div class="flex max-w-full flex-col grow">Subject Matter Expert: Legal & Regulatory Research (Remote Advisory).
We've built a unique platform that connects researchers and companies with a global pool of participants, enabling the collection of high-quality, ethically sourced human behavioural data and feedback.
div class="flex max-w-full flex-col grow">Senior Finance Consultant: Corporate Strategy & Research (Remote Advisory).
We've built a unique platform that connects researchers and companies with a global pool of participants, enabling the collection of high-quality, ethically sourced human behavioural data and feedback.
p>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; 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. Flexible work environment Competitive PTO packages - starting at 20+ days Company-sponsored employee appreciation events Employee health and wellness initiatives Competitive compensation and benefits package Structured career paths with opportunities for professional growth Discounts for local businesses Awards Named a Top Workplace in 2024 by The Cincinnati Enquirer Recognized by Forbes as one of Americas 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.
Responsibilities : 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; and. Qualifications : Must have a minimum of a Bachelor’s degree in a health or science related field; Experience as a Clinical Research Coordinator (minimum 1 year); Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely; Must maintain a valid driver’s license and the ability to drive to monitoring sites; Proficient knowledge of Microsoft® Office; Strong communication and presentation skills; and.
CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.
Utilize data to track the performance and effectiveness of the IntelliSep solution in improving clinical outcomes, operational efficiency, and financial performance, and provide insights into customer-related metrics and the potential impact on patient outcomes and hospital reimbursement. The role will encompass data analysis and curation from multiple large clinical datasets to inform internal reports, external presentations, manuscripts, and publications, and to inform future clinical trial design.