Clinical Research Associate
hace 3 días
Our 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. Responsibilities include, but not limited to: - Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall 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: - Data generated at site are complete, accurate and unbiased - 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 CRM, PLM and RCPM. - Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. - Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required. - Supports and/or leads audit/inspection activities as needed. Experience Requirements: Required:"- Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO. Educational Requirements: - B.A./B.S. with strong emphasis in science and/or biology Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. **Search Firm Representatives Please Read Carefully** **Employee Status**: Regular **Relocation**: No relocation **VISA Sponsorship**: **Travel Requirements**: **Flexible Work Arrangements**: **Shift**: **Valid Driving License**: **Hazardous Material(s)**: **Requisition ID**:R262568
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Senior Clinical Research Associate
hace 7 días
Santiago de Chile PSI CRO A tiempo completoCompany Description We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those...
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Clinical Research Associate Ii
hace 6 días
Santiago de Chile PSI CRO A tiempo completoCompany Description PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. **Job Description**: As a Clinical Research Associate at PSI...
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Sr Clinical Research Associate
hace 2 semanas
Santiago de Chile 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, our policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary...
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Clinical Research Associate
hace 3 días
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, policies and procedures, quality standards and adverse event reporting requirements internally and externally....
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Clinical Site Operations Associate I
hace 3 días
, Región Metropolitana de Santiago, Chile PSI CRO A tiempo completoA global clinical research organization is seeking a professional to support clinical research projects in Santiago, Chile. The role involves managing communication between site personnel and the clinical research associates, ensuring compliance with local regulations, and managing clinical supplies. The ideal candidate holds a degree in life sciences, has...
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Senior Clinical Research Associate
hace 7 días
Santiago, Metropolitana, Chile CTI Clinical Trial Services A tiempo completoSenior Clinical Research Associate (Level dependent on experience) Please submit your CV in English for Quickest Review Process Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an...
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Clinical Research Associate
hace 1 semana
Santiago de Chile PSI CRO A tiempo completo**Company Description** We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to...
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Senior Clinical Research Associate
hace 4 días
Santiago de Chile CTI Clinical Trial Services, Inc A tiempo completo**Senior Clinical Research Associate** **(Level dependent on experience)** **Please submit your CV in English for Quickest Review Process!** Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can...
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Lead Clinical Research Associate
hace 1 día
Santiago de Chile PSI CRO A tiempo completo**Company Description** PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. - Coordinates investigator/ site feasibility and identification...
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Clinical Associate
hace 1 semana
Santiago de Chile ICON plc A tiempo completoICON 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 accelerate the development...
