Sr Cra´s
hace 2 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 Good Clinical Practice.
- 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) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP 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
- Requires at least 2 years of year of on-site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Good 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
Tenemos otros empleos actuales relacionados con este campo que puede encontrar a continuación
-
Cra Ii or Sr Cra Oncology
hace 2 meses
Edo. de México Syneos Health Clinical A tiempo completo**Description** **CRA II or Sr CRA oncology & on site experience Home Based Mexico** **CDMX/Aguascalientes/Oaxaca/Guadalajara - availability to travel required** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting...
-
Sr Cra I
hace 3 semanas
Edo. de México Syneos Health Clinical A tiempo completo**Description** **Senior Clinical Research Associate I** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to...
-
Sr Cra I
hace 2 meses
Edo. de México Syneos Health Clinical A tiempo completo**Description** **Senior Clinical Research Associate I** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to...
-
Cra I
hace 4 semanas
Ciudad de México 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 I
hace 2 semanas
Ciudad de México Thermo Fisher Scientific A tiempo completoOur 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, who powers our PPD® clinical research portfolio, are part of our leading global...
-
Cra Ii or Sr Cra Assigned to Client Cdmx/gdl/mty
hace 2 meses
Edo. de México Syneos Health Clinical A tiempo completo**Description** **CRA II or SR CRA assigned to client CDMX/GDL/MTY** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide...
-
Sr Cra
hace 3 semanas
Ciudad de México 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...
-
Sr Program Manager, S&op, S&op
hace 2 semanas
Ciudad de México Servicios Comerciales Amazon M A tiempo completoBachelor's degree in Supply Chain, Engineering, Statistics, Computer Science, or related discipline. - 5+ years' experience as planning demand and/or Capacity on a Supply Chain related field. - End to end knowledge of the standard S&OP process. - Experience with databases in a business environment with large-scale, complex datasets and data visualization. -...
-
Sr. Program Manager, S&op
hace 3 días
Ciudad de México Servicios Comerciales Amazon Mexico S. de R.L. de C.V. A tiempo completoBachelor's degree - 5+ years of supply chain experience - 5+ years of managing stakeholders in cross-functional project experience - 5+ years of program or project management experience - Knowledge of Excel at an intermediate level (e.g., pivot tables & charts, multiple criteria lookups, nested logical/IF formulas, data cleansing, array formulas, etc.) - 5+...
-
Sr Clinical Research Asociate
hace 3 semanas
Ciudad de México MSD A tiempo completoThe 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, MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary...
-
Sr Clinical Research Asociate
hace 3 semanas
Ciudad de México MSD A tiempo completoThe 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, MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary...
-
Sr Cra I
hace 2 meses
Edo. de México Syneos Health Clinical A tiempo completo**Description** **Clinical Research Associate I** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help...
-
Sr. Program Manager, S&OP
hace 3 días
Ciudad de México, Ciudad de México Servicios Comerciales Amazon Mexico S. de R.L. de C.V. A tiempo completoAt Amazon, we strive to be Earth's most customer-centric company where people can find and discover anything they want to buy online. The Sales and Operations Planning (S&OP) team is looking for a leader in the space of Supply Chain, Capacity Planning and Forecasting. The primary role of the Sr Program Manager is to address business challenges and create...
-
Sr Clinical Research Associate
hace 3 semanas
Ciudad de México MSD A tiempo completoThe role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as...
-
Sr Clinical Research Associate
hace 3 semanas
Ciudad de México MSD A tiempo completoThe role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as...
-
Sr Cra I
hace 2 semanas
Edo. de México Syneos Health Clinical A tiempo completo**Description** **Senior Clinical Research Associate I** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to...
-
Sr. Program Manager, S&OP
hace 3 días
Ciudad de México, Ciudad de México Amazon A tiempo completoAt Amazon, we strive to be Earth's most customer-centric company where people can find and discover anything they want to buy online. The Sales and Operations Planning (S&OP) team is looking for a leader in the space of Supply Chain, Capacity Planning and Forecasting.The primary role of the Sr Program Manager is to address business challenges and create...
-
Sr Cra 1
hace 5 días
Ciudad de México 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...
-
Clinical Research Assistant
hace 3 días
Ciudad de México, Ciudad de México COVANCE MEXICO SERVICES S DE RL DE CV A tiempo completoCovance is growing again in Mexico This is an exciting opportunity to join one of the fastest growing parts of our business • Act as contact for project team and study sites.• Perform CRF review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned...
-
Operations Sr. Specialist
hace 3 semanas
Ciudad de México MSD A tiempo completo**Job Description**: The Operations Sr. Specialist will collaborate with the Operations managers in the management of medical affairs events, management of scientific content for medcial interactions and expense control of the area. **Search Firm Representatives Please Read Carefully** **Employee Status**: Temporary (Fixed Term) **Relocation**: **VISA...
