Senior Clinical Research Associate

hace 4 semanas

Santiago de Chile ICON plc A tiempo completo

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership, and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touchpoint. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and friendliest people in the sector, and you’ll be helping shape an industry.

**What will you be doing?**

The Remote Clinical Research Associate is responsible for managing, implementing, and monitoring clinical studies, with support, in a team setting according to ICON SOPs, SSPs, and all applicable rules and regulations. The responsibilities of this position include but are not limited to identifying, training/initiating, and closing out study sites; conducting remote site monitoring visits and/or targeted on-site visits as needed, conducting remote site management activities, managing study sites and the required protocols, amendments and/or deviations, assuring that data is reported accurately and timelines are maintained.

**The Role Responsibilities**:

- Recognize, exemplify, and adhere to ICON's values which center around our commitment to People, Clients, and Performance.
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business, and meeting client needs.
- Ability to work on study teams that are often virtual, multi-cultural, and multi-disciplinary.
- Serves as the primary contact for sites and investigators participating in studies.
- Acts as a resource for internal study teams and other ICON departments

Maintains, reviews, and ensures adequacy of information and data contained in site management reports, tracking systems (CTMS or others), and other site management documents.
- Conducts and completes remote site management activities, with support as needed, according to applicable SOPs and the Site Management Plan.
- Participates in QA audits as needed.
- Regularly attends and contributes to project-specific and departmental meetings

Ability and willingness to travel as needed (drive and fly) - approximately 25% of the time.
- Reviews drug storage and drug accountability procedures (as applicable), in accordance with applicable SOPs.
- Maintains and archives study documentation and correspondence, as needed.
- Assists with site contracting process, as needed.
- Assists with timely preparation and submission of regulatory documents for IRB/IEC submissions according to local requirements, with support, as needed.
- With support, demonstrates the ability to manage site assignments and workload

Maintains Sponsor and patient confidentiality.
- Actively participates in regular meetings with Project Managers or delegates, and/or RS

**LEAD**
- Assists in the development of site and patient enrolment strategies with the project team; works to motivate sites to meet enrolment timelines.
- Developing knowledge of and compliance with local regulatory requirements

Compliant and current with departmental and corporate policies and procedures.

**COMMUNICATION**
- Excellent written and oral skills while showing cultural awareness and understanding; strong presentation skills, and proactive interaction with the study team and site staff.
- Demonstrates ability to provide and receive constructive feedback; appreciates team goals, respects other's point of view, and seeks advice when appropriate.

**BUSINESS DEVELOPMENT**
- supports the formation of relationships with internal and external customers

May attend bid defense presentations, as needed.
- Supports internal and external capabilities presentations.

**TEAMWORK**
- Works in collaboration with internal and external colleagues to meet project objectives, timelines, and budgets.
- Follows departmental policies and procedures.

Takes responsibility for project tasks and sees these tasks through to successful completion, with support.
- Completes special projects and miscellaneous assignments as needed to meet project and/or department objectives.
- Maintains professional interpersonal relationships with team, sites, and Sponsor.

**PERSONAL/PROFESSIONAL DEVELOPMENT**
- Increases knowledge of therapeutic areas, GCP, and any applicable local regulatory requirements.
- Seeks opportunities to demonstrate leadership and enhance own professional growth.
- Actively participates in Lunch and Learns, Journal Clubs, or other internal company training se

  • Senior Clinical Research Associate

    hace 3 semanas

    Santiago de Chile 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 Research Associate

    hace 3 semanas

    Santiago de Chile CTI Clinical Trial Services, Inc A tiempo completo

    **Senior Clinical Research Associate** **(Level dependent on experience)** **Please submit your CV in English for Quickest Review Process!** Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can...

  • Senior Clinical Research Associate

    hace 6 días

    Santiago de Chile CTI Clinical Trial Services, Inc A tiempo completo

    **Senior Clinical Research Associate** (Level dependent on experience)** **Please submit your CV in English for Quickest Review Process!** Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can...

  • Clinical Research Associate

    hace 3 semanas

    Santiago de Chile MSD A tiempo completo

    **Job Description**: The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and...

  • Clinical Research Associate

    hace 3 semanas

    Santiago de Chile 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...

  • Sr Clinical Research Associate

    hace 4 semanas

    Santiago de Chile MSD A tiempo completo

    **Job Description**: The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and...

  • Sr Clinical Research Associate

    hace 4 semanas

    Santiago de Chile MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary...

  • Clinical Research Associate

    hace 2 meses

    Santiago de Chile MSD A tiempo completo

    **Job Description**: The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally....

  • Clinical Research Associate

    hace 2 semanas

    Santiago, Metropolitana, Chile MSD A tiempo completo

    Job Description:The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally....

  • Clinical Associate

    hace 3 semanas

    Santiago de Chile 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...

  • Senior Clinical Research Associate I

    hace 7 días

    Santiago de Chile 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...

  • Clinical Research Associate

    hace 4 semanas

    Santiago de Chile MSD A tiempo completo

    **Job Description**: Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company "“ one that is ready to help create a healthier future for all of us. Responsibilities include, but not limited to: - Acts as primary site...

  • Clinical Research Associate

    hace 2 semanas

    Santiago, Metropolitana, Chile PSI CRO A tiempo completo

    Company DescriptionWe 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...

  • Clinical Trial Manager

    hace 2 días

    Chile Worldwide Clinical Trials A tiempo completo

    Requisition Number8052Employment 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 quality and excellence. ...

  • Clinical Research Associate

    hace 7 días

    Santiago de Chile MSD A tiempo completo

    Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and...

  • Senior Clinical Research Associate

    hace 3 semanas

    Santiago de Chile AbbVie A tiempo completo

    **Company Description** To enable AbbVie’ s emergence as a world class R&D organization, the position plays a key role in ensuring successful protocol level execution of CSM deliverables involving start-up, execution, and close-out of studies. **Responsibilities**: - For assigned sites/study(s), ensure successful protocol level execution of CSM...

  • Senior Clinical Research Associate

    hace 2 semanas

    Santiago, Metropolitana, Chile AbbVie A tiempo completo

    Company DescriptionTo enable AbbVie' s emergence as a world class R&D organization, the position plays a key role in ensuring successful protocol level execution of CSM deliverables involving start-up, execution, and close-out of studies.Responsibilities: For assigned sites/study(s), ensure successful protocol level execution of CSM deliverables involving...

  • Senior Clinical Research Associate

    hace 2 semanas

    Santiago, Metropolitana, Chile ICON plc A tiempo completo

    At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration,...

  • Senior Clinical Research Associate

    hace 2 semanas

    Santiago, Metropolitana, Chile AbbVie A tiempo completo

    Job Description To enable AbbVie' s emergence as a world class R&D organization, the position plays a key role in ensuring successful protocol level execution of CSM deliverables involving start-up, execution, and close-out of studies.Responsibilities:For assigned sites/study(s), ensure successful protocol level execution of CSM deliverables involving...

  • Senior Clinical Research Associate

    hace 3 semanas

    Santiago, Chile AbbVie A tiempo completo

    Job Description To enable AbbVie’ s emergence as a world class R&D organization, the position plays a key role in ensuring successful protocol level execution of CSM deliverables involving start-up, execution, and close-out of studies.Responsibilities:For assigned sites/study(s), ensure successful protocol level execution of CSM deliverables involving...