Sr. Cra 1

hace 4 semanas

Buenos Aires, Argentina Novasyte A tiempo completo

Job Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

**Qualifications**:

- Bachelor's Degree Degree in scientific discipline or health care preferred. Req
- Requires at least 2 years of year of on-site monitoring experience. Req
- Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
- i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

  • Sr Cra

    hace 1 semana

    Buenos Aires, Argentina ReSolution Latin America A tiempo completo

    As part of our continued expansion, ReSolution Latin America, a specialized CRO with operations across the Latin American region is looking for SR CRAs with experience in oncology, to join our growing team in Argentina If you thrive working in a positive, can do environment where your contribution makes a real difference and want to further your career in...

  • Sr Cra

    hace 2 semanas

    Buenos Aires, Argentina ReSolution Latin America A tiempo completo

    As part of our continued expansion, ReSolution Latin America, a specialized CRO with operations across the Latin American region is looking for SR CRAs with experience in oncology, to join our growing team in ArgentinaIf you thrive working in a positive, can do environment where your contribution makes a real difference and want to further your career in an...

  • Sr Cra 1

    hace 7 días

    Buenos Aires, Argentina IQVIA A tiempo completo

    Whether you’re beginning or continuing your career as a CRA, this role is an ideal stepping-stone. You’ll have training and development to plan and progress your career in the direction you choose. And you won’t do it alone - you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion and bonus awards. Award...

  • Cra (Level I)

    hace 3 semanas

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    CRA I or CRA II (1-2 years of experience)

  • Sr Cra 1

    hace 7 días

    Buenos Aires, Argentina Novasyte A tiempo completo

    Whether you’re beginning or continuing your career as a CRA, this role is an ideal stepping-stone. You’ll have training and development to plan and progress your career in the direction you choose. And you won’t do it alone - you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion and bonus awards. - Award...

  • Cra 1

    hace 5 días

    Buenos Aires, Argentina IQVIA A tiempo completo

    Whether you’re beginning or continuing your career as a CRA, this role is an ideal stepping-stone. You’ll have training and development to plan and progress your career in the direction you choose. And you won’t do it alone - you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion and bonus awards. Award...

  • Sr Cra 1

    hace 2 semanas

    Buenos Aires, Argentina Novasyte A tiempo completo

    Whether you're beginning or continuing your career as a CRA, this role is an ideal stepping-stone. You'll have training and development to plan and progress your career in the direction you choose. And you won't do it alone - you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion and bonus awards. Award winning...

  • Cra 1

    hace 2 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    Whether you're beginning or continuing your career as a CRA, this role is an ideal stepping-stone. You'll have training and development to plan and progress your career in the direction you choose. And you won't do it alone - you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion and bonus awards.Award winning...

  • Cra 1

    hace 5 días

    Buenos Aires, Argentina Novasyte A tiempo completo

    Whether you’re beginning or continuing your career as a CRA, this role is an ideal stepping-stone. You’ll have training and development to plan and progress your career in the direction you choose. And you won’t do it alone - you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion and bonus awards. Award...

  • Cra 1

    hace 2 semanas

    Buenos Aires, Argentina Novasyte A tiempo completo

    Whether you're beginning or continuing your career as a CRA, this role is an ideal stepping-stone. You'll have training and development to plan and progress your career in the direction you choose. And you won't do it alone - you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion and bonus awards.Award winning...

  • Cra (Level Ii)

    hace 3 semanas

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    CRA with 1 year of experience in field monitoring - FSP position - Sponsor GSK

  • Sr. Cra 1

    hace 2 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    Job OverviewPerform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.Essential Functions Perform site monitoring visits (selection, initiation, monitoring and closeout visits) in accordance with...

  • Sr. Cra 1

    hace 4 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    **Job Overview** Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. **Essential Functions** - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in...

  • Senior Cra

    hace 2 semanas

    Buenos Aires, Argentina ICON plc A tiempo completo

    **Sr CRA - Home-based role** ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help...

  • Sr Cra

    hace 2 semanas

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    Monitors investigator sites with a risk-based monitoring approach, applies rootcause analysis (RCA), critical thinking and problem-solving skills to identify siteprocesses failure and corrective/preventive actions to bring the site intocompliance and decrease risks. Ensures data accuracy through SDR, SDV andCRF review as applicable through on-site and remote...

  • Sr CRA

    hace 3 meses

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    Job Description Monitors investigator sites with a risk-based monitoring approach, applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable...

  • Fsp Sr Cra

    hace 3 semanas

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Sr Cra

    hace 4 semanas

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams. Our global...

  • Sr CRA

    hace 3 días

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    Work ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve...

  • Sr Cra

    hace 3 meses

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    Monitors investigator sites with a risk-based monitoring approach, applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and...