Sr Cra
hace 5 días
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
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 pplicableProvides 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, CTMS). Performs QC check of reports generated from CTMS system where required.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. Ensures 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.Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).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 other project work and initiatives for process improvement, as required
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Sr Cra
hace 4 días
Santiago de Chile MSD A tiempo completoCRA with a minimum of 4 years acting as primary site contact and site manager (monitoring) in a bio/pharma/CRO. Fluent in Local Language and English (verbal and written) and excellent communication skills. **Responsibilities include, but are not limited to**: - Develops strong site relationships and ensures continuity of site relationships through all...
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Sr Cra
hace 4 días
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...
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Senior Cra
hace 3 días
Santiago de Chile ICON Plc A tiempo completoSr. CRA Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development The role: As a CRA you will work independently and actively handle all necessary...
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Senior Cra
hace 7 días
Santiago de Chile Icon plc A tiempo completoSr CRA - 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 of all that we do, we help to...
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Senior Cra
hace 1 semana
Santiago de Chile Icon plc A tiempo completoSr CRA - 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 of all that we do, we help to...
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Sr Cra
hace 4 días
Santiago de Chile Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office 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...
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Senior CRA
hace 4 semanas
Santiago, Metropolitana, Chile ICON A tiempo completoSr. CRA Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. The role: As a CRA you will work independently and actively handle all...
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Senior Cra
hace 1 día
Santiago de Chile Icon plc A tiempo completo**Sr CRA - 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 of all that we do, we help...
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Sr Cra I
hace 2 semanas
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...
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Senior Clinical Research Associate
hace 1 semana
Santiago de Chile Parexel A tiempo completo**We are looking for passionate professionals with sufficient experience to become Sr CRA, to work in Chile supporting onsite monitoring in Chile, Argentina, and some remotely.** **Your time here** At Parexel, the CRA role offers the opportunity to go beyond the role of a typical clinical monitor. CRA’s are accountable for using their expertise to build...
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Sr Clinical Trial Coordinator
hace 3 días
Santiago de Chile MSD A tiempo completo**Job Description**: Bajo la supervisión del gerente de línea, esta personal es responsable de las actividades financieras integrales de estudio y sitio. El rol es fundamental para cumplir con las fechas planificadas de Start-up del sitio, la negociaciones del contrato. La función colaborará a nível local estrechamente con COM, CRM y CRA. **Colaborará...
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Sr Clinical Research Associate
hace 1 semana
Santiago de Chile MSD A tiempo completo**Job Description**: 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 policies and procedures, quality standards and adverse event reporting requirements internally and...
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Sr. Clinical Research Associate
hace 3 semanas
Chile Alimentiv Inc A tiempo completoManage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale. In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document...
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Clinical Research Associate
hace 2 semanas
Santiago, Metropolitana, Chile ICON Strategic Solutions A tiempo completoClinical Research Associate (Multiple Openings-level I, II and Senior) We have multiple Sponsor dedicated opportunities for CRA I, CRA II and Sr. CRA's. 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 part of an innovative and...