Senior Clinical Research Associate (REMOTE) - MN

328184BR
USA

Job Description

400+. The number of dedicated and inspired professionals in the US TMO function who are empowered to ask new questions and make bold decisions to bring lifesaving medicines and treatments to patients. Come join our curious and unbossed team and make an impact on patient’s lives every day!
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** This role will consider experienced candidates who live in Minnesota (MN). There is no relocation for this position.
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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. You will deliver data within timelines, and required quality standards, and for adherence to monitoring procedures aligned with GCP, ICH, local regulations, and SOPs.

Trial Monitoring strategy:
• Conduct feasibility and screen Investigators and networks to evaluate proficiency to conduct clinical trials


Allocation, initiation, and conduct of trials:
• Conduct site selection and evaluate competencies. Recommend sites to participate in clinical trial. Act as liaison to sites to ensure successful collaboration, meeting Novartis expectation on landmarks, and deliveries; collaborate with the CRA Group Head/CSM to ensure recruitment plans and execute contingency plans
• Manage assigned sites and networks, if applicable, conduct Phase I-IV protocols.
• Facilitate the preparation and collection of site and country level documents
• Perform Site Initiation Visit (SIVs), ensure site staff are trained on trial related aspects. Perform continuous re/training for amendments and new site staff. Conduct continuous monitoring activities (onsite and remote). Implement site management activities in compliance to secure data integrity and patient safety
• Continuously update electronic systems (global and local) relevant to perform job functions
• Ensure study targets for sites are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.). Perform Site Closeout activities and ensure site awareness of follow-up activities and archiving requirements
• Attend onboarding, disease indication and project specific training and general CRA training
• Participate from audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions


Deliver quality data and compliance to quality standards:
• Monitor studies as per current legislations, ICH/GCP and Novartis standards. Ensure timely delivery, of high quality, robust, and reliable data of the monitored sites to support the goals of Trial Monitoring
• Collaborate with internal partners and site personnel to manage data query resolution process to ensure timely and accurate data entry
• Ensure the site Investigator Folder is up to date. Collect crucial site documents and manage keeping the sTMF(s) current.
• Participate in multi-disciplinary teams within CPO and globally to evaluate and implement process improvement; support the implementation of innovative processes and technologies


Budget and Productivity:
• Negotiate investigator remuneration; prepare financial contracts between Novartis and investigational sites and investigators. Ensure payments triggered to investigational sites


https://www.youtube.com/watch?v=HUSA096Nn_E

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Global Drug Development
GDO GDD
USA
Minneapolis, MN
Research & Development
Full Time
Regular
No
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328184BR

Senior Clinical Research Associate (REMOTE) - MN

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