Clinical Trials Data Quality Associate

• Appointment type: Full time, Fixed term position for 2 years
• Salary Package: From $80,573 to $91,815 p.a. (HEW 5), plus 17% employers superannuation and annual leave loading
• Wallumattagal Campus, Macquarie University (North Ryde)

The Role

The Clinical Trials Data Quality Associate is a specialist role supporting the fast-paced Clinical Trials team with oversight of our data entry, Data Quality and data entry timeliness. They will work closely with the clinical trial coordinators (CTCs) assigned to the trials and liaise with trial sponsor representatives to ensure our clinical trial data accurately reflects trial participants' experiences in the Clinical Trials. Some of the key accountabilities of the role are to:

• Ensure clinical trial data is being entered within 5 days of patient visits and assist the team with data entry as required.
• Ensure data queries are addressed to accurately reflect the source data ensuring database locks are met.
• Maintain oversight of repeated queries and ensure clinical staff are trained to collect trial data accurately and document data consistently.
• Ensure serious adverse events are reported to sponsors within 24 hours of any CTU staff being made aware of the event.
• Support the CTCs following up data collection for their patients from outside institutions such as GPs or hospitals.
• Track clinical trial data entered in the CTU clinical trial management system to support CTU billing and invoicing.
• Communicate effectively and develop strong relationships with sponsors to facilitate monitoring visits including data cleaning and query resolution.
• Review and track data entry metrics for reporting to Clinical Trial Executive.
• Provide general advice and training to others (e.g. Clinical Trial Trainees and Clinical Trial Coordinators) in data entry and data query resolution.

About You

You will be a team player with great interpersonal skills, extraordinary attention to detail, and ideally will have experience with clinical trial data entry and query resolution. Your ability to multi-task, manage competing priorities, identify problems and process solutions will see you succeed in this role. You will be passionate about working in Clinical Trials.

About Us

The Clinical Trials Unit (CTU) undertakes sponsored and investigator initiated Phase I to IV trials across multiple therapeutic areas with multiple Principal Investigators. Our current team of 60 staff (managing nearly 200 trials) are a close knit inclusive team with a supportive culture that values team work and innovation.

The CTU is part of the Faculty of Medicine, Health and Human Sciences (FMHHS) at Macquarie University. FMHHS also has the Macquarie Medical School, the Macquarie University Private Hospital, and runs patient clinics, labs, imaging and a pharmacy all on campus in close proximity to support Clinical Trials, and support providing patients with access to state of the art treatments. The CTU undertakes sponsored and investigator initiated Phase I to IV trials across multiple therapeutic areas with multiple Principal Investigators. Our current team of 60 staff (managing nearly 200 trials) are a close knit inclusive team with a supportive culture that values team work and innovation.

Macquarie is a university engaged with the real and often complex problems and opportunities that define our lives. Since our foundation 54 years ago, we have aspired to be a different type of university. Over the years, we've grown to become the centre of a vibrant local and global community. Connect with us today.

To Apply

To be considered for this opportunity, please apply online and attach your resume and a separate cover letter that demonstrates how you meet to the selection criteria below:

• Tertiary qualification in health, science, data management or equivalent clinical trial experience
• Proven intermediate to advanced computer skills ideally including Clinical Trials Data entry and query resolution
• Demonstrated experience building and managing relationships with key stakeholders
• Demonstrated attention to detail
• Passionate about working in Clinical Trials

Note: This position requires a criminal record check.

Applications for this position are only being accepted from Australian citizens or permanent residents or people currently residing in Australia with full working rights.

Role Specific Enquiries: Nicola Chapman at **************@mq.edu.au

General Enquiries: Jasmine Xia at ***********@mq.edu.au

Applications Close: Sunday, 18th February 2023 at 11:55pm AEST

Note: This position requires you to comply with occupational screening, assessment and vaccinations in line with Macquarie University health requirements. You will also have to satisfy Macquarie University that you meet all background checks (including criminal record and working with children and qualification checks).