Senior Clinical Research Associate

노바티스

서울시
정규직
풀타임

2개월 전

About the roleInternal Role Title: Senior Clinical Research AssociateLocation: Seoul, Korea #LI-HybridNovartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.About the Role:This role is assigned to more sophisticated trials and or to less experienced sites where applicable. This person takes on the responsibility to participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines, and participates in multi-disciplinary teams locally and globally to evaluate and implement process improvements.
Key Responsibilities:

Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on achievement and results with true ownership attitude. Handles 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 (onsite and remote). Implements' site management activities to ensure compliance with protocol, ICH/GCP, global and local regulation including Health Authorities, IRB/EC, data privacy requirements, global and local processes as applicable. Documentation according to GDP and Novartis standards.
Identifies deficiencies in site processes and supervise 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 the highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times
Establish a positive relationship and true collaboration with the site, to increase patient density and decrease issues at site. Early engagement with site on patient inventory and patient flow in advance of SIV in close collaboration with global and local study team
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 relevant teams to ensure efficient recruitment, site development and data quality.
Ensures that relevant site insights are shared with internal partners such as site partnership manager, medical advisor, MSL and CRMA etc. to improve one Novartis approach to sites. Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines.
Collaborates with internal partners and site personnel to handle data query resolution process and to ensure timely and accurate data entry. Ensures the site Investigator Folder is up to date. Responsible for collecting crucial documents from site and accountable to keep sTMF(s) up to date.

Role RequirementsEssential Requirements:

At least 6 years working experience in global SIT monitoring experience. Degree or equivalent experience in scientific or healthcare subject area
Proficient in both written and spoken English and country language. Decision capability
Excellent time management and organization capabilities, including ability to prioritize and multi-task. Knowledge of international standard and understanding the purpose of the CRA
Good knowledge of drug development process specifically in clinical trial or search, clinical and therapeutic knowledge
Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings.
Good communications skills, relationship management, ability to handles site independently, good analytical thinking and ability to anticipate potential issues and take appropriate action.
Digital and tech capabilities.

Why Novartis?Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-cultureYou'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewardsJoin our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/networkFunctional AreaResearch & DevelopmentDivisionDevelopmentBusiness UnitGCO GDDEmployment TypeRegularCommitment to Diversity & Inclusion:We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Shift WorkNoEarly TalentYes

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