CRA Senior

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Summary

Planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. May interact with investigational sites, clinical consultants, Contract Research Organizations and other vendors. Collaborates with country medical/clinical colleagues, global clinical teams and directs activities to execute and deliver the assigned studies. Monitors patient data and study-related information related to clinical study sites and clinical trial participation. Ensures the investigator adheres to research protocols, regulatory requirements and good clinical practices and provides input into data validation plan. Provides timely and accurate monitoring of patient data and study-related information from source documents, research records, and site visits where applicable. May monitor study sites and audit facility selection.

• Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectations on milestones and deliverables with true ownership mindset.
• Manage assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
• Perform Site Initiation Visits, ensure site personnel are fully trained on all trial-related aspects; provide ongoing training for amendments and new site personnel as required; retrain site personnel as appropriate.
• Conduct continuous site monitoring activities (onsite and remote). Implement site management activities to ensure compliance with protocol, ICH/GCP, global and local regulations including Health Authorities, IRB/EC, data privacy requirements, and GDP/Novartis standards.
• Identify deficiencies in site processes and monitor site processes performed outside the site; work with site on risk mitigation and process improvements.
• Promote a compliance culture, ensuring human subject protection and reliability of trial results at all times.
• Establish strong partnerships with sites to increase patient density and reduce issues at the site.
• Engage with sites on patient inventory and patient flow prior to SIV in collaboration with global and local study teams.
• Perform Site Closeout activities per SOPs and applicable regulations, ensuring follow-up activity and archiving requirements are understood by the site.
• Attend onboarding, disease indication and project-specific training and general CRA training as required.
• Collaborate with the SSO Clinical Project Manager, CRA Manager, MSL, CRMA and medical advisor to optimize recruitment, site development and data quality.
• Share relevant site insights with internal stakeholders to improve the one Novartis approach to sites.
• Participate in audit organization and inspection readiness activities for monitoring and site-related activities; implement corrective actions within specified timelines.
• Collaborate with internal stakeholders and site personnel to manage data query resolution and ensure timely and accurate data entry.
• Keep the site Investigator Folder up to date and collect essential documents from site; maintain TMF(s) up to date.

Work Experience:

• Minimum 5 years pharmaceutical industry experience in all aspects of monitoring and site management
• Operations Management and Execution
• Collaborating across boundaries
• Project Management
• People Leadership

Skills:

• Fast change adaptability to partner with sites on a changing landscape
• Trust and rapport building
• Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings
• Minimum 50% overnight travel may be required
• Good communication skills, ability to influence others and relationship management
• Excellent communicator and presenter (oral and written)
• Ability to manage sites independently with minimal supervision
• Good analytical thinking
• Ability to anticipate potential issues and take action with or without supervision
• Digital and tech capabilities

Languages:

• English

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