Clinical Research AssociatePosition Title: Clinical Research Associate (CRA)Location: Must be Perth BasedEmployment Type: Part Time employed 2-3 days a weekAbout the RoleAvion are an Australian owned, boutique, end-to-end full-service specialist CRO services provider aimed at supporting biotechnology, pharmaceutical, medical technology and device companies to undertake their clinical development programs both in Australia and around the world.
Our aim is to innovate today to transform tomorrow's healthcare to provide better patient outcomes.
have an exciting opportunity to join our dynamic and collaborative clinical research team and are currently seeking a highly experienced and motivated Clinical Research Associate (CRA) with a strong background in radiopharmaceuticals.
In this role, you will oversee the planning, execution and monitoring of clinical trials to ensure compliance with regulatory requirements, ICH/GCP guidelines and study protocols.
You will manage all aspects of studies at a site level and ensure that project documentation is managed timely and in a compliant manner.
You may provide guidance to other research staff or assist with PM related tasks.
You will work closely with cross-functional teams, investigators and external vendors to ensure the successful delivery of clinical trials involving radiopharmaceutical products.Key ResponsibilitiesStudy Oversight and Execution:Lead the execution of early phase clinical trials with a focus on radiopharmaceuticals.Coordinate and monitor trial activities at clinical sites to ensure adherence to protocols, timelines and quality standards.Support feasibility, site selection and start-up activities, including leading the preparation of HREC submissions with sites.Regulatory Compliance:Ensure compliance with GCP, FDA, EMA, ICH guidelines and other applicable regulations.Maintain thorough documentation to support regulatory submissions.Site Management:Serve as the primary point of contact for clinical sites, investigators and study coordinators.Establish regular lines of communication and administer protocol and related study training to assigned sites.Conduct site qualification, initiation, monitoring and close-out visits to assess site performance and compliance.Negotiate site budgets and assist with the execution of site contracts and site payments with support from the PM.Data Management:Review and verify clinical trial data for accuracy, completeness and consistency.Maintain eTMF filing and study tracking in CTMS in a timely manner.Collaborate with data management teams to address data queries and ensure timely database lock.Risk Assessment and Problem Solving:Proactively identify potential risks and issues in trial conduct and implement mitigation strategies.Troubleshoot operational challenges in collaboration with cross-functional teams.Training and Mentorship:Provide training and mentorship to junior CRAs and clinical site staff.Contribute to the development of training materials and operational guidelines.QualificationsEducation:Bachelor's degree in Life Sciences, Pharmacy, Nursing or a related field (advanced degree preferred).
Experience:Minimum of 2-3 years of experience in clinical research with experience in radiopharmaceutical trials highly preferred.Experience in managing early phase oncology trials.Experience in all aspects of site-management from feasibility, start-up, site selection to site close-out.Experience in HREC submissions and contract negotiations desirable.In-depth knowledge of clinical development processes, preferably including radiopharmaceutical safety and imaging modalities (e.g., PET, SPECT).
Technical Skills:Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
Familiarity with radiopharmaceutical handling, dosing and safety protocols desirable.Understanding and practical knowledge of ICH-GCP requirements as required for site management.Soft Skills:Strong organizational, communication and interpersonal skills.Ability to work independently and manage multiple priorities effectively.Ability to establish and maintain effective working relationships with colleagues, managers and customers.Willingness to travel to fulfill the requirements of the role.Why Join Avion?
Opportunity to contribute to cutting-edge research in oncology and radiopharmaceuticals.Opportunity to work across the entire spectrum of the clinical trial life cycle and to work directly with sponsors on some projects.Collaborative and innovative work environment.Competitive compensation and benefits package.Opportunities for professional growth and development.
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