Clinical Research Associate

hace 4 meses

Buenos Aires, Argentina Novartis A tiempo completo

100,000. That’s how many patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) touches patients’ lives every day acting as a link between science and medicine. Envision the impact you could have #GCO
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).

**Your responsibilities include, but are not limited to**:

- 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, IRB/EC, data privacy requirements, global and local processes as applicable. Documentation according to GDP and Novartis standards.
- 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 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
- Collaborates with internal stakeholders and site personnel to manage data query resolution process and to ensure timely and accurate data entry
- 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

**What you’ll bring to the role**:
Fast change adaptability to best partner & influencing with sites on fast changing landscape
- Trust and rapport building is a very important skill needed
- Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings.
- A minimum of 50% overnight travel may be required
- Good communication skills, ability to influence others & Relationship management
- Excellent communicator and presenter (oral and written)
- Ability to manage sites independently; Proven ability to work independently with mínimal supervision
- Good analytical thinking
- Ability to anticipate potential issues and take appropriate actions with or without supervision
- Digital & tech capabilities, including computer skills (Microsoft platforms)

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

**Required Experience & Qualifications**:
**Education**:

- Degree in scientific or healthcare discipline (or, for United States: 4-year degree plus relevant, related healthcare experience).

Languages:

- Fluent in both written and spoken English and country language

Experience/Professional requirement:

- 2 years pharmaceutical industry experience or other relevant experience
- Central/in-house monitoring or field monitoring experience is desirable

**#GCO**

**Why Novartis?**

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
Imagine what you could do here at Novartis

**Commitment to Diversity & Inclusion**:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

**Division**

Global Drug Development

**Business Unit**

GCO

  • Clinical Research Associate

    hace 4 días

    Buenos Aires, Argentina CDS Fortrea Inc. A tiempo completo

    Job Title: Clinical Research AssociateAs a Clinical Research Associate at CDS Fortrea Inc., you will play a critical role in the success of our clinical trials. We are seeking a highly motivated and detail-oriented individual to join our team as a Clinical Research Associate.Key Responsibilities:Conduct site monitoring visits to ensure compliance with study...

  • Clinical Research Associate

    hace 3 semanas

    Buenos Aires, Argentina IQVIA Argentina A tiempo completo

    Job OverviewWe are seeking a highly skilled Clinical Research Associate to join our team at IQVIA Argentina. As a Clinical Research Associate, you will be responsible for ensuring the quality and integrity of study site practices related to the proper conduct of clinical trials.Key ResponsibilitiesSite MonitoringPerform site monitoring visits to ensure...

  • Clinical Research Associate

    hace 2 semanas

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    About the RoleWe are seeking a highly skilled Clinical Research Associate to join our team at Thermo Fisher Scientific. As a Clinical Research Associate, you will play a critical role in ensuring the success of our clinical trials by monitoring and managing site processes, conducting remote or on-site visits, and ensuring compliance with regulatory...

  • Clinical Research Associate

    hace 3 meses

    Buenos Aires, Argentina Worldwide Clinical Trials A tiempo completo

    **Requisition Number** **6764** **Employment Type***: **Regular** **Who we are** We’re a global, midsize CRO that pushes boundaries, innovates, and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with...

  • Clinical Research Associate

    hace 1 semana

    Buenos Aires, Argentina CDS Fortrea Inc. A tiempo completo

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at CDS Fortrea Inc. As a Clinical Research Associate, you will be responsible for monitoring clinical sites, maintaining study files, and conducting pre-study and initiation visits. You will also be responsible for ensuring the integrity of data submitted on Case Report...

  • Senior Clinical Research Associate

    hace 1 semana

    Buenos Aires, Argentina IQVIA A tiempo completo

    Job Title: Senior Clinical Research AssociateWe are seeking a highly skilled and experienced Senior Clinical Research Associate to join our team at IQVIA in Argentina. As a Senior CRA, you will be responsible for overseeing the progress of clinical investigations, conducting site evaluation and initiation visits, and monitoring clinical trials in accordance...

  • Clinical Research Associate

    hace 2 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    {"title": "Clinical Research Associate", "content": "Key ResponsibilitiesAs a Clinical Research Associate at IQVIA, you will be responsible for performing site selection, initiation, monitoring, and close-out visits, as well as maintaining appropriate documentation.Additionally, you will support the development of a subject recruitment plan, establish...

  • Clinical Research Associate

    hace 2 semanas

    Buenos Aires, Argentina Psi CRO Ag A tiempo completo

    {"h3": "Clinical Research Associate Role Overview"} We are a dynamic, global company that brings together passionate individuals to work on the frontline of medical science, changing lives and bringing new medicines to those who need them. Key Responsibilities Conduct selection, initiation, routine and closeout monitoring visits to ensure compliance with...

  • Senior Clinical Research Associate

    hace 3 días

    Buenos Aires, Argentina PSI A tiempo completo

    Job Title: Senior Clinical Research AssociateJob Summary:We are seeking a highly skilled Senior Clinical Research Associate to join our team at PSI. As a key member of our clinical research team, you will be responsible for conducting onsite monitoring visits, reviewing CRFs, and communicating with internal project teams.Key Responsibilities:Conduct and...

  • Clinical Research Associate

    hace 2 días

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    About the RoleAt Thermo Fisher Scientific, we're committed to making the world a healthier, cleaner, and safer place. As a Clinical Research Associate, you'll play a critical role in helping us achieve this mission.Key ResponsibilitiesConduct on-site visits to assess protocol and regulatory complianceManage required documentation and ensure audit...

  • Senior Clinical Research Associate

    hace 4 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    Job DescriptionJob SummaryIQVIA is seeking a highly skilled Senior Clinical Research Associate to join our team. As a Senior Clinical Research Associate, you will be responsible for overseeing the preparation and execution of Phase I-IV clinical trials, conducting site evaluation and initiation visits, and monitoring clinical trials in accordance with Good...

  • Clinical Research Associate

    hace 2 semanas

    Buenos Aires, Argentina MSD A tiempo completo

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at MSD. As a Clinical Research Associate, you will be responsible for ensuring the smooth conduct of clinical trials at assigned sites, ensuring compliance with regulatory requirements, and maintaining strong relationships with site staff.Key ResponsibilitiesDevelop and...

  • Clinical Research Associate

    hace 2 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    Career Advancement OpportunitiesAre you looking to take your career to the next level as a Clinical Research Associate? We offer a comprehensive training program to help you develop the skills and expertise needed to succeed in this role.As a CRA, you will be responsible for conducting site visits, monitoring clinical trials, and ensuring compliance with...

  • Clinical Research Associate

    hace 2 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    Job OverviewWe are seeking a highly skilled Clinical Research Associate to join our team at IQVIA. As a Clinical Research Associate, you will be responsible for ensuring that sites are conducting studies and reporting data as required by the study protocol, applicable regulations, and sponsor requirements.Key ResponsibilitiesSite MonitoringPerform site...

  • Clinical Research Associate

    hace 2 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    About the RoleWe are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team. As a CRA, you will play a critical role in ensuring the success of our clinical trials by conducting site visits, monitoring study progress, and maintaining accurate documentation.Key ResponsibilitiesPerform site selection, initiation,...

  • Senior Clinical Research Associate

    hace 3 semanas

    Buenos Aires, Argentina PSI A tiempo completo

    Job OverviewWe are seeking a highly skilled Clinical Research Associate to join our team at PSI. As a Clinical Research Associate, you will play a critical role in the success of our clinical research projects.Key ResponsibilitiesConduct and report all types of onsite monitoring visits, ensuring compliance with regulatory requirements and study protocols.Be...

  • Clinical Research Associate II Specialist

    hace 3 semanas

    Buenos Aires, Argentina Icon plc A tiempo completo

    About ICON plcICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.We are currently seeking a Clinical Research Associate II Specialist to join our...

  • Experienced Clinical Research Associate

    hace 4 meses

    Buenos Aires, Argentina Medpace, Inc. A tiempo completo

    Job Summary: The Clinical Research Associate at Medpace is offering the unique opportunity to have an **exciting career** in the research of drug and medical device development. For those with **medical and/or health/life science interest and background** who want to explore the research field, **travel throughout Argentina**, and be part of a team...

  • Experienced Clinical Research Associate

    hace 4 meses

    Buenos Aires, Argentina Medpace, Inc. A tiempo completo

    Job Summary: Join Medpace in Argentina! The Clinical Research Associate position at Medpace is offering the unique opportunity to have an **exciting career** in the research of drug and medical device development. For those with **medical and/or health/life science interest and background** who want to explore the research field, **travel throughout...

  • Clinical Research Associate

    hace 3 semanas

    Buenos Aires, Argentina MSD A tiempo completo

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at MSD. As a Clinical Research Associate, you will be responsible for ensuring the successful conduct of clinical trials in accordance with Good Clinical Practice (GCP) and regulatory requirements.Key ResponsibilitiesSite ManagementDevelop and maintain strong...