Clinical Research Jobs at Novotech
Novotech is seeking an experienced In-house Clinical Research Associate (IHCRA) to provide in-house clinical trial support across global studies. This is a hybrid role. The Clinical Research Jobs at Novotech offer excellent opportunities to work within a leading global CRO, supporting clinical teams in compliance with ICH GCP guidelines, regulatory standards, and internal SOPs. The position is ideal for professionals looking to strengthen their clinical operations expertise while contributing to life-changing clinical research programs.
Job Details:
- Job Title: Inhouse Clinical Research Associate (IHCRA)
- Location: Brisbane City, Queensland, Australia
- Work Mode: Hybrid (minimum 2 days onsite)
- Job Type: Full-time
- Job ID: 3652
- Industry: Clinical Research / CRO / Biotechnology
About the Company:
Novotech is a global, full-service Clinical Contract Research Organization (CRO) headquartered in Sydney, Australia, with 34 offices across Asia-Pacific, North America, and Europe. With over 3,000 employees and more than 5,000 site partnerships worldwide, Novotech delivers comprehensive clinical development services across all trial phases and therapeutic areas. The company is ISO 27001 and ISO 9001 certified, ensuring the highest standards in data security, quality management, and regulatory compliance.
Educational Requirements for the Clinical Research Associate Role:
- Degree or qualification in Life Sciences, Health Sciences, or a related discipline
- Background in clinical research administration is advantageous
- Experience in pharmaceutical, CRO, or healthcare environments preferred
Key Responsibilities of the Clinical Research Associate:
- Provide in-house clinical trial support across assigned projects
- Maintain and manage Trial Master Files (TMF) in compliance with ICH GCP and SOPs
- Track essential documents and support internal and external audits
- Conduct routine quality control (QC) reviews and final TMF reconciliation
- Support the development, collection, and management of essential study documents
- Manage the Clinical Trial Management System (CTMS), ensuring accurate site data, milestones, and compliance metrics
- Coordinate Investigator Site Files and trial material logistics (lab kits, drug supplies, patient materials)
- Maintain safe storage and inventory tracking of clinical trial materials
- Assist CRAs with the preparation and follow-up of onsite or remote monitoring visits
- Support IRB/EC submissions, safety reporting, DSURs, SUSARs, and study close-out activities
Skills Required for the Clinical Research Associate:
- Strong understanding of ICH GCP, Good Documentation Practice, and clinical trial regulations
- Experience with TMF and CTMS management systems
- Excellent organizational and documentation skills
- Ability to manage multiple clinical activities simultaneously
- Strong attention to detail and quality-focused mindset
- Effective written and verbal communication skills
- Proactive, strategic thinking with problem-solving ability
- Ability to collaborate effectively with cross-functional clinical teams
Benefits of the Clinical Research Jobs at Novotech:
- Hybrid working model with flexible work arrangements
- Inclusive and diverse workplace culture
- Paid parental leave for both parents
- Flexible leave entitlements
- Employee wellness programs
- Continuous learning and professional development opportunities
- Supportive leadership and mentoring environment
- Opportunity to work on global, cutting-edge clinical research programs
- Commitment to equity, diversity, and inclusion
