Join Our Team as a CRAII – Helping Shape the Future of Early-Phase Research
Beyond Drug Development is a pioneering, privately owned boutique CRO headquartered in Brisbane. Operating as a fully virtual organization, we specialize in early-stage product development—driving breakthrough innovations and accelerating transformative therapies for clients worldwide. Our approach combines scientific expertise with strategic interactions with regulatory authorities, ensuring informed, efficient, and compliant pathways from concept to clinic and beyond.
Opportunity
As our organization continues to grow, we are seeking an experienced and passionate CRAII to join our Clinical Operations team. This is an exciting opportunity to work at the forefront of clinical research, contributing to projects that advance innovative therapies and shape the future of healthcare.
What We Offer:
* Flexibility that works for you: Ideally full-time, but we welcome part-time arrangements (minimum 4 days/week).
* Collaboration: Work from home while staying closely connected with a dynamic, multidisciplinary team. Role will require interstate and local travel.
* A values-driven culture: We prioritize people, ideas, and innovation. Your expertise and insights won't just be heard—they'll help shape our direction.
****Preference is for the applicant to be based in Adelaide, Sydney or Melbourne however all applicants in Australia welcome****
Why You'll Love Working Here:
* A collaborative, inclusive environment where your voice matters
* Leaders who work alongside you, committed to advancing science and supporting the team.
* A chance to be part of a respected, niche CRO that offers something truly different from larger, traditional organizations.
Clinical Research Associates (CRAs) play a vital role in ensuring our clinical research projects are executed with the quality that each client and project requires. They are the driving force of clinical operations and play a lead role in every clinical trial. Working closely with clinical sites and cross-functional teams, you'll ensure trial integrity, participant safety, and data quality across multiple sites.
What you will do
* Be responsible for managing the research activities at Australian sites (largely early phase research) including Phase 1 Units and other private/public research sites. This may require interstate travel.
* Be in communication with the medical site staff including coordinators, clinical research physicians, pharmacists and their site staff.
* Conduct site qualification, initiation, monitoring, including live monitoring and close out visits, including the training of site staff in protocol specific requirements on study protocols, procedures and regulatory requirements.
* Assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
* Perform source data verification (on-site and remote) including
* Identification and reporting of trends/emerging issues;
* Identification, reporting and follow up of SAEs (where not already identified by the sites);
* Liaises with data management to resolve data discrepancies and ensure all data clean;
* Prepares accurate and timely visit reports for all types of visits.
* Support Project Manager and other team members as required.
* Assist in the tracking and distribution of study documents, safety reports, non-clinical and clinical trial materials.
* Assist in the overall tracking of project milestones through various software applications (e.g., Microsoft Excel tracking tools).
* Attend project team meetings.
* Assist in the production and delivery of presentations, etc., as needed for project, departmental, sponsor and/or business development presentations.
* Conduct feasibilities to determine appropriate site selection/identification for clinical trials. This may include the development of feasibility tools such as a communication tracking log, feasibility questionnaire and support in developing feasibility reports.
* Supporting site readiness for audits and inspections.
* Support Clinical Project Managers and other team members as required.
* Contributing to training and mentoring of junior CRAs.
* Other duties as assigned.
Competencies/Experience/Qualifications
* At least 2-4 years of CRA experience in either biotech, pharma or CRO companies with a strong understanding of clinical trial processes is essential.
* A degree in life sciences or equivalent.
* Advanced understanding of clinical trial management, ICH-GCP and Australian regulatory requirements.
* Excellent interpersonal, oral, and written communication skills in English.
* Exceptional organisational skills with attention to detail.
* Plan, manage, and prioritize workloads and tasks effectively to ensure the achievement of key study milestones within the established timelines and quality standards.
* Works independently or with minimal supervision.
* Managing more complex trials or a greater number of study sites.
* Proficiency in Microsoft Office, CTMS, eTMF and EDC Systems.
* Strong attention to detail and focus on quality of work.
* Strong organisational and problem-solving skills.
Beyond Drug Development / BDD