NE Outsource Resource
The role involves supporting the mission of Memorial Sloan Kettering Cancer Center in ending cancer. It likely involves outsourced resource support for clinical or research operations.
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The role involves supporting the mission of Memorial Sloan Kettering Cancer Center in ending cancer. It likely involves outsourced resource support for clinical or research operations.
The Registered Dietitian provides remote study support by assessing nutritional needs and providing personalized lifestyle counseling to patients. They are responsible for performing protocol-mandated visits, conducting nutritional education, and ensuring compliance with institutional SOPs.
The Senior CRA is responsible for monitoring investigator sites to ensure protocol and regulatory compliance while managing site documentation and data reliability. They conduct remote and on-site visits, perform root cause analysis for site failures, and maintain collaborative relationships with investigational sites.
Drive new business opportunities with pharmaceutical companies, biotechs, and CROs to increase adoption of an AI-powered regulatory platform. Manage the full sales cycle from prospecting and lead qualification to contract negotiation and closing.
Manage the day-to-day recruitment, consultation, and project management of cardiovascular clinical studies. This includes overseeing the full site activation lifecycle, managing relationships with C-suite and clinical leadership, and driving patient enrollment and retention strategies.
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Facilitate site start-up and activation by collecting and reviewing essential documents and managing communication with internal and external teams. Ensure study timelines are met and maintain the accuracy of the eTMF for assigned sites.
Provide clinical and sales support by educating healthcare providers and providing technical assistance during Structural Heart procedures. Collaborate with Territory Managers to ensure optimal patient outcomes and implement product marketing strategies.
The specialist serves as the single point of contact for site activation activities, ensuring adherence to SOPs and regulatory guidelines. They are responsible for preparing regulatory documents, tracking approvals, and maintaining internal project databases.
Lead the execution of early-stage technology initiatives and translate innovation priorities into funded product opportunities. Drive the development of product concepts across AI, sensors, and digital biomarkers while integrating cross-functional efforts across R&D, Clinical, and Commercial teams.
Lead the implementation of evidence synthesis projects to support HTA and regulatory submissions from pre-award to final delivery. Manage project teams, oversee financial and administrative requirements, and drive business development through proposals and bid defenses.
Negotiate and manage site agreements, confidentiality agreements, and letters of indemnification for clinical trials. Ensure compliance with SOPs and regulatory guidelines while collaborating with legal and project management teams.
The role involves coordinating and completing clinical trial visits both on-site and off-site while ensuring strict adherence to protocols and SOPs. Responsibilities include administering trial medication, processing samples, and accurately reporting adverse events to the project management team.
The role is responsible for managing a multifunctional team to ensure quality deliverables and compliance with customer KPIs. It involves providing line management, overseeing professional development, and managing customer escalations.
The role is responsible for overseeing site management, clinical monitoring, and regulatory compliance to ensure patient safety and data integrity. It involves coordinating with functional leaders to meet study milestones and managing the performance of CRAs and Central Monitors.
Oversee the planning, execution, and monitoring of clinical trials to ensure regulatory compliance and adherence to timelines. Coordinate with cross-functional teams and vendors to manage study budgets and ensure data integrity throughout the study lifecycle.
Provide clinical and sales support by educating customers and providing technical procedure coverage for stroke prevention products. Train interventional cardiologists and catheter lab staff on the proper use of Structural Heart technologies.
Provide clinical and sales support by training interventional cardiologists and catheter lab staff on Structural Heart products. Offer technical support during medical procedures and communicate clinical data to implement marketing strategies.
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Provide clinical and sales support by educating customers and providing technical assistance to physicians during Structural Heart procedures. Collaborate with Territory Managers to ensure optimal patient outcomes and implement product marketing strategies.
Manage and oversee contractual aspects of clinical trials, including drafting and negotiating high-value agreements like CTAs and CDAs. Ensure compliance with international regulations and provide guidance to project teams and junior specialists.
The analyst monitors clinical research records within the OnCore CTMS to ensure regulatory compliance and data integrity. They identify discrepancies, document findings, and collaborate with stakeholders to implement corrective and preventive actions.
Develop and deliver training programs and educational materials for the OnCore Clinical Trial Management System to support research staff and faculty. Serve as a subject matter expert to optimize system adoption, data quality, and operational effectiveness across the institution.
Manages and coordinates medical projects to ensure compliance and optimal performance throughout the project lifecycle. Performs safety data reviews, manages project financials, and serves as the primary point of contact for clinical project teams.
Coordinate site start-up activities and manage essential regulatory documents for clinical trials. Serve as the primary contact for investigative sites to ensure compliance with ICH/GCP guidelines and sponsor specifications.
Lead the scientific and clinical strategy for the R&D epilepsy portfolio, overseeing trial designs and regulatory alignment. Act as the primary external scientific voice and lead collaborations with academic institutions and advocacy organizations.
Assist in the coordination, administration, and documentation of clinical trials to ensure regulatory compliance. Support cross-functional teams in preparing study materials and tracking trial milestones.
Lead the development, review, and optimization of global and local informed consent forms in alignment with regulatory and sponsor requirements. Provide strategic advice to study teams and oversee translation processes and documentation for complex clinical trials.
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Lead end-to-end data management for complex global clinical trials from setup to database lock. Serve as the primary client contact while managing timelines, budgets, and mentoring junior staff.
Provide administrative and technical support for clinical trials, focusing on regulatory inspection readiness and site activation activities. Collaborate with study managers and CROs to manage study documentation, CTMS/TMF activities, and study close-out processes.
The role focuses on coordinating quality assurance and compliance delivery for clinical trials to ensure regulatory standards are met. Key duties include conducting audits, implementing QA strategies, and developing team capabilities.
Provide administrative and technical support for clinical trials, including file reviews and system maintenance of eTMF and Activate. Coordinate site activation, regulatory submissions, and collaborate with teams to ensure project goals are met on time and within budget.
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