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Inhouse Clinical Research Associate - Job Opportunity at Novotech

Sydney, Australia
Full-time
Mid-level
Posted: March 14, 2025
On-site
AUD 85,000 - 110,000 per year based on Sydney market rates for mid-level CRA positions

Benefits

Comprehensive parental leave for both parents
Flexible working arrangements
Wellness programs
Professional development opportunities
Inclusive workplace culture
Flexible leave entitlements

Key Responsibilities

Lead clinical documentation management and quality control for Trial Master Files (TMF)
Coordinate essential document development and translation processes
Manage Clinical Trial Management System (CTMS) compliance and data integrity
Oversee investigator site file creation and trial materials logistics
Support CRA team with monitoring visit preparation and follow-up
Facilitate IRB submissions and safety reporting processes

Requirements

Education

Degree in Life Science or related field

Experience

Relevant experience in Life Sciences administration

Required Skills

ICH GCP knowledge Clinical trial documentation expertise CTMS proficiency Project coordination Quality control Document management IT systems proficiency Ability to work under pressure Deadline management
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Sauge AI Market Intelligence

Industry Trends

Increasing demand for in-house CRAs due to growing complexity of clinical trial documentation requirements Shift towards digital trial master file systems requiring specialized expertise in electronic documentation management Rising importance of data integrity and regulatory compliance in clinical research operations Growing focus on Asia-Pacific region as a key clinical trial market

Role Significance

Typically part of a 5-10 person clinical operations team, supporting multiple CRAs and project managers
Mid-level position with significant operational responsibility but limited strategic decision-making authority

Key Projects

Clinical trial documentation management and standardization initiatives Quality control system implementation Regulatory compliance projects Site file management optimization

Success Factors

Strong attention to detail and organizational skills Ability to manage multiple concurrent projects while maintaining quality standards Effective communication with diverse stakeholders including CRAs, site staff, and regulatory bodies Proactive problem-solving approach to documentation and compliance challenges

Market Demand

High demand driven by expansion of clinical trials in Asia-Pacific region and increasing regulatory requirements

Important Skills

Critical Skills

ICH GCP knowledge - Essential for ensuring regulatory compliance and trial integrity CTMS expertise - Critical for maintaining trial data accuracy and site compliance Documentation management - Fundamental to role success and regulatory compliance

Beneficial Skills

Project management methodologies Multiple language capabilities Electronic trial master file systems expertise Quality management systems knowledge

Unique Aspects

Strong focus on Asia-Pacific clinical trial operations
Emphasis on technology integration in clinical research
Comprehensive support for professional development
Clear commitment to diversity and inclusion in workplace

Career Growth

2-3 years in role before advancement, depending on performance and project exposure

Potential Next Roles

Senior Clinical Research Associate Clinical Project Manager Clinical Operations Manager Quality Assurance Specialist

Company Overview

Novotech

Novotech is a leading Asia-Pacific focused Contract Research Organization (CRO) with strong presence in Australia and expanding operations across the region

Top-tier regional CRO with growing global recognition in biotech and pharmaceutical research services
Strong Australian base with significant regional operations across Asia-Pacific
Professional environment with emphasis on work-life balance and career development, demonstrating commitment to diversity and inclusion
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