Cra (Level Ii)
Há 1 mês
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 follow-up on findings as applicable. - Participates in investigator meetings as necessary. May help to identify 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 team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System). - Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections. - Maintains and 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.
Education and Experience: Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered. Valid driver's license where applicable.
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: - Basic medical/therapeutic area knowledge and understanding of medical terminology - Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and - procedural documents - Good oral and written communication skills, with the ability to communicate effectively with medical personnel - Good interpersonal skills - Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues - Good organizational and time management skills - Ability to remain flexible and adaptable in a wide range of scenarios - Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving - Ability to manage Risk Based Monitoring concepts and processes - Ability to work in a team or independently as required - Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software - Good English language and grammar skills Working Environment: PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activitie
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Cra Ii
Há 3 dias
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 4 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)
Há 7 dias
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 (Level II)
Há 1 mês
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)
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)
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)
Há 1 mês
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)
Há 7 dias
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)
Há 7 dias
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
Há 7 dias
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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Lead CRA
Há 5 dias
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.
Há 1 mês
São Paulo, Brasil PSI Tempo inteiroJob Description In 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...
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Sr CRA
1 semana atrás
São 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...
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Sr CRA
1 semana atrás
São 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...
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CRA - all levels
Há 1 mês
São 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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Safety Technician Level Ii
1 semana atrás
Sao Paulo, Brasil Cummins Inc. Tempo inteiro**Safety Technician Level II** **Description** Provides support on health and safety to production and site personnel under the guidance of the site HSE leader. Assists in the analysis, review and sustainability of Health & Safety Management Systems. Health, Safety and Environmental (HSE) Plan Maintains skills and knowledge required to perform job...
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Consultor Especialista Ii
Há 1 mês
Sao Paulo, Brasil NEC Corporation Tempo inteiro**Data**:23 de jun de 2023 **Localização**: Sao Paulo, BR, 05001-100 **Empresa**:NEC Corporation **Consultor Especialista II** - Experiência nas atividades de Pré-Vendas / deployment em soluções cloud de ao menos uma das principais (AWS/GCP/Oracle) e de Automação da Cisco (NSO, Sedona) em cliente de grande porte no segmento de Telecomunicações...
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Sr Cra
Há 1 mês
Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro**Summarized Purpose
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Customer Service Representative Level Ii
Há 7 dias
Sao Paulo, Brasil Thales Tempo inteiroThales people architect identity management and data protection solutions at the heart of digital security. Business and governments rely on us to bring trust to the billons of digital interactions they have with people. Our technologies and services help banks exchange funds, people cross borders, energy become smarter and much more. More than 30,000...
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Clinical Research Associate Ii
Há 1 mês
Sao Paulo, Brasil MSD Tempo inteiro**Responsibilities include, but are not limited to**: - 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 company policies and procedures, quality standards and adverse event...