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Experienced Clinical Research Associate (Home-Based)
MedpaceWorkFromHome, Auckland, New Zealand30+ days ago
Job descriptionConduct 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; Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance. Bachelor's degree in a health or science related field and with at least 2 to 5 years of experience in clinical monitoring; Knowledgeable about Clinical Monitoring practices and procedures to represent the function in internal and external (e.g., business development) meetings. 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 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 Bachelor's degree in a health or science related field and with at least 2 to 5 years of experience in clinical monitoring; Knowledgeable about Clinical Monitoring practices and procedures to represent the function in internal and external (e.g., business development) meetings. 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; Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
What can Medpace offer you?
- Flexible working conditions – Opportunity to work from home and flexible working hours
- Visa sponsorship & transfer for qualified candidates already based in New Zealand
- Annual Merit increases
- Variable Compensation Bonus Plan – Lucrative bonus calculated directly from the number of visits you do
- Fast PACE – Accelerated, tailored training program training program based on your experience
- No metric for minimum required days on site per month.
- Opportunity for cross-functional and CRA leadership positions – Lead CRA, CRA Manager, Clinical Trial Manager
- Airline club allowance
- Casual Dress Code
Responsibilities
Qualifications
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 5,000 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
Awards
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
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