Cra (Level Ii)
3 semanas atrás
Essential Functions
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 (e.g. Clinical Trial Management System).
Facilitates effective communication between investigative sites, the client
company
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
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Cra Ii
3 semanas atrás
Sao Paulo, Brasil ICON plc Tempo inteiro**CRA II** **JR115389** **Site: São Paulo, Brazil** 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...
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Cra Ii
Há 5 dias
Sao Paulo, Brasil ICON plc Tempo inteiroAt 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,...
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Cra Ii
3 semanas atrás
Sao Paulo, Brasil ICON plc Tempo inteiroAt 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,...
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Cra (Level Ii)
2 meses atrás
Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteirodata 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...
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Cra (Level Ii)
Há 6 dias
Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro**Essential Functions** - 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...
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Cra (Level Ii)
1 semana atrás
Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteirodata 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...
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Senior Cra
Há 5 dias
Sao Paulo, Brasil ICON plc Tempo inteiroAt 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,...
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Senior Cra
Há 5 dias
Sao Paulo, Brasil ICON plc Tempo inteiroAt 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,...
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CRA (Level II)
2 semanas atrás
São Paulo, Brasil Thermo Fisher Scientific Tempo inteiroPerforms and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments ( FSO, FSP, Government, etc.). Acts as a site processes...
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CRA (Level II)
2 meses atrás
São Paulo, Brasil Thermo Fisher Scientific Tempo inteiroPerforms and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments ( FSO, FSP, Government, etc.). Acts as a site processes...
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CRA (Level II)
2 meses atrás
São Paulo, Brasil Thermo Fisher Scientific Tempo inteiroPerforms and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments ( FSO, FSP, Government, etc.). Acts as a site processes...
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CRA (Level II)
3 semanas atrás
São Paulo, Brasil Thermo Fisher Scientific Tempo inteiroPerforms and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments ( FSO, FSP, Government, etc.). Acts as a site processes...
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CRA (Level II)
4 semanas atrás
São Paulo, Brasil Thermo Fisher Scientific Tempo inteiroPerforms and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments ( FSO, FSP, Government, etc.). Acts as a site processes...
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CRA (Level II)
3 semanas atrás
São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiroJob DescriptionPerforms and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a...
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CRA (Level II)
1 semana atrás
São Paulo, Brasil Thermo Fisher Scientific Tempo inteiroPerforms and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments ( FSO, FSP, Government, etc.). Acts as a site processes...
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CRA (Level II)
3 semanas atrás
São Paulo, Brasil Thermo Fisher Scientific Tempo inteiroJob DescriptionPerforms and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a...
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Sr Cra
3 semanas atrás
Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiroEssential Functions 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...
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Cra - All Levels
Há 4 dias
Sao Paulo, Brasil Fortrea Tempo inteiroAs 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...
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Lead CRA
1 semana atrás
São Paulo, Brasil PSI CRO Tempo inteiroJob DescriptionIn the role of Lead Monitor, you will manage local Monitors, supervising clinical monitoring and site management activities to verify the protection of trial subjects’ rights, safety and well-being, data quality and study compliance on a country/regional level.Only CVs in English will be considered.You will:Facilitate regional projects as...
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Lead CRA
3 semanas atrás
São Paulo, Brasil PSI CRO Tempo inteiroJob DescriptionIn the role of Lead Monitor, you will manage local Monitors, supervising clinical monitoring and site management activities to verify the protection of trial subjects’ rights, safety and well-being, data quality and study compliance on a country/regional level.Only CVs in English will be considered.You will:Facilitate regional projects as...