• Part-Time (0.6 to 1.0FTE), 12-Month Contract

At the South Australian Health and Medical Research Institute (SAHMRI), we are committed to achieving innovative, ground-breaking health and medical research that fundamentally improves the quality of life for all people.

SAHMRI Women and Kids (SWK) are seeking a highly motivated and experienced Project Manager/Clinical Trial Coordinator to manage and lead the coordination of high quality single and multi-centre trial activities, in adherence with Good Clinical Practice (GCP) and Ethics requirements. In this position, you will work closely with the Trial Leadership Team, broader SWK teams and other staff at SAHMRI and relevant study sites. This diverse role will involve interacting with a range of external stakeholders including health professionals, internal and external investigators, study researchers, clinical staff and study participants.

About the Role

Key responsibilities include:

• Project manage, coordinate and conduct SAHMRI clinical trial/s in accordance with study protocols and targets and with successful adherence to Good Clinical Practice guidelines (GCP) and HREC requirements.
• Assist the facilitation and implementation of the trial protocol as directed by the trial leadership team
• Liaise and maintain productive relationships with an extensive network including health professionals, internal and external investigators, researchers, clinical staff and study participants
• Work with the chief investigator and stakeholders to scope and plan project deliverables
• Identify and implement strategies to enhance the recruitment, data quality, compliance and retention of participants
• Continuously monitor trial processes and recruitment status and recommend improvements to meet project milestones and to adhere to quality standards
• Contribute to the project review process by identifying and reporting on project risks and implementing efficient risk-management and contingency strategies as directed
• Develop accurate and meaningful numerical reports and graphing for tracking and monitoring study progress and interpret and report on these regularly to project leadership
• Prepare, submit and maintain records of ethics applications for various committees including hospital approval processes
• Coordinate the development of forms, questionnaires, procedure manuals, trial protocols, CRFs, SOPs and other documents as required
• Organise, attend and present at healthcare professional seminar and educational workshops to increase engagement and encourage active participation in SWK research initiatives.
• In conjunction with IT experts, actively review and give feedback on the design and development of web-based software to manage clinical trial/s and data collection
• Manage a schedule of project meetings
• Prepare meeting materials including agendas, minute taking and the follow up of action items
• Conduct all aspects SWK clinical trials in accordance with ICH GCP guidelines and the trial protocol
• Manage the day- to- day operations of the project

About You

The successful candidate will possess the following key attributes:

• Hold a degree in a relevant field and/or demonstrated experience managing projects.
• Training in ICH-GCP highly desirable
• Proven experience in the coordination of clinical trials, involving women, children and/or infants preferable.
• Experience in clinical trial management.
• Demonstrated skill in project management including project planning, executing plans, monitoring and reporting, achieving milestones and managing relationships.
• Proven experience in a clinical trials environment, including recruitment, enrolment and data management.
• Demonstrated high-level project skills through to completion.
• Excellent planning and organisational skills, with the ability to establish priorities and allocate resources to meet tight deadlines
• Experience in preparing and submitting ethics and local governance applications preferable
• Relationship management skills, including the ability to interact with, and gain cooperation from with a variety of stakeholders
• Experience in the use of project management software and related programs
• Experience in or knowledge of Australian health/hospital systems and experience in working in a hospital setting, including ability to understand the implications and maintain confidentiality and privacy
• Knowledge of GCP.
• Ability to write clear, succinct and accurate reports.
• Ability to demonstrate flexibility and adaptability in the workplace, including the ability to deal with emerging issues in a timely manner
• Ability to work within a team environment whilst setting personal targets to achieve required results.

Special Requirements

• Primarily located at either Women’s and Children’s Hospital with some travel required between hospital and SAHMRI sites including SAHMRI North Terrace or other participating centres.
• Interstate travel may be required.
• Some out of hours work may be required.
• DCSI Working with Children screening is required
• All employees are required to be immunised in accordance with the requirements of the Hospital in which they are working or be willing to be vaccinated at the cost of the Institute.

Everything we do is underpinned by our core values and our institute is dedicated to grow a culture that pursues, enables and demands research excellence. We are proud of the work we do and work hard as a team to make a positive difference to the community. Our values of excellence, innovation, courage, integrity and teamwork are what help us achieve our goals. If these are also your values and goals, apply today.

As a not-for-profit organisation, SAHMRI employees can access salary packaging options up to $15,900. Salary packaging lets you pay for things like the everyday costs of living with money from your salary before tax. This reduces your taxable income, meaning you could pay less tax and take home more of what you earn. For more information on salary packaging please see the Maxxia website.

For a copy of the position description, please click here.

For more information, please contact Anna Seamark (Business and Operations Manager, SAHMRI Women and Kids) at [email protected] using the subject line: Project Manager / Clinical Trial Coordinator enquiry via EthicalJobs.

Aboriginal and Torres Strait Islander people are strongly encouraged to apply

SAHMRI is a member of the Athena SWAN Science in Australia Gender Equity program. We have been awarded Bronze status for our commitment to advancing the careers of women, trans and gender diverse individuals in STEMM.