Associate Cra
hace 1 semana
With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Participates & provides inputs on site selection and validation activities.
- Performs remote and on-site monitoring & oversight activities using various tools to ensure: o Data generated at site are complete, accurate and unbiased o Subjects’ right, safety and well-being are protected
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
- Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites
- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
- Supports audit/inspection activities as needed.
- Performs co-monitoring where appropriate.
**Secondary** Language(s) Job Description**:
Competency Expectations:
- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices
- Developing skills in Site Management including management of site performance and patient recruitment
- Developing level of monitoring skill and independent professional judgment.
- Works with high quality and compliance mindset.
- Capable of managing complex issues, solution-oriented approach.
- Ability to perform root cause analysis and implement preventative and corrective action.
Behavioural Competency Expectations:
- Effective time management, organizational and interpersonal skills, conflict management
- Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.
- High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to Customer focus.
- Positive mindset, growth mindset, capable of working independently and being self driven.
- Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.
B.A./B.S. required with strong emphasis in science and/or biology.
Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Hybrid
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Job Posting End Date**:
11/13/2024
**Requisition ID**:R320624
-
Cra I, Cra Ii or Senior Cra, Single-sponsor
hace 4 días
Santiago de Chile ICON Plc A tiempo completoCRA I, CRA II, Sr. CRA - Chile, Santiago 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 We are currently seeking a Clinical Research Associate...
-
Associate CRA
hace 3 días
Santiago, Chile MSD A tiempo completoJob Description With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site...
-
Cra Ii
hace 3 semanas
Santiago de Chile Icon plc A tiempo completoCRA II or Senior CRA, Santiago, Chile 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 We are currently seeking a Clinical Research Associate II...
-
Cra Ii
hace 4 días
Santiago de Chile ICON Plc A tiempo completoCRA II or Senior CRA, Santiago, Chile 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 We are currently seeking a Clinical Research Associate II...
-
CRA I, CRA II or Senior CRA, Single-Sponsor
hace 2 días
Santiago, Chile ICON Plc A tiempo completoCRA I, CRA II, Sr. CRA - Chile, Santiago 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. We are currently seeking a Clinical Research...
-
Senior Cra
hace 4 días
Santiago de Chile ICON Plc A tiempo completoSenior CRA - Argentina, Buenos Aires 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 We are currently seeking a Senior Clinical Research...
-
CRA I, CRA II or Senior CRA, Single-Sponsor
hace 3 días
Santiago, Chile ICON plc A tiempo completoCRA I, CRA II, Sr. CRA - Chile, Santiago 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 We are currently seeking a Clinical Research...
-
Clinical Research Associate
hace 2 meses
Santiago de Chile AstraZeneca A tiempo completoEs responsable por la entrega de los estudios en los sitios asignados y participa en los equipos de estudio locales. El CRA trabaja en estrecha colaboración con otros CRA y el Equipo de estudio local / Gerente de estudio local para garantizar que los compromisos del estudio se logren de manera oportuna y eficiente. El CRA actúa como el contacto principal...
-
Cra Ii
hace 5 meses
Santiago de Chile ICON plc A tiempo completo**Experienced CRA - Santiago, Chile, 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...
-
Senior Cra or Cra Ii
hace 4 días
Santiago de Chile ICON Plc A tiempo completoCRA II or Senior CRA - Santiago, Chile - 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 **What you will be doing**: As a Clinical...
-
Cra Ii
hace 5 meses
Santiago de Chile ICON A tiempo completoAs Clinical Research Associate (CRA), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence. You will be dedicated resource to one of our clients, be embedded in their working environment, systems and processes. You will be engaged in a wide range of interesting and challenging...
-
Cra Ii
hace 2 meses
Santiago de Chile Icon plc A tiempo completoCRA II - Santiago, Chile - 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 At ICON, it’s our people that set us apart. Our diverse teams...
-
Senior Cra
hace 2 meses
Santiago de Chile Icon plc A tiempo completoSenior CRA - Santiago, Chile - 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 At ICON, it’s our people that set us apart. Our diverse...
-
Cra Ii
hace 5 meses
Santiago de Chile ICON plc A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development...
-
Senior Cra
hace 5 meses
Santiago de Chile ICON plc A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development...
-
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...
-
Cra Ii
hace 5 meses
Santiago de Chile ICON plc A tiempo completoAt 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,...
-
Senior CRA
hace 2 días
Santiago, Chile ICON Plc A tiempo completoSenior CRA - Argentina, Buenos Aires 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. We are currently seeking a Senior Clinical Research...
-
Senior CRA
hace 3 días
Santiago, Chile ICON plc A tiempo completoSenior CRA - Santiago, Chile - 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. At ICON, it’s our people that set us apart. Our...
-
Senior Cra
hace 5 meses
Santiago de Chile ICON plc A tiempo completoAt 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,...
