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About the Role
The Inhouse Clinical Research Associate (IHCRA) provides in-house support to the clinical team, adhering to project requirements, ICH GCP guidelines, local/global regulatory requirements, and company SOPs.
Responsibilities
- Support the clinical team’s inhouse activities on assigned projects.
- Coordinate and maintain clinical study documentation in the Trial Master Files (TMF), including document tracking, audit preparation, routine QC reviews, and final reconciliation.
- Support the clinical team in essential document development, collection, and management, including translations, following Good Documentation Practice, ICH GCP, and company SOPs.
- Manage the Clinical Trial Management System (CTMS), ensuring high site compliance scores and timely data entry.
- Update and maintain site milestones, subject tracking, and PISCFs for accuracy and completeness.
- Create Investigator Site Files and coordinate the ordering, dispatch, and tracking of trial materials.
- Ensure safe and orderly storage of study materials and maintain stock reports.
- Assist CRAs with preparing for monitoring visits and following up on action items.
Requirements
- Relevant experience/qualifications in Life Sciences or related field or administration is preferable.
- Experience working in the pharmaceutical, CRO, or healthcare industry is advantageous.
- At least 12 months of experience as an inhouse CRA or in a relevant administration or support role.
Skills
- ICH GCP guidelines
- Local or global regulatory requirements
- Novotech or Client SOPs
- Good Documentation Practice
- Clinical Trial Management System (CTMS)
- Strategic mindset
- Ability to gain insights and make proactive decisions quickly
- Partnership and collaboration
Experience Level
- 12 months experience as inhouse CRA or relevant administration or support role
Education Level
- Relevant qualifications in Life Sciences or related field or administration
Benefits
- NovoLife, our flexible benefits framework
- Mentorship opportunities
- Professional development programs
About the Company
- Novotech is a global full-service clinical Contract Research Organization (CRO).
- We are a globally recognized leader in clinical research and scientific advisory services.
- We have an award-winning workplace culture that values ambition, innovation, and growth.
- Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE).
- We have expanded our global footprint with 30+ offices across Asia-Pacific, the United States, and Europe.
- We unite professionals from diverse backgrounds to advance therapies that improve patient outcomes worldwide.
- We offer trust, flexibility, and autonomy.
- We have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model.
- We provide a trusted, long-term partner and an accelerated path to bring life-changing advances to market.
- We foster a collaborative culture where every voice is heard and valued.
- We provide ongoing support from senior stakeholders and leadership team.
Equal Opportunity
- Employer of Choice for Gender Equality (EOCGE)