Sr CRA (Level I) - FSP
Thermo Fisher Scientific
Thermo Fisher Scientific seeks a Senior Clinical Research Associate (Level I) to lead remote and on-site clinical trial monitoring activities. The role involves managing protocol compliance, site audits, data integrity, and regulatory documentation across multiple therapeutic sponsors globally.
Responsibilities
- Conduct on-site and remote monitoring visits to assess protocol compliance and regulatory adherence
- Perform data accuracy reviews including source document review and case report form verification
- Identify site process failures and implement corrective and preventive actions
- Prepare monitoring reports and escalate deficiencies to clinical management
- Maintain communication with investigational sites between visits and support trial closeout activities
Requirements
- Bachelor's degree in life sciences or Registered Nursing certification
- Minimum 3 years of completed on-site clinical monitoring experience
- Minimum 2 years as lead CRA on Oncology and/or Hematology trials
- Strong knowledge of ICH-GCP guidelines and applicable regulations
- Risk-based monitoring expertise and root cause analysis capabilities
- Excellent written and oral communication skills
- Critical thinking and problem-solving abilities
Vacante publicada el 16 días atrás
Empleos similares que podrían interesarleBasado en la vacante Sr CRA (Level I) - FSP en Teletrabajo
$ 152.000
...employees, the cash compensation range for this role is $152,000 – $205,000. We set standard ranges for all US roles based on function, level, and geographic location, benchmarked against similar stage growth companies. To comply with local legislation and provide greater...6.000 AR$ por año
...in backend service design defining service boundaries, contracts and data ownership, not only implementing within them ~ Business-level fluency to read, write and speak in English You'll thrive as a Senior Software Engineer, Developer Productivity, if you: Have...- ...Paid Advertising Strategist leads performance marketing strategy and execution across complex, high-value accounts, leveraging expert-level channel knowledge and advanced measurement techniques to drive results tied to broader business goals. They own campaign planning,...
- ...discipline or equivalent training and experience; and typically 12+ years of relevant experience, including enterprise- or portfolio-level technical leadership and delivery of major improvements or transformations. Preferred Education & Experience (optional): - -...
- ...best talent with the best technology. We are building that future today. ***Proficiency in spoken and written English at an advanced level is required for this role. A day in the life: - As the Paid Advertising Strategist, you are responsible for owning the execution,...
- ...deals have been properly documented, raised to the right approval levels, and resolved within set timeframes. - Handle contract... ...environment. - Strong communicator in English at a professional level (written and verbal) - Proactive, collaborative, and eager to learn...
- ...responsibilities and manage their workflow efficiently and effectively. ***Proficiency in spoken and written English at an advanced level is required for this role. Key Responsibilities: - Maintain flawless execution across all paid advertising platforms (Meta, Google,...
- ...audiences. - Follow project-specific instructions, quality standards, and evaluation criteria consistently while maintaining a high level of attention to detail. - Use digital platforms and online tools efficiently to complete assigned tasks, provide structured feedback...
- ...reporting to clients and team members through storytelling, and are constantly implementing learnings to enhance future campaign results. Sr. Creative Strategists are zealous about continuously testing various creative concepts to develop a strong understanding of how to...
- ...tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in...Trabajo remoto
- ...DevOps, QA, Product Manager). ~ Exceptional written and verbal communication skills, with an ability to engage confidently with senior-level executives. C-1 or above English language ability. ~ Proficiency with sales technology tools, including a CRM (e.g., Salesforce,...
6.000 AR$ por año
...tested, performant, and scalable code. Author, collaborate on, and evaluate design documents. Influence technical designs and team-level prioritization as well as participate in technical solutions. Collaborate with product managers and designers in an autonomous,...- ...advice to internal clients regarding national and ethical submissions Coordinate project-specific activities and serve as country-level contact for regulatory matters Maintain trial status information in tracking databases and ensure study files comply with...
- Senior Clinical Research Associate position at a global clinical research organization supporting pharmaceutical and biotech sponsors. The role involves remote and on-site monitoring of investigational sites, ensuring protocol compliance, data integrity, and regulatory...
- Thermo Fisher Scientific seeks an experienced Senior Clinical Research Associate to conduct remote and on-site monitoring of clinical trial sites across rare diseases and Alzheimer's studies. The role involves ensuring protocol compliance, managing documentation, and coordinating...
- Pfizer seeks a Clinical Research Associate to support clinical trial operations and ensure data integrity. The role involves coordinating trial activities, maintaining regulatory documentation, and managing clinical trial files in compliance with ICH-GCP standards. ...
- Thermo Fisher Scientific seeks an Assistant Clinical Research Associate to support clinical trial operations remotely from Argentina. The role involves site preparedness, remote monitoring coordination, documentation management, and logistical support across pharmaceutical...
- Thermo Fisher Scientific seeks a Medical Director or Senior Medical Director in Rheumatology to provide medical oversight of clinical trials, ensure regulatory compliance, and support safety monitoring and reporting. The role involves clinical trial management, adverse...
- Thermo Fisher Scientific seeks a Clinical Research Associate to monitor and manage clinical trial sites, ensuring compliance with protocols, ICH-GCP guidelines, and regulatory standards. The role involves coordinating with investigative sites and cross-functional teams...
- ...submissions and coordinate approval activities across clinical trial sites in Argentina. The role involves preparing and reviewing country-level submissions, providing regulatory strategy guidance, and ensuring alignment with global submission timelines. Responsibilities...
- ...activities effectively each day. - Respond to inbound patient communications through phone, SMS, and email within established service-level agreements, while proactively contacting patients to prevent delays and maintain progress. - Act as the primary point of contact for...
- ...key role in building scalable processes while staying close to the day-to-day realities of the business. The Role We’re looking for a Sr. Accounting Analyst to own prepaid expense reconciliations, lease accounting, and expense analysis across software, insurance,...
- ...emotionally. We build what makes people better and keep challenging ourselves to inspire others. We are scaling and our specialists are leveling up. Now we’re looking for talented DevOps Engineer ready to grow with us. Your impact: Manage and optimize cloud...
- ...makes people better and keep challenging ourselves to inspire others. About the role: We are scaling and our specialists are leveling up. Now we’re looking for an AI Engineer to build AI agents and solutions that transform engineering workflows. Your impact:...
- ...benchmark fills against references, analyze markouts, and turn what you find into strategy improvements. – Monitor positions, inventory levels and P&L in real time; proactively flag risks, execute adjustments, and continuously improve tooling & monitoring. – Integrate...
- ...technical areas – Experience in making data-driven decisions Compensation offered will be determined by factors such as location, level, job-related knowledge, skills, and experience. . EQUAL OPPORTUNITY We will ensure that individuals with disabilities are...
- ...make better practices easier to follow. – You consider tests, documentation, migrations, debugging, and adoption work beneath Staff-level engineering. WHY AVA LABS? If you’ve ever thought about joining an early stage Web3 company – this is it! We’re a global, world...
$ 119.900
...Documentation to ship integrated, tested, and documented releases. – Take part in the team’s shared medic rotation and resolve engineering-level support cases, feeding learnings back into development. – Contribute to the shared tooling (review, deployment, and test tooling)...- ...quickly. The pace and intensity of the work reflect the importance of the mission. As a result, the way we operate requires a high level of ownership, adaptability, collaboration, and creative problem-solving. At TRM, you should expect: – Priorities and targets to...
- ..., feature flagging, or similar experimentation frameworks). Compensation offered will be determined by factors such as location, level, job-related knowledge, skills, and experience. EQUAL OPPORTUNITY We will ensure that individuals with disabilities are provided...
¿Desea recibir más vacantes?
Suscríbase y reciba vacantes similares a Sr CRA (Level I) - FSP. ¡Sea el primero en aplicar!
