICH & Protocol Compliance)

Why Novartis?
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You'll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Division Development
Business Unit Pharmaceuticals
Location Spain
Site Barcelona Provincial
Company / Legal Entity ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.
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