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Job Details
Novartis
Sr. CRA – Remote – West Region (multiple positions)
Job Description
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
This is a Remote Based position and will be covering our West Region. Candidates must be located near an airport hub, preferably in CO, UT, WY, ND, SD, or IA. The successful candidate will be required to travel up to 80% of the time, within the following locations: CO, UT, WY, ND, SD, IA, CA, OR, WA, ID, MN, WI, IL, MT, NV, KS, NE and MO.
Job Summary:
The Senior CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials within the country. In addition, the Senior CRA is responsible to deliver data within timelines and required quality standard, and for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.
Your responsibilities include, but are not limited to:
Trial Monitoring strategy:
• Conducts feasibility and screen potential Investigators and networks to evaluate capabilities for conducting clinical trials
Allocation, initiation and conduct of trials:
• Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommends sites to participate in clinical trial
• Is the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries
• Manages assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures
• Facilitates the preparation and collection of site and country level documents
• Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Retrains site personnel as appropriate
• Conducts continuous monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety
• Is accountable for continuously updating all electronic systems (global and local) relevant to perform job functions
• Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
• Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements
• Performs additional task as assigned
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
This is a Remote Based position and will be covering our West Region. Candidates must be located near an airport hub, preferably in CO, UT, WY, ND, SD, or IA. The successful candidate will be required to travel up to 80% of the time, within the following locations: CO, UT, WY, ND, SD, IA, CA, OR, WA, ID, MN, WI, IL, MT, NV, KS, NE and MO.
Job Summary:
The Senior CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials within the country. In addition, the Senior CRA is responsible to deliver data within timelines and required quality standard, and for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.
Your responsibilities include, but are not limited to:
Trial Monitoring strategy:
• Conducts feasibility and screen potential Investigators and networks to evaluate capabilities for conducting clinical trials
Allocation, initiation and conduct of trials:
• Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommends sites to participate in clinical trial
• Is the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries
• Manages assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures
• Facilitates the preparation and collection of site and country level documents
• Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Retrains site personnel as appropriate
• Conducts continuous monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety
• Is accountable for continuously updating all electronic systems (global and local) relevant to perform job functions
• Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
• Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements
• Performs additional task as assigned