Senior Clinical Research Associate

As a Senior CRA at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications maintaining the highest quality standards in the industry.

Location: Macquarie Park NSW

You will:

• Prepare conduct and report site selection initiation routine monitoring and close-out visits
• Act as the main line of communication between project team Sponsor and the site
• Ensure that subject recruitment targets and project timelines are met at site level
• Perform CRF review source document verification drug accountability and query resolution
• Facilitate the flow of site documents assist in maintaining study-specific and corporate tracking systems
• Support Study Startup and Regulatory teams in preparation of draft regulatory and ethics committee submission packages 
• Conduct project-specific training of Investigators prepare Investigator newsletters
• Participate in study site audits and client onsite visits as required
• Monitor project timelines and patient enrollment implements respective corrective and preventive measures
• Support junior Monitors in the query resolution process including Central Monitoring observation
• Coordinate safety information flow and protocol/process deviation reporting
• Perform clinical supplies management with vendors
• Support site contracting and payments
• May lead project team calls on a country level

Qualifications :

• College/University degree in Life Sciences Pharmacy RN or an equivalent combination of education training & experience
• At least 5 years of independent on-site monitoring experience or an equivalent experience
• Experience in all types of monitoring visits in Phase II and/or III
• Experience in feasibility assessment and study set-up process is preferable
• Experience in Oncology or Hematology therapeutic indications is a plus (preferable)
• PC skills to be able to work with MS Word Excel and PowerPoint
• Ability to plan multitask and work in a dynamic team environment
• Communication collaboration and problem-solving skills
• Ability to travel

Additional Information :

What youll get:

• Competitive salary
• We offer hybrid work arrangement - 2 days flexi and 3 days in office
• Access to a wide range of employee benefits
• Additional 5 days of wellness leave
• Development and learning opportunities
• Chance to make a real impact in a meaningful industry

About Us

PSI is a passionate organically grown and award-winning full-service CRO who dares to be different. As a dynamic and global company we bring together more than 3000 driven and dedicated experts across 60 countries working collectively to help make a positive impact on patient lives.  

How are we different

PSI is privately owned by the very people who founded the company 30 years ago and theyre still working here today. As a result we have grown organically around the globe and have kept our company fully independent giving us significant advantages and freedoms.  

Being a Part of the Team

As a part of the PSI team you will have a fair degree of ownership and autonomy to make nuanced country-and department-specific adjustments while nurturing the global PSI culture that unites us across six continents.

You will receive continuous support from your global peers and join a fast-paced innovative and results-oriented working environment with lean communication lines. We pride ourselves on being approachable receptive to new ideas and open to feedback.

Growth Opportunities

PSI is proud to invest in our people from entry-level team members to senior leaders helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs our professionals have a variety of opportunities to continue to grow throughout their career.

Remote Work :

No

Employment Type :

Full-time