Lead Clinical Research Associate, Melbourne, 2017-09
The World Health Organization recognizes psychiatric disorders as the largest clinical problem in the world in terms of Disability Adjusted Life-Years with an estimated 350M people suffering from major depressive disorder (MDD) alone. Medibio understands that fewer than 10% of individuals receive optimal treatment upon initial assessment, resulting in reduced quality and quantity of life. We want to make it our mission to improve that.
The current state of the art diagnostic tools for clinicians are limited to questionnaires and subjective analysis of lifestyle and emotional response. To help us to continue to provide objective, biomarker-based analytical tools to clinicians at the point of patient contact, we need passionate visionaries who seek to reduce the impact of psychological disorders and aid in proper diagnosis. If you want a career that will challenge and engage you and one where the reward of seeing people get the support and help they need, then Medibio may be the place for you.
Medibio has compiled the world’s largest dataset of physiologic recordings combined with associated psychiatric assessment. The company is now seeking a top notch Lead Clinical Research Associate for our Melbourne office. This Position will join a team made up of fascinating people in the unofficial sporting capital of Australia. We are looking for people who want to have fun, understand what it means to have a start-up mentality, are passionate about the work Medibio is doing, own their work while successfully collaborating in functional and cross-functional teams.
The Lead CRA will support Global Clinical Operations and lead the Australia Clinical Research Associate (CRA) group, being responsible for the performance of trial sites in Australasia region (determined by project), in accordance with Good Clinical Practice (GCP), ICH guidelines and relevant regulations. The key focus for this position will be site qualification, initiation, monitoring and closeout. Reporting to the Director of Clinical Operations, the Lead CRA will contribute to monitoring plans and other trial site documents and tools with ongoing reporting responsibilities for progress of recruitment and overall trial site including document management. The Lead CRA will also act as primary liaison between CRAs and project management, with mentoring, oversight and training responsibilities. The Lead CRA will also be expected to have a close collaboration with data management and medical monitor to support query management and quality reporting.
- Responsible for providing oversight of the entire site management process for the life cycle of the trial sites, with the development and maintenance of trial documents, logs and tracking of site performance metrics.
- Responsible for ensuring site qualification (pre-study), initiation, monitoring and study closeout visits are conducted in accordance with US and AUS federal regulations, Good Clinical Practices, ICH Guidelines, and Standard Operating Procedures and business processes.
- Responsible for monitoring activities of assigned sites and as primary liaison for all clinical monitoring issues, escalating as appropriate to Study Manager and / or Director in accordance with relevant study plans and Standard Operating Procedures and business processes.
- Accountable for the coordination of the CRA team, ensuring appropriate CRA visit scheduling per protocol and monitoring plan with reporting on monitoring activity to include status report, co-monitoring (qualification) visits and trip report metrics.
- Responsible for collaborating with the CRA to develop any Corrective and Prevention Action plan (CAPA) relating to non-compliance at site. Accountable for ensuring that the CAPA is delivered and issues escalated to the Study Manager as required by the clinical project plan and Standard Operating Procedures and business processes.
- Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits, including file review according to the clinical project plan.
- Reviewing and entering all protocol deviations in collaboration with the CRAs and escalating as required.
- Developing and maintaining a country recruitment / retention strategy in collaboration with the Study Manager. Identifying potential risks to the enrollment targets based on feasibility and recruitment updates in collaboration with the Study Manager.
- Responsible for attending, participating and presenting at Investigator meetings as needed.
- Assisting with project specific training, oversight and mentoring of CRAs and in-house staff.
- Supporting the Data Manager, Study Manager and Medical Monitor in communicating and resolving issues and obtaining follow-up information.
- Responsibility to hire, train, motivate and manage a growing number of CRAs based in Australia
- Travel in Australia will be required and may be extensive at times.
- Other duties as assigned
- Minimum of 5-10 years of direct CRA experience within a sponsor or CRO organization, with 3+ years Management experience.
- Minimum Bachelor’s degree in a scientific discipline. Advanced degrees and hands-on medical device experience strongly desired.
- Must be prepared to be a motivator and leader of people.
- Demonstrable computer skills (MS Office, MS Project, PowerPoint).
- Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
- Thorough knowledge of ICH, GCP, CFR and AUS Directives.
- Monitoring experience in Medical Device is preferred.
- Experience of working within a small and / or “start-up organization would be advantageous.
- experienced in managing a varied and complex workload.
- Experienced in building relationships with current and potential investigators
- High energy “hands on” individual who understands clinical development
We are an Equal Employment Opportunity Employer. It is our policy to provide equal employment opportunities to all qualified persons without regard to race, age, color, sex, sexual orientation, religion, national origin, disability, veteran status or marital status or any other proscribed category set forth in state or federal regulations.