Medpace

Title: Clinical Research Associate Entry Location: South Yarra, Melbourne Australia Job Description: Job Summary What can Medpace offer you? - Full-time employment and office-based - Dynamic working environment, with varying responsibilities day-to-day - Expansive experience in multiple therapeutic areas - Work within a team of therapeutic and regulatory experts - Defined CRA promotion and growth ladder with potential for mentoring and management advancements - Competitive transportation allowance - Annual Merit increases - Variable Compensation Bonus Plan - Lucrative bonus calculated directly from the number of visits you do - MEDPACE CRA TRAINING PROGRAM (PACE) No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs. Through our PACE Training Program, you will join other Professionals Achieving CRA Excellence: - PACEprovides the platform to effectively and confidently carry out your duties, enhance your current abilities and ultimately help you become a high-functioning independent Medpace CRA. - PACEwill prepare you by developing your CRA skills through interactive discussions and hands on job-related exercises and practicums. - To supplement your in-house and field-based training you may also participate in other clinical research departmental core rotations, learning other aspects of the drug/device development and approval process. - No metric for minimum required days on site per month. - Airline club allowance - Casual Dress Code Responsibilities - Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol; - Communication with the medical site staff including coordinators, clinical research physicians and their site staff; - Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff; - Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements; - Verification that the investigator is enrolling only eligible subjects; - Regulatory document review; - Investigational product/drug accountability and inventory; - Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol; - Assessing the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and - Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance. Qualifications - Bachelor's degree in a health or science related field; - Prior 1 year of study coordinator experience is preferred; - Willing to travel approximately 60-80% to locations nationwide is required, or less if remote/virtual visits; - Strong communication and presentation skills; and - Must be detail-oriented and efficient in time management. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks - Flexible work environment - Competitive compensation and benefits package - Competitive PTO packages - Structured career paths with opportunities for professional growth - Company-sponsored employee appreciation events - Employee health and wellness initiatives Awards - Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 - Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

• Communicate and collaborate on global study activities; working closely with the project coordinator and clinical trial manager • Ensure timely delivery of recurrent tasks consistently with a high degree of accuracy • Compile and maintain project-specific status reports within the clinical trial management system • Interact with the internal project team, Sponsor, study sites, and third-party vendors • Provide oversight and quality control of our internal regulatory filing system • Provide oversight and management of study supplies • Create and maintain project timelines • Coordinate project meetings and produce quality minutes

• Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;• Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;• Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;• Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;• On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;• Verification that the investigator is enrolling only eligible subjects;• Regulatory document review;• Medical device and/or investigational product/drug accountability and inventory;• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;• Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement;• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

• Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol • Communication with the medical site staff including coordinators, clinical research physicians and their site staff • Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff • Medical record and research source documentation verification against case report form data • Ensuring good documentation practices are adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements • Verification that the investigator is enrolling only eligible subjects • Regulatory document review • Medical device and/or investigational product/drug accountability and inventory • Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol • Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement • Completion of monitoring reports and follow-up letters, summarizing significant findings, deviations, deficiencies, and recommended actions to secure compliance

• Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol • Communication with the medical site staff including coordinators, clinical research physicians and their site staff • Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff • Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements • Verification that the investigator is enrolling only eligible subjects • Regulatory document review • Medical device and/or investigational product/drug accountability and inventory • Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol • Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement • Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance

• To perform close follow up of Clinical Trials submitted to Drugs Controller General of India (DCGI), Face to face visits expected. • Facilitate meetings with DCGI, support consultation processes when needed. • Efficiently manage and successfully execute all aspects of local and Regional APAC start-up; • Independently interact with Sponsor, sites, Institutional Review Boards (IRBs)/Ethics Committees (ECs) and regulatory agencies (minimum CDSCO and DCGI). • Perform quality checks on submission documents and site essential documents; • Prepare and approve informed consent forms; • Review pertinent regulations to develop proactive solutions to start-up issues and challenges; • Present during bid defenses, general capabilities meetings, and audits.