Clinical Research Associate I (Jr)

Novartis Farmacéutica; Brasil; Teletrabalho; BRL 40.000 - 80.000; Tempo integral

Resumo da oferta

An established industry player is seeking a dedicated Site Relationship Manager to ensure the successful execution of clinical trials. This role involves proactive site management, continuous monitoring, and collaboration with various stakeholders to enhance patient recruitment and data quality. The ideal candidate will possess a degree in a scientific or healthcare discipline and have field monitoring experience. Join a community of passionate professionals committed to making a difference in patients' lives and help shape the future of healthcare.

Qualificações

• Up to 2 years pharmaceutical industry experience or other relevant experience.
• Field monitoring experience is essential for this role.

Responsabilidades

• Conducts continuous site monitoring activities and manages assigned study sites.
• Establish a strong partnership with the site to increase patient density.

Conhecimentos

Clinical Monitoring/Research/Trials

Data Integrity

Decision Making Skills

Ability to travel

Ability to manage sites independently

Time management and organization capabilities

Formação académica

Degree in scientific or healthcare discipline

Descrição da oferta de emprego

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 GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and 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).

About the Role

Major accountabilities:

• Conducts continuous site monitoring activities (onsite and remote) and manages assigned study sites, conducting phase I-IV protocols. Implements site management activities to ensure compliance with protocol, ICH/GCP, global and local regulation including Health Authorities, IRB/EC, data privacy requirements, global and local processes as applicable. Documentation according to GDP and Novartis standards.
• Performs Site Initiation Visit and Site Closeout activities per SOPs and applicable regulations.
• Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables with true ownership mindset.
• Establish a strong partnership and true collaboration with the site, to increase patient density and decrease issues at site.
• Early engagement with site on patient inventory and patient flow in advance of SIV in close collaboration with global and local study team
• Proactively collaborates with the SSO Clinical Project Manager (CPM) and CRA Manager as well as MSL, CRMA and medical advisor 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.
• Ensures the site Investigator Folder is up to date. Responsible for collecting essential documents from site and accountable to keep sTMF(s) up to date.

Key performance indicators:

• Next level of site collaboration measured by patient density at site, achievements of commitments and targets and deliver customer satisfaction results.
• Meets study milestones.
• 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 KQIs
• Degree in scientific or healthcare discipline
• Field monitoring experience
• Operations Management and Execution.
• Up to 2 years pharmaceutical industry experience or other relevant experience

Skills:

• Clinical Monitoring/Research/Trials.
• Data Integrity.
• Decision Making Skills.
• Ability to travel.
• Ability to manage sites independently
• Time management and organization capabilities

Languages :

• English (Written and Spoken).

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

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