Key Responsibilities
* This position is open to candidates based in Sydney, Melbourne, Brisbane or Adelaide.
The Lead Clinical Research Associate (CRA) will manage, deliver and/or perform full clinical site monitoring services for one or more projects. This may include multiple services, complex in nature and/or running on a multinational scale. In-house based position responsible for designing and overseeing project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that align with SOPs, study guidelines and GCP best practices.
In this function, the Lead CRA will act as primary liaison between CRAs and project teams. They may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. The representative will maintain collaborative relationships with stakeholders by representing the corporation.
Subject Matter Expertise
* Act as subject matter expert, mentor, coach and/or provide performance feedback to peers.
* Assist with selection, hiring, training, and supervision of CRAs as needed. Perform co-monitoring and training visits with CRAs.
* When required, act as the first escalation point for resolving site/patient issues or addressing Sponsor concerns.
* May represent Director, Monitoring and Site Management or Manager, Clinical Site Management in business development initiatives with a site monitoring focus.
Project Monitoring Leadership
* May be assigned Lead CRA role and manage monitoring services for a group of projects and/or CRAs on large/complex project(s). Direct day-to-day activities and review/approve monitoring reports.
* Function as liaison between CRAs and other functional teams. Escalate concerns and issues to management as needed.
* Participate and/or present at study team, kickoff and investigator meetings. Act as primary contact to sponsors for all monitoring related issues.
Site Recruitment and Setup
* Identify and recruit site investigators. Coordinate movement and delivery of trial materials, samples, tests and forms, including investigational product, protocols, SOPs, CRFs, project documents, forms and support tools.
* Ensure SOPs are in place to optimize patient recruitment. Provide guidance to site teams on inclusion/exclusion criteria.
Investigational Site Monitoring
* Primary clinical site contact.
* May act as primary contact for questions or issues arising from investigational sites.
* Oversee overall integrity of the study to promote positive working relationships with the site and staff.
* Facilitate and support site staff with access to study systems. Ensure sites are compliant with project-specific training requirements.
* Ensure all site-related issues are followed until resolution.
* Coordinate delivery of clinical site communications. Collaborate with project teams to ensure investigational sites receive accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project lifecycle.
Requirements
* A minimum of a college diploma/degree and 4-6 years of related experience are required.
* The successful candidate must exhibit self-motivation, strong communication skills, and a commitment to achieving positive results.
* Strong attention to detail and keenness to understand the importance of building collaborative relationships are essential.
* Ability to engage in continuous learning and self-development.
* Ability to continually foster teamwork.
Working Conditions
* Home-based
* Regular travel