- Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
- Responsible for all aspects of site management as prescribed in the project plans.
- General On-Site Monitoring Responsibilities.
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
- Monitor data for missing or implausible data.
- Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
- Ensure audit readiness at the site level.
- Travel, including air travel, may be required and is an essential function of the job.
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Basic knowledge of Regulatory Guidelines
- Basic understanding of the clinical trial process
- Fluent in local office language and in English, both written and verbal Experience (Minimum Required):
- Six (6) months experience in a related role (e.g., site management, in-house CRA, studycoordinator, research nurse, etc.)
- Basic understanding of Regulatory Guidelines
- Ability to work within a project team
- Good planning, organization, and problem-solving skills
- Good computer skills with good working knowledge of a range of computer packages
- Works efficiently and effectively in a matrix environment
- One (1) or more year's additional experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred. Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
-
Cra
há 1 semana
Thermo Fisher Scientific Sao Paulo, BrasilEssential 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 an ...
-
Senior Cra
há 1 semana
ICON plc Sao Paulo, Brasil**Senior CRA** · **JR107700** · **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 dr ...
-
Senior Cra
há 2 semanas
ICON plc Sao Paulo, BrasilAt 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 ...
-
Sr Cra
há 3 semanas
Thermo Fisher Scientific Sao Paulo, BrasilOur team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world's most challenging health concerns. Our Clinical Research team, wh ...
-
Senior Cra
há 2 semanas
ICON plc Sao Paulo, BrasilAt 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 ...
-
Sr Cra
há 2 semanas
Thermo Fisher Scientific Sao Paulo, BrasilPPD'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 u ...
-
Cra Ii
há 2 semanas
ICON plc Sao Paulo, BrasilAt 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 ...
-
Assistant Cra
há 3 dias
Thermo Fisher Scientific Sao Paulo, BrasilPerforms remote activities on assigned projects in liaison with the Remote CRA, On-Site CRA and study CTM. Provides support with regards to site preparedness, logístical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in ...
-
Cra Ii
há 4 dias
ICON plc Sao Paulo, Brasil**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 ...
-
Sr Cra
há 2 semanas
Thermo Fisher Scientific Sao Paulo, BrasilPerforms 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 mon ...
-
Sr Cra
há 1 semana
Thermo Fisher Scientific Sao Paulo, BrasilEssential 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 an ...
-
Cra (Level Ii)
há 2 semanas
Thermo Fisher Scientific Sao Paulo, Brasildata 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 wri ...
-
Cra - All Levels
há 2 semanas
Fortrea Sao Paulo, BrasilAs 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 techn ...
-
Cra Line Manager
há 5 dias
Novo Nordisk Sao Paulo, BrasilCRA Line Manager · **Category**:Clinical Development**Location**:São Paulo, São Paulo, BR- · **The Position** · As a CRA Line Manager you will oversee the monitors' staff in Brazil, comprising both Novo Nordisk and Insourced Monitors. Your primary role involves ensuring complianc ...
-
Especialista em Atendimento Receptivo Cra
há 2 semanas
Atento Brasil Sao Paulo, BrasilTemos oportunidade de emprego chegandooooo... · Essa vaga é pra você, que é apaixonado em fazer a diferença, gerar resultados, se colocar no lugar do outro e resolver problemas de forma rápida e efetiva, seu lugar é aqui · O nosso atendimento ao aluno será por voz (receptivo), co ...
-
Especialista em Atendimento Receptivo Cra
há 3 semanas
Atento Brasil Sao Paulo, BrasilTemos oportunidade de emprego chegandooooo... · Essa vaga é pra você, que é apaixonado em fazer a diferença, gerar resultados, se colocar no lugar do outro e resolver problemas de forma rápida e efetiva, seu lugar é aqui · O nosso atendimento ao aluno será por voz (receptivo), co ...
-
Especialista em Atendimento Receptivo Cra
há 3 semanas
Atento Brasil Sao Paulo, BrasilTemos oportunidade de emprego chegandooooo... · Essa vaga é pra você, que é apaixonado em fazer a diferença, gerar resultados, se colocar no lugar do outro e resolver problemas de forma rápida e efetiva, seu lugar é aqui · O nosso atendimento ao aluno será por voz (receptivo), co ...
-
Cra Line Manager Sr
há 5 dias
Novo Nordisk Sao Paulo, BrasilCRA Line Manager Sr. · **Category**:Clinical Development**Location**:São Paulo, São Paulo, BR- Seize the opportunity to shape your career with Novo Nordisk We're on the lookout for a dynamic Clinical Research Associate (CRA) Line Manager Sr. to lead our expanding Clinical Trials ...
-
Especialista em Atendimento Receptivo Cra
há 1 semana
Atento Brasil Sao Paulo, BrasilTemos oportunidade de emprego chegandooooo... · Essa vaga é pra você, que é apaixonado em fazer a diferença, gerar resultados, se colocar no lugar do outro e resolver problemas de forma rápida e efetiva, seu lugar é aqui · O nosso atendimento ao aluno será por voz (receptivo), co ...
-
Cra Ii Or Senior Cra
há 2 semanas
Icon São Paulo, BrasilAt 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 ...
Cra I - São Paulo, Brasil - Fortrea
Descrição
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 conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Job Overview:
Site monitoring and site management responsibility for clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines.
Summary of Responsibilities:
Qualifications (Minimum Required):
Valid Driver's License Preferred Qualifications Include:
