About Us
Southern Star Research is a full-service Contract Research Organization (CRO) dedicated to navigating the complexities of bringing new medical products to market. With a legacy of excellence that began 14 years ago in Sydney, we have grown from a small, passionate team into a global network of experts committed to delivering high-quality services in medical writing, clinical monitoring, project management, biostatistics, data management, safety and medical monitoring, and quality assurance. Southern Star Research has been recognized for its outstanding contributions to the field, winning prestigious awards such as the Frost and Sullivan 2024 Asia-Pacific Competitive Strategy Leadership Award and being named as Great Place to Work in Australia in 2024 and 2025. Our international team continues to deliver innovative clinical trial solutions across diverse therapeutic areas, ensuring the success of every study we manage.
Due to ongoing growth, we are looking for an experienced CRA to join our team, ideally based in Sydney or Melbourne. Other locations are also fine but will require regular interstate travel. We are open to candidates at CRA II or Senior CRA level.
About The Role
Reporting to the Senior Clinical Team Leader, you'll be responsible for:
* Conducting site qualification, interim monitoring and study closeout visits;
* Conduct all clinical site activities according to the monitoring plan and in accordance with the study timelines;
* Act as a central point of contact at investigator meetings and site initiation visits;
* Manage all aspects of the clinical monitoring process;
* Build and develop relationships with site stakeholders;
* Identify, evaluate and recommend new potential investigators and sites on an ongoing basis;
* Mentoring of junior Clinical Research Associate's.
To be successful in the role, we're looking for candidates with:
* A minimum of 5 years experience in clinical research and 2 years of independent monitoring experience for a SCRA or a minimum of 1 year of independent monitoring for a CRA;
* A solid understanding and knowledge of appropriate therapeutic indications as they relate to the conduct of clinical trials;
* A sound knowledge and understanding of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations;
* Strong planning and organisational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines;
* Exceptional communication skills as well as strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated;
* Demonstrated business ethics and integrity.
* Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines
Why Southern Star Research?
* Competitive remuneration
* Flexible work environment, with hybrid and fully remote options
* Ongoing opportunities for learning and development
* Company growth creating exciting opportunities to develop your career
* STAR day - one extra day off per year for you to recharge
* Join a purpose driven organisation contributing to brighter futures, one study at a time
Diversity, Equity and Inclusion
At Southern Star Research, we are committed to fostering a safe, inclusive, and respectful workplace where everyone feels valued and empowered to contribute. We celebrate the diversity of our team and recognise the strength that comes from different perspectives, backgrounds, and lived experiences. We are dedicated to ensuring an inclusive recruitment process and providing equal opportunities for all applicants, regardless of race, ethnicity, gender identity, sexual orientation, age, disability, or cultural background.
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