Senior / Clinical Research Associate at Cochlear in Sydney

Job description

• An exciting opportunity exists for a Senior / Clinical Research Associate (CRA) to support the delivery of clinical studies and help build Cochlear's clinical monitoring capability. As a key contact for clinical study sites, you will work closely with internal and external stakeholders, supporting the successful delivery of clinical studies. This role offers the opportunity to contribute to a growing function and play an active role in improving processes and ways of working.
• This role provides the opportunity to help shape and strengthen Cochlear's monitoring capability as the organisation expands its clinical research activities. Working within a small team, you will have the opportunity to contribute ideas, influence improvements and take ownership of how the function evolves. You will work on end-to-end lifecycle study management with a small number of sites, allowing you to build strong relationships and enjoy significantly reduced travel compared with many traditional CRA roles

Responsibilities

• Act as the primary contact for internal and external study sites and manage site relationships throughout the study lifecycle.
• Conduct monitoring activities including Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits and Close Out Visits.
• Support study start-up activities, including ethics committee applications and study documentation requirements.
• Deliver site training and ensure site staff are prepared to conduct studies in accordance with requirements.
• Support audits, file reviews and other quality activities to ensure studies are conducted compliantly.
• Contribute to the improvement and development of Cochlear's monitoring capability and support broader business activities where required.

Requirements

• As we grow our operations, we are looking for people who share our passion for delivering quality hearing solutions to our customers. To add value to Cochlear in this role, you'll be able to demonstrate the following skills and experience:
• Solid clinical monitoring experience as a CRA, with at least 2 years of monitoring experience.
• Experience with clinical trial submissions to Ethics Committees / Research Governance Units is desirable.
• Strong stakeholder management and relationship-building skills.
• Confidence managing conflict, negotiating outcomes and handling difficult conversations with key stakeholders.
• Experience supporting clinical studies and working with study sites.
• Ability to work autonomously, exercise sound judgement and manage ambiguity.
• A proactive and action-oriented approach with a strong focus on accountability, meeting timelines and delivering results.
• Flexibility to work within a small team environment and contribute beyond narrowly defined role boundaries when needed.

Skills

Required

• Stakeholder management
• Relationship-building
• Conflict management
• Negotiation
• Autonomy
• Sound judgement
• Proactive
• Action-oriented
• Accountability
• Flexibility
• Clinical monitoring
• CRA (Clinical Research Associate)

Benefits

• At Cochlear we value and welcome the unique contributions, perspectives, experiences, and backgrounds of our employees and aim to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to realise their full potential. Through our internal programs and employee benefits, we aim to create an environment where our people will feel value and supported. Whether your focus is on continuous learning, professional development or simply finding an environment which enables you to thrive whilst balancing family or personal life commitments, then we have several programs in place to support you.