Hybrid opportunity at
PSI CROSenior Clinical Research Associate
PSI CRO is a privately owned clinical research organisation founded in 1995. It runs global trials of new medications for pharmaceutical and healthcare clients and reports…
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About This Role
PSI CRO is a privately owned clinical research organisation founded in 1995. It runs global trials of new medications for pharmaceutical and healthcare clients and reports roughly 3,000 staff, whose studies generate the safety and efficacy evidence that regulators and patients rely on. In this position, the Senior Clinical Research Associate takes charge of the clinical side of full-service projects in Australia. Monitoring work covers site selection, study start-up, routine…
Job Description
PSI CRO is a privately owned clinical research organisation founded in 1995. It runs global trials of new medications for pharmaceutical and healthcare clients and reports roughly 3,000 staff, whose studies generate the safety and efficacy evidence that regulators and patients rely on.
In this position, the Senior Clinical Research Associate takes charge of the clinical side of full-service projects in Australia. Monitoring work covers site selection, study start-up, routine visits and close-out visits, along with case report form review, checks of source records and query handling. The associate keeps sites and investigators engaged, watches over participant rights, safety and wellbeing, and helps gather the regulatory paperwork that sites need. Other tasks include training investigators and site teams, preparing slides for investigator meetings and supporting audit readiness.
The associate also coaches and supervises junior CRAs and may later move toward Lead Monitor duties. Applicants need a life sciences degree or a comparable blend of study and practical experience, four or more years working alone as an on-site monitor in Australia, and hands-on exposure to every type of monitoring visit on Phase II and/or Phase III trials. Background in inflammatory bowel disease, oncology or infectious disease studies would be an advantage. The arrangement is hybrid: Sydney-based staff are asked to be in the office three days a week.
Responsibilities
- Organise and run site selection, start-up, routine and end-of-study monitoring visits
- Review case report forms, check source records and resolve queries
- Keep sites and investigators engaged and maintain good working ties
- Train investigators, site teams and project groups
- Prepare investigator meeting presentations and help with audits
- Help regulatory affairs gather site documents
- Coach and supervise junior CRAs on their study responsibilities
Requirements
- Life sciences degree or a comparable mix of study, training and experience
- Four or more years of solo on-site monitoring work in Australia
- Hands-on exposure to all monitoring visit types on Phase II and/or III trials
- Willingness to travel
- Working knowledge of Microsoft Office applications
- Ability to plan and perform within a dynamic team
- Good communication, teamwork and problem-solving ability
Qualifications
- Background in inflammatory bowel disease, oncology or infectious disease studies is a plus
Core Skills
Benefits
- Competitive salary
- Hybrid pattern: two flexible days plus three office days for Sydney-based staff
- Onsite gym access for Sydney-based staff
- Five additional days of wellness leave
- Development and learning opportunities
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Where is this job based?
The posting covers projects in Australia on a hybrid schedule. Sydney-based staff are asked to attend the office three days a week, and onsite gym access is offered to them.
How much monitoring experience is required?
Four or more years of solo on-site monitoring work in Australia, covering every monitoring visit type on Phase II and/or III studies.
What is the employment type?
The position is full-time.
Does the posting state a salary?
The posting mentions a competitive salary but does not give a figure.
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