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About the Role
This entry-level Clinical Research Associate (CRA) Training Program at Novotech is designed for individuals aspiring to become CRAs. The program combines formal training with supervised on-the-job experience to develop essential skills in clinical trial conduct, site management, monitoring, and regulatory compliance. It includes an intensive 8-week training period as a CRA Trainee, with a clear progression path to CRA I and CRA II based on performance.
Responsibilities
- Participate fully in the Training Program, including structured learning, functional rotations, and assessments.
- Demonstrate commitment to continuous learning through coaching and mentoring activities.
- Support CRAs with supervised site management activities, including essential documentation and Investigator Site Files.
- Assist with Trial Master File (TMF) coordination, document filing, quality checks, and ongoing completeness.
- Support preparation for monitoring visits, participate in co-monitoring or observational visits, and complete routine follow-up activities under guidance.
- Support data review, query resolution, and maintenance of clinical trial systems under supervision.
- Provide in-house support to clinical trial teams, including communication with internal teams, sites, and vendors.
- Assist with general study administration activities, including basic finance, regulatory, safety, and study close-out support.
- Apply Novotech quality standards, ICH GCP, and regulatory requirements, escalating risks and concerns promptly.
- Adhere to company processes, demonstrate a quality-focused approach, and assist in SOP and process development.
- Understand Novotech’s responsibilities as a service provider and ensure professional communication.
Requirements
- Completed Bachelor's degree in clinical research or a life sciences-related field.
- Prior experience as a Clinical Research Coordinator, Clinical Trial Assistant/Administrator is preferred.
- Therapeutic specialization in oncology, immunology, and CNS is preferred.
- Strong learning agility, attention to detail, organizational, and time management skills.
- Ability to work effectively in a team and use computer-based systems confidently.
- Ability and willingness to travel 8-10 days per month post-training completion.
Skills
- Clinical trial conduct
- Site management
- Site monitoring
- Regulatory compliance
- Documentation management
- Trial Master File (TMF) coordination
- Data review
- Clinical trial systems (CTMS, eTMF, eCRF)
- Communication
- Study administration
- ICH GCP
- Quality standards
Location
- Remote
Work Type
- Full-time
- Hybrid
Experience Level
- Entry-level
Education Level
- Bachelor's degree
Salary/Compensations
- $60,000-$65,000
Benefits
- Flexible working options
- Paid parental leave for both parents
- Flexible leave entitlements
- Wellness programs
- Ongoing development programs
About the Company
- Novotech is a leading clinical research organization.
- We are committed to being an employer of choice for gender equality and providing an inclusive work environment.
- Our team members are passionate about clinical research and biotech.
- We are a Circle Back Initiative Employer and commit to responding to every application.
Equal Opportunity
- 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.
- We are looking for people who are passionate about working in clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.