CRA (Level II)

hace 2 meses

Santiago, Chile 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 remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.  Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.  Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.  Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions ( Clinical Trial Management System).  Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.

 Responds to company, client and applicable regulatory requirements/audits/inspections.  Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.  Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.  Contributes to other project work and initiatives for process improvement, as required

  • Cra Ii

    hace 4 semanas

    Santiago de Chile ICON plc A tiempo completo

    **Experienced CRA - Santiago, Chile, 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...

  • Cra Ii

    hace 3 semanas

    Santiago, Metropolitana, Chile ICON plc A tiempo completo

    Experienced CRA - Santiago, Chile, home-based roleICON 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...

  • Cra Ii

    hace 2 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...

  • Cra (Level Ii)

    hace 3 semanas

    Santiago, Metropolitana, Chile 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...

  • Cra (Level Ii)

    hace 4 semanas

    Santiago de Chile 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...

  • Cra (Level Ii)

    hace 1 mes

    Santiago de Chile 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...

  • Cra Ii

    hace 1 semana

    Santiago de Chile ICON plc A tiempo completo

    As a CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. A CRA is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity. You will be partnering with one of our global...

  • Cra Ii

    hace 3 semanas

    Santiago de Chile ICON plc A tiempo completo

    ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development...

  • Cra Ii

    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...

  • Cra Ii

    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...

  • Cra Ii

    hace 3 semanas

    Santiago, Metropolitana, Chile ICON A tiempo completo

    As a CRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.A CRA is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity.You will be partnering with one of our global...

  • Cra Ii

    hace 3 semanas

    Santiago de Chile ICON A tiempo completo

    As Clinical Research Associate (CRA), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence. You will be dedicated resource to one of our clients, be embedded in their working environment, systems and processes. You will be engaged in a wide range of interesting and challenging...

  • Cra Ii

    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 fulfil 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 organisation: Accountability & Delivery,...

  • Cra (Level Ii)

    hace 1 semana

    Santiago, Chile 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...

  • CRA (Level II)

    hace 5 días

    Santiago, Chile 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...

  • Cra (Level Ii)

    hace 1 semana

    Santiago, Chile 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...

  • Cra Ii

    hace 3 semanas

    Santiago, Metropolitana, Chile Fortrea A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Cra Ii

    hace 2 semanas

    Santiago de Chile Fortrea A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Cra Ii

    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 fulfil 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 organisation: Accountability & Delivery,...

  • Cra Manager

    hace 3 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. Our ability to excel depends on the integrity, knowledge, imagination, skill,...