Clinical Research Associate II

Psicro; Sydney; Hybrid; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Onsite Gym access

Wellness leave

Development opportunities

Job summary

PSI is a dynamic, global CRO seeking a knowledgeable CRA II to manage the clinical aspects of full-service global projects in Australia. You will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications.

You will build and maintain relationships with clinical sites and investigators. You will focus on subjects' rights, safety, and data quality compliance, travel as required,

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, RN or equivalent.
• Minimum 2 years on-site monitoring experience in Australia.
• Experience in Phase II/III monitoring.
• Must be able to travel and work across sites.
• Fluent English communication required.
• Proficient in MS Word, Excel and PowerPoint.

Responsibilities

• Conduct and report all types of on-site monitoring visits.
• Be involved in study startup and regulatory support.
• Perform CRF review, source data verification and query resolution.
• Facilitate site budgets and contract negotiations.
• Monitor trial progress at country level and manage site communication.
• Serve as liaison with in-house teams and vendors.

Skills

Travel willingness

Communication skills

Team collaboration

On-site monitoring experience

Education

Bachelor's degree Life Sciences/Pharmacy/RN

Tools

MS Word

Excel

PowerPoint

Job description

We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

PSI's business is about conducting clinical research of novel medications. We work at the interface of R&D, pharmaceutical industry and healthcare science and provide services to big and mid-sized pharmaceutical companies. We help our clients to generate data about safety and efficacy of medications and bring the best ones to market. By conducting global clinical research trials, PSI makes cutting-edge treatment available in drugstores all over the world and helps patients with serious medical conditions to improve or even save their life. Help us to make sure that PSI medical and business documents are clear to patients, physicians, regulatory authorities, and clients.

We offer an inspiring story of the company that has grown organically from a handful of countries to global presence. PSI is a mature company with standards and practices, but we do not stand still. Every day, there is a figurative Everest to climb, and you will not get bored here.

Job Description

We’re searching for a knowledgeable, team-oriented CRA II to manage the clinical aspects of full-service globalprojects in Australia. As a CRA II at PSI, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. You will focus on subjects' rights, safety and well-being and quality of data compliance.

You will:

• Conduct and report all types of onsite monitoring visits
• Be involved in study startup
• Perform CRF review, source document verification and query resolution
• Facilitatesite budgets and contract negotiations
• Monitor trial progress on the country level
• Be responsible for site communication and management
• Be a point of contact for in-house support services and vendors
• Communicate with internal project teams regarding study progress
• Participate in feasibility research
• Support regulatory team in preparing documents for study submissions

Qualifications

• College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
• At least 2 years of independent on-site monitoring experience in Australia
• Experience in all types of monitoring visits in Phase II and/or III
• Experience inInflammatory Bowel Disease, Oncology, Infectious Diseases is a plus
• Full working proficiency in English
• 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 you’ll get:

• We offer hybrid work arrangement - 2 days flexi and 3 days in office
• Access to a wide range of employee benefits such as onsite Gym access
• 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 they're 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.

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.