Clinical Research Associate
Location
Australia
Posted
5 days ago
Salary
0
Seniority
Mid Level
Job Description
Clinical Research Associate
Emerald Clinical
• Coordinate the identification, feasibility assessment, and selection of investigators and sites to undertake the trial. • Complete all monitoring activities per the Monitoring Plan along with completing monitoring visit reports, accurately and within the predetermined timeframe. • Prepare, plan, organize, and conduct site evaluation visits and report on these visits to assist in site selection. • Prepare, submit, and/or liaise with regulatory specialist colleagues, regarding the preparation of regulatory packages, importation/exportation requirements, and updates of Ethics Committee packages. • Negotiate site budgets, coordinate for site contract execution, track invoicing, and ensure timely site payments. • Prepare, plan, organize, and conduct site initiation visits. • Develop and maintain appropriate monitoring tools and project-specific documents. • Motivate and train investigators to ensure that the trial site personnel have a good understanding of the protocol, investigational product, and requirements of the trial so they can fulfill their obligations to conduct the trial accurately and to deadlines. • Collect, review, and approve essential documents from trial sites, to ensure quality and compliance, and code documents for Trial Master File (TMF) filing. • Reconcile contents of in-house TMF and site’s Investigator Site Files. • Coordinate distribution, tracking, handling, and destruction of investigational product and other trial supplies per site/trial requirements. • Maintain trial information using the clinical trial management system and any other tracking and reporting tools for the trial. • Support strategies to boost recruitment efforts.
Job Requirements
- Tertiary qualifications in a related science or health care discipline.
- Previous experience in clinical trials within an academic, CRO, or pharmaceutical environment with 2-5 experiences in on-site monitoring and site management experience is mandatory.
- Experience in Oncology and/or early-phase clinical trials is a plus.
- Demonstrate practical knowledge of ICH-GCP guidelines and global and local ethical and regulatory research requirements.
- Display competence in the following technical areas: ethical and participant safety considerations, site start-up management, site conduct management, risk management, quality management, supply management, scientific concepts and clinical research design, and issue escalation management.
- Demonstrate competence in the following business skill areas: negotiation and conflict resolution, critical thinking, problem-solving, decision making, and strategic thinking.
- Demonstrate solid interpersonal communication, presentation skills, and flexibility to work well within a multi-disciplinary team both autonomously and with a wide range of varying stakeholders.
- Ability to be flexible and adaptable in the face of changing organizational priorities and ambiguous environments.
- Ability and willingness to travel.
Benefits
- Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience.
- Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role.
- Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.
- Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.
- Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients.
Related Guides
Related Categories
Related Job Pages
More Research Analyst Jobs
Title: Senior Business Analyst - Medicaid Location: Any city, DC, US, 99999 Req ID: 36786 Work Mode: Virtual (Exception only) Job Description: Great companies need great teams to propel their operations. Join the group that solves business challenges and enhances the way we work and grow. Working at Gainwell carries its rewards. You'll have an incredible opportunity to grow your career in a company that values your contributions and puts a premium on work flexibility, learning, and career development. Summary As a Senior Business Analyst - Medicaid at Gainwell, you will apply your analytical expertise to help harness the power of data and technology in support of our mission: improving the health and well‑being of the vulnerable populations our clients serve. Bring your passion and purpose to a team that thrives on solving some of healthcare's most complex challenges. You will serve as a partner and thought leader in transforming data into actionable insights that enhance operational efficiency and effectiveness. While grounded in quantitative analysis, you will also understand the operational realities and complexities that shape how data is applied. Your role in our mission You will play a critical role in ensuring Gainwell meets key client objectives across essential operational areas. - Serve as a lead analyst for complex, multi‑system claims and financial processing activities within Gainwell's DC Medicaid program. - Develop a deep understanding of end‑to‑end medical claims and financial processes, including daily, weekly, and monthly operational cycles. Use this knowledge to evaluate data, confirm systems are performing within expected parameters, and identify processing issues when they arise. - Understand contact center workflows, tools, performance metrics, and SLA requirements. Analyze data to identify adverse trends, anomalies, and opportunities for improvement. - Partner closely with supervisors and managers to support operational data analysis, including querying datasets to assist with performance improvement initiatives and special projects. - Analyze, design, document, and recommend enhancements to business processes that support operational effectiveness. - Apply analytical and relational database tools - such as Excel, Access, and SQL - to quantify trends, assess impacts, and uncover anomalies. - Collaborate with other Business Analysts across multiple functional areas and solution components. - Engage directly with state client stakeholders (DHCF) on data‑related issues when needed. What were looking for - 6+ years of experience as a Business Analyst in the Healthcare Industry; 3+ years of Medicaid or Medicare experience preferred. - Understanding of computer programming concepts, including configuration, development, and batch processing. - Advanced proficiency with analytical tools such as Microsoft Excel, Access, SQL, and requirement‑mapping tools such as ALM platforms. - Strong client‑facing communication skills with the ability to translate client needs into actionable objectives. - Strong analytical and business process re‑engineering capabilities. - Executive presence and the ability to communicate effectively with business leaders, clients, and technical teams. What you should expect in this role - Remote work environment with occasional travel to Washington, DC or other Gainwell locations as needed. - Residency and work location must be within the contiguous United States (48 states). - Video cameras are required to be on for all interviews and meetings, both internal and client‑facing. - Standard working hours are 8:00 AM - 5:00 PM EST. - Flexibility to work outside normal business hours when necessary to support critical processes or remediation efforts. - This posting is intended for pipelining. This is a developing position therefore the job description is subject to change. #LI-HC1 #LI-End to End Medical Claims #LI-Contact Center Workflows The pay range for this position is $69,400 - $99,200 per year, however, the base pay offered may vary depending on geographic region, internal equity, job-related knowledge, skills, and experience among other factors. Put your passion to work at Gainwell. You'll have the opportunity to grow your career in a company that values work flexibility, learning, and career development. All salaried, full-time candidates are eligible for our generous, flexible vacation policy, a 401(k) employer match, comprehensive health benefits, and educational assistance. We also have a variety of leadership and technical development academies to help build your skills and capabilities. We believe nothing is impossible when you bring together people who care deeply about making healthcare work better for everyone. Build your career with Gainwell, an industry leader. You'll be joining a company where collaboration, innovation, and inclusion fuel our growth. Learn more about Gainwell at our company website and visit our Careers site for all available job role openings. Gainwell Technologies is an Equal Opportunity Employer, where all qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical condition), age, sexual orientation, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Gainwell Technologies defines "wages" and "wage rates" to include "all forms of pay, including, but not limited to, salary, overtime pay, bonuses, stock, stock options, profit sharing and bonus plans, life insurance, vacation and holiday pay, cleaning or gasoline allowances, hotel accommodations, reimbursement for travel expenses, and benefits.
Industry Insights Analyst – Editorial Lead
NearaIntelligence for infrastructure ⎮ Register for our upcoming webinar: bit.ly/447oixq
• Imagine, scope, and lead research projects that bring different facets of grid resilience and the energy transition to life using public and external data. • Generate hypotheses, rapidly test them against credible external sources, and proactively surface the most interesting findings before anyone's asking for them. • Turn analysis into evidence-led, implication-focused editorial in a range of formats, including reports, blogs, briefings, executive-ready narratives, and campaign content, that are naturally aligned to Neara's strengths without a promotional tone. • Act as an internal thought partner to leaders across Sales, Product, and the executive team, helping them interpret industry shifts, sharpen their arguments, and translate insight into how they think, plan, and communicate. • Define and track the key resilience and infrastructure metrics that become Neara's recurring, ownable point of view on the state of the grid, a benchmark the industry watches, built entirely on defensible public evidence. • Detect and interpret industry inflection points by synthesizing policy, market, social, and technical signals, then translate what changed, why it matters, where Neara fits, and how executive thinking should adjust. • Equip customer-facing teams with forwardable, data-backed perspectives and executive-level language that strengthen credibility and move strategic deals. • Publish internally and externally, and engage reporters as a trusted, evidence-grounded source to help shape industry storylines. • Safeguard Neara's point of view by stress-testing positioning against real market sentiment, challenging internal assumptions, and making sure every claim is credible, earned, and defensible.
• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials • Ensuring protocol compliance, data integrity, and patient safety throughout the trial process • Collaborating with investigators and site staff to facilitate smooth study conduct • Performing data review and resolution of queries to maintain high-quality clinical data • Contributing to the preparation and review of study documentation, including protocols and clinical study reports
• Serve as the primary point of contact between investigation sites and the sponsor for early development multi therapeutic clinical trials. • Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out • Ensure site compliance with ICH-GCP, SOPs, and regulations • Maintain up-to-date documentation in CTMS and eTMF systems • Support and track site staff training and maintain compliance records • Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting • Support subject recruitment and retention efforts at the site level • Oversee drug accountability and ensure proper storage, return, or destruction • Resolve data queries and drive timely, high-quality data entry • Document site progress and escalate risks or issues to the clinical team • Assist in tracking site budgets and ensuring timely site payments (as applicable) • Collaborate with cross-functional partners including CTAs, LTMs, and CTMs


