Senior Clinical Research Associate, Argentina

hace 4 semanas

Buenos Aires, Argentina IQVIA A tiempo completo

**BASIC FUNCTIONS**:
Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. The Senior CRA may also serve in the Lead CRA role.

**ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES**:

- Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.
- Collaborates with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents
- Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
- Trains site staff on the EDC system and verifies site computer system.
- Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.
- Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.
- Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.
- Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.
- May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.
- Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
- Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
- Assists with, and attends, Investigator Meetings for assigned studies.
- Authorized to request site audits due to data integrity concerns.
- Attends study-related, company, departmental, and external meetings, as required.
- Ensures internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.
- Ensures all study deliverables are completed per IQVIA Biotech and study timelines
- Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.
- Serves as mentor for junior CRAs and those new to the company and/or study.
- Performs other duties, as requested.

**LEAD CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES**:
The Lead Clinical Research Associate **may** **perform any of the following tasks:

- Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.
- Collaborate with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents
- Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
- Assists with, and attends, Investigator Meetings for assigned studies.
- Train site staff on the EDC system and verify site computer system.
- Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISS.
- Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Perf

  • Clinical Research Associate

    hace 2 semanas

    Buenos Aires, Argentina Worldwide Clinical Trials A tiempo completo

    Requisition Number6764Employment Type:RegularWho we areWe'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 quality and excellence.What Clinical...

  • Clinical Research Associate

    hace 7 días

    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...

  • Senior Clinical Associate

    hace 3 semanas

    Buenos Aires, Argentina ICON A tiempo completo

    **Senior Clinical Associate - Buenos Aires, Argentina** 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...

  • Senior Clinical Associate

    hace 3 semanas

    Buenos Aires, Argentina ICON plc A tiempo completo

    **Senior Clinical Associate - Buenos Aires, Argentina** 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...

  • Senior Clinical Associate

    hace 4 días

    Buenos Aires, Argentina Icon plc A tiempo completo

    Senior Clinical Associate - Buenos Aires, Argentina 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...

  • Senior Clinical Research Associate

    hace 2 semanas

    Buenos Aires, Argentina PSI A tiempo completo

    Job DescriptionWe are seeking a temporary freelance Clinical Research Associate to be the main point of contact with project stakeholders, ensuring project timelines, targets, and standards are met across various therapeutic areas. Only resumes in English will be accepted for this remote position in Argentina.You will:Conduct and report onsite monitoring...

  • Senior Clinical Research Associate

    hace 2 semanas

    Buenos Aires, Argentina MPC Moving Picture Company A tiempo completo

    Company DescriptionWe are a company that values its employees, customers, partners, and the quality of our work. Established in 1995, we are a dynamic global organization with over 2,500 dedicated individuals who are passionate about making a difference in the field of medical science by bringing life-changing medications to those in need.Job DescriptionWe...

  • Experienced Clinical Research Associate

    hace 4 semanas

    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...

  • Senior Clinical Research Associate

    hace 1 mes

    Buenos Aires, Argentina PSI CRO A tiempo completo

    Job DescriptionWe are looking for a temporary freelance Clinical Research Associate to work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. Only CVs in English will be consideredHome-based position in ArgentinaYou will:Conduct and...

  • Senior Clinical Research Associate

    hace 1 mes

    Buenos Aires, Argentina PSI A tiempo completo

    Job Description We are looking for a temporary freelance Clinical Research Associate to work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications.  Only CVs in English will be considered Home-based position in Argentina You will: ...

  • Clinical Research Associate

    hace 2 semanas

    Buenos Aires, Argentina Novo Nordisk A tiempo completo

    Clinical Research Associate (4 positions)Category:Clinical DevelopmentLocation:Ciudad Autónoma de Buenos Aire, Ciudad Autónoma de Buenos Aires, AR-The Position As Clinical Research Associate you will be the primary point of contact between site staff and Novo Nordisk. You will act as ambassador for the company and contributes to making Novo Nordisk the...

  • Experienced Clinical Research Associate

    hace 2 semanas

    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...

  • Senior Clinical Research Associate, Argentina

    hace 2 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    BASIC FUNCTIONS:Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works...

  • Senior Clinical Research Associate, Argentina, Biotech

    hace 2 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    IQVIA Biotech is hiring in Argentina Join our team as a Senior Clinical Research Associate. The ideal candidate will have varied therapeutic experience and be willing to working across multiple therapeutics including: Oncology, Cardiovascular, Internal Medicine, & ophthalmology. This role will be home-based in Buenos Aires, Argentina. ​ BASIC FUNCTIONS: ...

  • Senior Clinical Research Associate, Argentina, Biotech

    hace 4 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    IQVIA Biotech is hiring in Argentina Join our team as a Senior Clinical Research Associate. The ideal candidate will have varied therapeutic experience and be willing to working across multiple therapeutics including: Oncology, Cardiovascular, Internal Medicine, & ophthalmology. This role will be home-based in Buenos Aires, Argentina. BASIC FUNCTIONS: ...

  • Clinical Research Associate Ii

    hace 4 semanas

    Buenos Aires, Argentina PSI CRO A tiempo completo

    Company Description We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those...

  • Senior Clinical Associate

    hace 1 mes

    Buenos Aires, Argentina ICON plc A tiempo completo

    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 to accelerate the development...

  • Experienced Clinical Research Associate

    hace 2 semanas

    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 Argentina, and be...

  • Clinical Research Associate

    hace 4 semanas

    Buenos Aires, Argentina PSI CRO A tiempo completo

    Company Description We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those...

  • Experienced Clinical Research Associate

    hace 2 semanas

    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 bringing...