Clinical Research Project Lead

The Opportunity

We are looking for a Clinical Research Project Lead to join the Lions Vision Trials team at the Lions Eye Institute.  Lions Vision Trials are a division of the Lions Eye Institute that conduct all phases of industry sponsored and investigator initiated clinical trials in ophthalmology.

This role is being offered on a full-time basis for a 12-month fixed-term contract with the possibility of extension.  Reporting to the Clinical Trials Manager, this position will work collaboratively as part of the Lions Vision Trials team, to undertake the following responsibilities:

• Lead the delivery of Investigator Initiated Trials and research projects according to the Protocol through all stages of the study lifecycle
• Oversee the Governance processes for Investigator Initiated Trials and Research Projects. Preparation and submission/implementation of HREC
• Assist with development of study protocol to support regulatory compliance and operationalisation of study
• Support operational study coordination activities when required, including but not limited to patient scheduling, running patient visits, and data collection/entry.
• Develop and manage relationships with clinical investigators, site staff and key stakeholders to ensure alignment with project operational plan to ensure successful enrolment and execution of the projects.
• Manage critical components of clinical operations, including study planning, clinical supply logistics, data/sample/document management, and quality assurance.
• Develop and execute study documents as required such as monitoring plans, data management plans and procedural manuals in collaboration with the Clinical Trials Manager and QA Coordinator.
• Ensure compliance with regulatory requirements, including the review of study reports, clinical data, and documentation.
• Anticipate, identify, track and manage study risks.
• Uphold compliance with GCP, ICH guidelines, SOPs, and relevant regulatory frameworks (TGA, FDA, EMA)
• Conduct study team meetings and provide regular updates to stakeholders.
• Identify opportunities for innovation and operational improvement across clinical execution.
• Complete ongoing and ad hoc reporting when required for study performance, regulatory and financial reporting.
• Lead in developing data collection tools and REDCap or other database platforms for data management.

• Support media and advertising processes where required, including development of resources such as posters and flyers

• Lead in the development of SOPs where appropriate

• Provide mentoring and operational leadership to project staff

• Provide performance feedback, coaching and development to ensure optimal individual and team performance
• Line management for study team members as appropriate

Selection Criteria

At LEI, cultural fit is important to us. As such, candidates will be assessed against a broad range of technical and behavioural selection criteria including the following:

Essential

Qualifications

• Proven experience (minimum 5 years) as a clinical trials coordinator in a clinical setting

• Working experience in preparing Human Research Ethics Committee and Research Governance submissions

• Solid understanding of regulatory requirements for Investigator Initiated Studies

• Experience in supporting Protocol development for clinical research
• Proven experience with the management of direct reports in a clinical research setting
• Working knowledge of Good Clinical Practice (GCP) guidelines
• Excellent organizational and communication skills
• Strong attention to detail and data accuracy
• Proficiency in managing databases and patient data
• Ability to work independently and as part of a team
• Demonstrated strong skills in computer literacy (i.e. Microsoft office)

Desirable

• BSc degree in clinical research, life sciences, or related field
• Experience in ophthalmology
• Experience conducting Investigator Initiated Studies
• Experience coordinating investigator initiated clinical trials
• Working knowledge of REDCap would be an asset

Click theAPPLYbutton to submit your application for this position. For further enquiries or job specific details, please email the recruitment team on: 

We strongly promote a culture of diversity and inclusion at Lions Eye Institute. Aboriginal and Torres Strait Islander applicants are encouraged to apply.

A National Police Clearance will be required from the successful applicant.

Only shortlisted applicants will be contacted.