• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance • Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate • Demonstrates diligence in protecting the confidentiality of each subject/patient • Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues • Conducts Source Document Review of appropriate site source documents and medical records • Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records • Applies query resolution techniques remotely and on-site • Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture • Verifies site compliance with electronic data capture requirements • Supports subject/patient recruitment, retention and awareness strategies

• Oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards • Lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement • Monitor clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards • Conduct site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution • Collaborate with cross-functional teams to ensure timely and accurate data collection and reporting • Provide training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct • Build and maintain effective relationships with site personnel and stakeholders to facilitate smooth trial operations

Role Description - Design questions related to the Registered Nurse occupation using your professional experience. - Collaborate with one of the world’s top AI companies to enhance project outcomes. - Ensure high-quality content by leveraging domain expertise in nursing. - Work independently and asynchronously to meet project deadlines. - Utilize a desktop or laptop computer for project tasks. Qualifications - 4+ years full-time work experience as a Registered Nurse. - Be based in the US, UK, or Canada. Requirements - Hourly contractor with competitive rates based on background and location. Benefits - For details about the interview process and platform information, please check: here . - For any help or support, reach out to: support@mercor.com . - Our team reviews applications daily. Please complete your AI interview and application steps to be considered for this opportunity.

Role Description When our values align, there's no limit to what we can achieve. At Parexel, we all 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 what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. - Open to consider experienced CRAs based in Melbourne or Sydney. - CRA experience from AUS or NZ is required (at least 1 year of independent monitoring). Key Accountabilities: - Act as Parexel’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform 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. - Follow-up on and respond to appropriate site related questions. - Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity 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. - Perform 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). - Perform 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 Close 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 all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all 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 perform 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, Parexel SOPs, other Parexel / 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 keep manager informed about work progress and any issues. - Develop expertise to become a subject matter expert. - Work in a self-driven capacity, with limited need for oversight. - Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.). Qualifications - Sound problem solving skills. - Able to take initiative and work independently, and to proactively seek guidance when necessary. - Advance presentation skills. - Client focused approach to work. - Ability to interact professionally within a client organization. - Flexible attitude with respect to work assignments and new learning. - Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make 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 Excel 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-related discipline preferred) or equivalent nursing qualification or other equivalent experience.