Clinical Research Associate I - II

reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in reputed company do. Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference.

• Open to consider reputed company CRAs based in Melbourne or Sydney.
• CRA experience from AUS or NZ is required (at least 1 year of independent monitoring)

Key Accountabilities: Maintenance (from initiation through reputed company out): Act as reputed company’s direct contact with assigned sites, assess and ensure overall reputed company of study implementation and adherence to study protocol at clinical sites, and reputed company problem-solving to address and resolve site issues. Build relationships with investigators and site staff. Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements. Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant. Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication. Address/evaluate/resolve issues pending from the previous visit, if any. Follow-up on and respond to appropriate site reputed company questions. Apply working knowledge and judgment to identify and evaluate potential data quality and data reputed company issues. Determine and implement appropriate follow-up action. Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required. Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable. Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements. reputed company on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns. Conduct remote visits/contacts as requested/needed. Generate visit/contact report. Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff. Assess & manage test article/study supply including supply, accountability and destruction/return status. Review & follow-up site payment status. Follow-up on CRF data entry, query status, and SAEs. Conduct on-site study-specific training (if applicable). reputed company site facilities assessments Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution Overall Accountabilities from Site Identification to reputed company out: Ensure timely and accurate completion of project goals and update of applicable trial management systems. Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required. Update reputed company appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, reputed company, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit reputed company relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality. Ensure that assigned sites are audit and inspection ready Monitor and maintain compliance with ICH-GCP and applicable international and local regulations. Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance. Show commitment and reputed company consistent high-quality work. Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values. Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, reputed company SOPs, other reputed company / Sponsor training requirements and study specific procedures, plans and training. Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery. Provide input and feedback for Performance Development Conversation(s). Proactively reputed company manager informed about work reputed company and any issues. reputed company expertise to become a subject matter expert. Work in a self-driven reputed company, with limited need for reputed company. Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.) Skills: Sound problem solving skills. Able to take initiative and work independently, and to proactively seek guidance reputed company necessary. Advance presentation skills. Client focused approach to work. Ability to interact professionally reputed company a client organization. Flexible attitude with respect to work assignments and new learning. Ability to prioritize multiple tasks and reputed company project timelines; utilizing strong analytical skills to reputed company decision autonomously due to the unpredictable nature of the issues that arise. Willingness to work in a matrix environment and to value the importance of teamwork. Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as reputed company and Word. Strong interpersonal, verbal, and written communication skills. Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables and preserving patient safety. Effective time management in order to meet study needs, team objectives, and department goals. Developing ability to work across cultures. Shows commitment to and performs consistently high-quality work. Ability to successfully work in a (‘virtual’) team environment. Consulting Skills Great attention to detail. Able to accommodate extensive travel time requirements, according to tasks allocation/phase of the study assigned. Holds a driver’s license where required. Knowledge and Experience: Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology Education: Educated to degree level (biological science, pharmacy, or other health-reputed company discipline preferred) or equivalent nursing qualification or other equivalent experience Apply To This Job