Graduate Clinical Research Associate (CRA)

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.
• There is 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.
• Anticipated start date for this cohort: Jan 4, 2027.
• Visa sponsorship/authorization is not supported for this role.

Key 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.

Qualifications

• 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 days on site (DOS) post completion of the training program.