Conducts on-site and remote monitoring for Phase I-IV clinical trials across Australian sites. Responsibilities include site initiation, training, ongoing compliance monitoring, risk mitigation, site performance management, closeout activities, essential document collection, TMF maintenance, and inspection readiness. Acts as the primary liaison between Novartis and study sites while collaborating with clinical project managers and internal stakeholders.
Job Description Summary
This role is based in any city in Australia. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.Join a dynamic team of Clinical Research Associates at the forefront of transforming patient care through trials.
CRA role is to ensure sustainable trial execution at site. Performs on-site and remote monitoring activities related to initiation, conduct and timely completion of Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes accordance with ICH/GCP, local regulations and SOPs. Proactive site performance management (recruitment & quality) and early identification of real site needs and issues as the single best point of contact (internally & externally) for all sites.
Job Description
Key Responsibilities
- Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables with true ownership mindset. Manages assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
- 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. Re-trains site personnel as appropriate. Conducts continuous site monitoring activities.
- Implements site management activities to ensure compliance with protocol.
- Identifies deficiencies in site processes and monitor site processes performed outside the site, works in close collaboration with site on risks mitigation and process improvements. Promotes a compliance culture advocating adherence to highest standards
- Identify deficiencies in site process, work in close collaboration with site on risk mitigation. Establish a strong partnership and true collaboration with the site. Early engagement with site on patient inventory and patient flow in advance
- Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements. Attends onboarding-, disease indication and project specific training and general CRA training as required
- Proactively collaborates with the SSO Clinical Project Manager (CPM) and CRA Manager as well as other relevant business units. Participates in audit organization and inspection readiness activities for monitoring and site. Collaborates with internal stakeholders and site personnel. Ensures the site Investigator Folder is up to date. Responsible for collecting essential documents from site and accountable to keep TMF(s) up to date
Essential Requirements:
- Degree in scientific or healthcare discipline. Up to 2 years pharmaceutical industry experience or other relevant experience
- Central/in-house monitoring or field monitoring experience is desirable. Decision capability, Excellent time management, organization and risk-based mindset.
- Early adopter and open mindset across borders to support one study approach. Good knowledge of drug development process. Clinical and therapeutic knowledge
- Knowledge of international standards (GCP/ICH, FDA, EMA). Understanding the purpose of the CRA.
- Fast change adaptability to best partner & influencing with sites on fast changing landscape. Trust and rapport building.
- Ability to travel domestically. A minimum of 50% overnight travel may be required
- Good communication skills, relationship management, excellent communicator, ability to manage sites independently, Good analytical thinking
- Ability to anticipate potential issues and take appropriate actions with or without supervision and Digital & tech capabilities.
Skills Desired
Central Monitoring, Clinical Research, Clinical Site Monitoring, Clinical Study Management, Clinical Study Reports, Clinical Trial Management, Clinical Trials, Collaboration, Collaborative Mindset, Data IntegritySimilar Jobs
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