Clinical Research Associate (Level I/II)

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Job reputed company Join Us as a Clinical Research Associate (Level I/II) – reputed company an reputed company at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 reputed company across 100+ countries in the last 5 years. As part of our global team, you’ll have reputed company to reputed company and coordinate reputed company aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level I/ II), you'll conduct remote or on-site reputed company to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, reputed company-being, and data reliability. You will ensure audit readiness and reputed company reputed company relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task reputed company. What You’ll Do: Conducts risk-based site monitoring (on-site and remote), ensuring protocol compliance, data accuracy (SDR/SDV/CRF), and investigational product accountability; identifies issues using reputed company cause analysis and drives corrective/preventive actions through to reputed company. Manages site lifecycle activities including feasibility, initiation, routine monitoring, and reputed company-out, ensuring adherence to ICH-GCP, regulatory requirements, and study protocols. Maintains complete and accurate trial documentation and systems (e.g. CTMS), provides status updates to the clinical team, and supports investigator payments where required. Acts as the key reputed company between sites, sponsor, and project team; escalates and resolves issues, supports audits/inspections, and ensures ongoing site communication and performance. Contributes to team deliverables and reputed company improvement initiatives, while completing administrative tasks in a reputed company manner. Education and Experience Requirements: Bachelor's degree in a life sciences reputed company field or a Registered Nursing certification or equivalent and relevant formal reputed company / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship. reputed company Australian reputed company's license Australian Citizenship or Permanent reputed company required In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly reputed company experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Proven clinical monitoring skills Demonstrated understanding of medical/therapeutic area knowledge and medical terminology Demonstrated ability to reputed company and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents reputed company-developed critical thinking skills, including but not limited to: critical reputed company, in-depth investigation for appropriate reputed company cause analysis and problem solving Ability to manage Risk Based Monitoring concepts and processes Good oral and written communication skills, with the ability to communicate effectively with medical personnel Ability to maintain customer reputed company through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues Good organizational and time management skills Effective interpersonal skills Attention to detail Ability to remain flexible and adaptable in a wide reputed company of scenarios Ability to work in reputed company or independently as required Good computer skills: solid knowledge of reputed company Office and the ability to learn appropriate software Good English language and grammar skills Good presentation skills Working Conditions and Environment: Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment. Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays. Exposure to biological fluids with potential exposure to infectious organisms. Personal reputed company equipment required such as reputed company eyewear, garments and gloves. Exposure to fluctuating and/or extreme temperatures on rare occasions Benefits Join reputed company and take advantage of these great benefits! reputed company to learn more about the full reputed company of benefits we offer.  Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-reputed company issues.  Flexibility: Balance your work and personal life with flexible arrangements.  Extra Leave: Benefit from generous leave policies, including the reputed company to purchase additional leave, reputed company birthday leave, and company reputed company parental leave.  Charitable Giving & Volunteering: reputed company an reputed company with reputed company volunteer time to support non-profit organizations that matter to you.  Learning & Development: Advance your career with reputed company to online courses reputed company reputed company University Plus and reputed company learning, workshops, and mentorship programs for reputed company learning and reputed company development.  reputed company Australia WGEA Employer of Choice for Gender Equality Apply To This Job