Bring your monitoring expertise to the forefront of innovation. We are looking for a Sr Clinical Research Associate (SrCRA) to join our A-team (hybrid). As a CRA at Allucent, you will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice.
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. At Allucent we are big enough to deliver and small enough to care. We know all our colleagues by name and work together as a team to make everyone SHINE.
Requirements
As a SrCRA, you will take the lead on monitoring activities on the East Coast of Australia, owning your sites and relationships with investigators. You’ll be the bridge between sponsor and site, ensuring trial integrity while being supported by a collaborative, experienced team. This includes work related to regulatory affairs, site activation processes—including contracting and start-up activities—to ensure smooth and compliant study execution.
Main responsibilities:
- Independently manage all aspects of monitoring for assigned clinical trials across study phases, including site initiation, routine monitoring, and close-out visits.
- Ensure compliance with protocols, GCP, ICH, SOPs, and applicable regulatory requirements.
- Build strong site relationships, acting as a primary point of contact and ensuring high-quality data collection.
- Identify and resolve site issues, escalating as needed to maintain trial integrity and patient safety.
- Activities around regulatory affairs, site activation and study-startup.
Who are we looking for:
You’re an experienced SrCRA ready to take the next step with a company that truly values your expertise and independence. You thrive in an agile, collaborative environment and want to be part of a team making a real impact.
- Experience leading Onsite activities in complex trials, with a minimum of at least 7 years’ onsite monitoring experience in Australia.
- Strong understanding of ICH-GCP and regulatory guidelines.
- Clear and confident communicator in English.
- Comfortable working independently and managing priorities.
- Willingness to travel, as required.
Benefits
About Allucent
At Allucent, our mission is to shine a light on new therapies that improve lives. When you join our team, you’ll use your unique skills, expertise, and knowledge to forge meaningful partnerships with clients while helping them turn groundbreaking ideas into life-changing treatments.
If you’re passionate about advancing pharmaceuticals and biologics, fueled by an entrepreneurial spirit, and eager to collaborate with top minds across science, business, and operations, we’d love to connect. Together we can accelerate innovation and grow side by side, making a last impact on patients worldwide.
Together we SHINE. Find more information about our values.
Skills Required
- Minimum of at least 2 years onsite monitoring experience
- Experience leading onsite activities in complex trials (site initiation, routine monitoring, close-out)
- Strong understanding of ICH-GCP and applicable regulatory guidelines
- Experience with regulatory affairs, site activation and study start-up including contracting
- Clear and confident communicator in English
- Comfortable working independently and managing priorities
- Willingness to travel as required
- Experience in oncology or rare disease trials
What We Do
Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. The company is purpose-built through the convergence of leading providers to address this unmet need. Today, Allucent is a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients.
