We are excited to announce an opportunity for a Study Designer to join our dynamic team at Nucleus Network.  This is a full time, permanent ongoing position in Melbourne.

Who Are We?

As the only global phase 1 clinical trials specialist with facilities in Australia, the USA and the UK, we are committed to “advancing medicine and improving lives” by attracting exceptional talent.

Since our founding in 2004, Nucleus Network has successfully conducted over 1500 phase 1 clinical trials for biotechnology and pharmaceutical companies from the USA, Europe, Australia, Japan, South Korea, Taiwan, and China.

Our organisation is characterised by our core values, outstanding work culture, dedication to staff development, and commitment to providing an optimal work environment.

About the Role

The Study Designer involves the design and development of eSource forms and activity plans that are crucial for the successful execution of clinical studies. The ideal candidate will have a strong background in clinical research, a deep understanding of digital data capture platforms, and a commitment to ensuring participant safety and data integrity.

The Study Designer plays a key role in translating study protocols into operational tasks, ensuring compliance with regulatory standards, and contributing to the advancement of our research objectives.

Job Description

• Form Design: Adapt forms from the library to be study-specific and develop bespoke study-specific forms if required. Add or edit study-specific methods and edit checks. 

• Activity Plan Design: Equivalent to task pad design, plan and map form placement in the required time order, in line with protocol timings/site standards. 

• Review & Approval for Use: Conduct form design review, CRF blank equivalent review, UAT testing, and approve ClinSpark report/PDF. Review activity plans, including assessment window review. 

• Eligibility Mapping: Ensure forms are designed with appropriate ranges and other criteria.

• Development of eSource: Design source in accordance with the Study Protocol and NN SOP.

• Provide feedback on the study protocol, associated manuals and guides, the EDC guidelines, and EDC template.

• Review the protocol and attend pre-initiation/project readiness meetings to discuss study-specific activities from a study design perspective.

• Provide ongoing eSource study-specific support for Protocol Amendments and make changes to eSource as the study progresses.

• Communicate study design adjustments and their impact on the overall study budget.

• Conduct User Acceptance Testing of the Sponsor EDC. 

Technical Competencies:

• Strong understanding and interpretation of study protocol and its translation to clinical operations and participant safety.

• Knowledge of ClinSpark or related eSource/EDC systems and company SOPs.

• Understanding of digital platforms, preferably data capture platforms.

• Knowledge of ICH-GCP and FDA regulations around electronic data capture, including data integrity, data quality, and data management.

• Ability to independently create and review a Task Pad/eSource Activity Pad.

• Ability to independently develop source utilizing a forms library to reflect study protocol and requirements.

• Clinical Research Background. 

About you:

• Excellent communication skills.

• Ability to identify risk and provide appropriate feedback in a timely manner.

• Strong time management, prioritization, and attention to detail.

• A motivated self-starter who is able to work independently with minimal supervision

Mandatory competencies:

• At least 2 years of clinical research experience, including data management principals either at a Biotech, CRO, or Commercial Phase 1 Unit.

• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Demonstrated ability to work independently and manage own time and priorities to deliver across tasks within scope, time, and budget.

Desired competencies:

• Knowledge of CRF design, MS Project and analytical capabilities.

• Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).

• Understanding of data privacy and protection regulations (e.g., GDPR).