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About the Role
The Inhouse Clinical Research Associate (IHCRA) provides in-house support to the clinical team, ensuring adherence to project requirements, ICH GCP guidelines, 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 the preparation of onsite or remote monitoring visits and follow-up action items.
- Assist with IRB submissions, including safety reporting, tracker management, and site communication during project maintenance and close-out phases.
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.
- A minimum of 1 year of experience as an inhouse CRA or in relevant clinical administration roles.
Skills
- Strategic mindset
- Ability to gain insights and make proactive decisions quickly
- Partnership and collaboration skills
- Communication skills
Location
- Remote
Work Type
- Full-time
Experience Level
- 1+ years experience
Benefits
- Flexible benefits framework (NovoLife)
- Mentorship opportunities
- Professional development programs
About the Company
- Novotech is a global full-service clinical Contract Research Organization (CRO).
- Novotech is a globally recognized leader in clinical research and scientific advisory services.
- 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).
- Fosters an environment that reflects life-changing work.
- Expanded global footprint with 30+ offices across Asia-Pacific, the United States, and Europe.
- Unites professionals from diverse backgrounds to advance therapies.
- Offers trust, flexibility, and autonomy.
- Empowers team members to create an effective work-life balance.
- Provides a platform for driven individuals to achieve personal growth.
- Has advanced therapeutic and regulatory expertise.
- Possesses the ability to execute across markets.
- Employs a client-centric service model.
- Offers a trusted, long-term partnership and an accelerated path to market.
- Provides opportunities to develop careers in a diverse and supportive global organization with a collaborative culture.
- Works with clients on the cutting-edge of life sciences.
- Features empowered teams with a shared commitment to success.
- Fosters a culture where every voice is heard and valued.
- Provides ongoing support from senior stakeholders and the leadership team.