About the Opportunity:
The Inhouse Clinical Research Associate (IHCRA) provides in-house support to the clinical team according to project requirements, ICH GCP guidelines, local or global regulatory requirements and Novotech or Client SOPs.
Responsibilities:
- Support the clinical team’s inhouse activities on assigned projects.
- Organize and manage study-related documentation to ensure proper record-keeping. This includes tracking files, preparing for internal and external reviews, conducting quality checks, and ensuring all records are properly stored according to standard guideline.
- Support with collecting, translating, and managing important study documents following standard guidelines and procedures
- Maintain and update the project management system, ensuring all records related to research sites, study progress, and participant tracking are accurate and up to date.
- Prepare and distribute study materials (e.g., patient instruction cards and diaries, lab supplies, drug supplies, etc.) and track their usage to ensure smooth operation.
Minimum Qualifications & Experience:
- Relevant experience/qualifications in Life Sciences or related field or administration would be preferable.
- Work experience at a Korean company is preferred.
- Experience working in the pharmaceutical, CRO((Contract Research Organization), healthcare industry, and Korean company is advantageous.
- Must be proficient in speaking, writing and reading Korean.
- Beginner-level English proficiency, including basic reading and writing, is acceptable.
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.
Novotech is a global full-service clinical Contract Research Organization (CRO).
Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance.
Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.
