Cra 1
hace 7 meses
Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
**Qualifications**:
- Bachelor's Degree Degree in scientific discipline or health care preferred. Req
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Some organizations require completion of CRA training program or prior monitoring experience.
- Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at
-
Sr Cra
hace 6 meses
Santiago de Chile Fortrea A tiempo completoAs 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 I
hace 6 meses
Santiago de Chile Fortrea A tiempo completoSite monitoring and site management responsibility for clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the implementation of project plans, as assigned. Essential Job Duties: 1) Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical...
-
Cra Ii
hace 5 meses
Santiago de Chile Fortrea A tiempo completoAs 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...
-
Cfsp Sr Cra 1
hace 5 meses
Santiago de Chile Novasyte A tiempo completoJob Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...
-
Cra (Level Ii)
hace 6 meses
Santiago de Chile Thermo Fisher Scientific A tiempo completoPPD’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 6 meses
Santiago de Chile Thermo Fisher Scientific A tiempo completoPPD’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 3 meses
Santiago de Chile Thermo Fisher Scientific A tiempo completo**Work Schedule** Other **Environmental Conditions** Office At 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...
-
Ihcra
hace 5 meses
Santiago de Chile ICON plc A tiempo completoAs In-house CRA (IHCRA), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence. The In-house CRA (IHCRA) 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...
-
Presupuestos de instalación para alarma
hace 4 meses
Rancagua (Región de O'Higgins), Chile Cronoshare.cl A tiempo completoNecesito un servicio de Instalación de Alarmas con las siguientes características:Tipo de servicio solicitado InstalaciónTipo de sistema de vigilancia Alarma¿Cuántas cámaras o detectores de movimiento quieres instalar? De 1 a 4 cámaras¿Qué tipo de alarma quieres instalar? Sistema de alarma conectado a la central receptora de...
-
Arica (Región de Arica y Parinacota), Chile Cronoshare.cl A tiempo completoNecesito un servicio de Instalación de Alarmas con las siguientes características:Tipo de servicio solicitado InstalaciónTipo de sistema de vigilancia Sistema de videovigilancia y cctv¿Cuántas cámaras o detectores de movimiento quieres instalar? De 1 a 4 cámaras¿Qué tipo de alarma quieres instalar? Sistema de alarma conectado...
-
Viña del Mar (Región de Valparaíso), Chile Cronoshare.cl A tiempo completoNecesito un servicio de Instalación de Alarmas con las siguientes características: Tipo de servicio solicitado Instalación Tipo de sistema de vigilancia Alarma, sistema de videovigilancia y cctv, control de accesos ¿Cuántas cámaras o detectores de movimiento quieres instalar? De 1 a 4 cámaras ¿Qué tipo de alarma quieres instalar?...
-
Jefe de Utp para Escuela Básica. Reemplazo 44 Horas
hace 3 meses
Santiago de Chile Corporación Municipal de Renca A tiempo completoCorporación Municipal de Renca requiere contratar **Jefe/a Técnico Pedagógica** debe organizar, guiar y evaluar los procesos de enseñanza - aprendizaje y la gestión pedagógica del centro educativo, de acuerdo a los objetivos curriculares establecidos por la normativa educacional vigente, el Proyecto Educativo Comunal y el Proyecto Educativo...
-
Country Therapeutic Area Head
hace 5 meses
Santiago de Chile MSD A tiempo completo**Job Description**: This **TA Head** will be based in Chile but will also have oversight of Perú, with a 1 week a month travelling scheme to Lima. This person will be key to further develop the country capabilities in clinical research. Under the oversight of the countries CRD these person will be responsible for the end to end performance of clinical...
-
Clinical Research Associate
hace 5 meses
Santiago de Chile MSD A tiempo completoOur 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...
-
Clinical Research Associate
hace 2 meses
Santiago de Chile MSD A tiempo completoOur 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...
