Job Description

About The Role:

The Clinical Research Associate (CRA) Training Program is an entry-level role for those aspiring to become a CRA through Novotech's structured Training Program. The role combines formal training with supervised, on-the-job experience to build foundational skills in clinical trial conduct, site management, site monitoring, and regulatory compliance. This is an intensive 8-week Training Program as a CRA Trainee, supporting CRA activities under close supervision, with a defined pathway toward progression to CRA I subject to performance and readiness. Upon moving to a CRA I role, the Training Program continues close supervision, with a defined pathway toward progression to CRA II subject to performance and readiness

The anticipated start date for this cohort is Jan 4, 2027.

Visa sponsorship/authorization is not supported for this role.

Responsibilities:

• Participate fully in the Training Program, including structured learning, functional rotations and assessments.
• Demonstrate commitment to continuous learning by participating in coaching and mentoring activities with Line Managers, cross functional stakeholders, the assigned Senior CRA mentor, and graduate cohort peers.
• Support CRAs with supervised site management activities, including maintenance of essential site documentation and Investigator Site Files.
• Assist with Trial Master File (TMF) coordination, document filing, quality checks and ongoing completeness.
• Support preparation for monitoring visits, participation in co-monitoring or observational visits, and completion of routine follow-up activities under guidance.
• Support data review, query resolution and maintenance of clinical trial systems (e.g. CTMS, eTMF, eCRF) under supervision.
• Provide in-house support to clinical trial teams on assigned studies, including communication with internal teams, sites and vendors to request documentation, resolve routine queries and perform elements of in-house CRA activities, subject to training completion and demonstrated capability.
• Assist with general study administration activities, including basic finance, regulatory, safety and study close-out support under supervision.
• Apply Novotech quality standards, ICH GCP and regulatory requirements in all activities, escalating risks, issues and safety concerns promptly to the supervising CRA or Line Manager.
• Be aware of and adhere to company processes relevant to clinical trial delivery, demonstrate a quality-focused approach to work, and assist in the review and development of clinical SOPs and processes as appropriate.
• Understand Novotech's responsibilities as a service provider within the pharmaceutical and biotech industry and ensure all internal and external communications reflect a professional company image.

Minimum Qualifications & Experience:

• Completed Bachelor's degree in clinical research, or life sciences-related field.
• Prior experience as a Clinical Research Coordinator, Clinical Trial Assistant/Administrator with therapeutic specialization in oncology, immunology and CNS would be preferred.
• Strong learning agility, attention to detail, organizational and time management skills, with the ability to work effectively in a team and use computer-based systems confidently.
• Ability and willingness to travel 8-10 DOS post completion of the training program.

The salary range for this role is $60,000-$65,000 dependent upon experience and qualifications. Upon successful completion of the training program, a salary increase will be provided.

Novotech is proud to offer a great workplace. 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. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.

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