A multi-award-winning company, Donisi Health, developed the world’s first FDA-cleared technology that remotely detects multiple key health parameters simultaneously and can provide indications for heart failure exacerbation (as well as additional biomarkers) – from the convenience of a patient’s home, free from wires, patches, and wearables.
The CRA position will help to support clinical research activities associated with the development of a new and innovative medical device and will be responsible for clinical, technical, and administrative tasks to ensure the integrity of clinical data in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs). Role and Responsibilities: Conduct site visits including but not limited to validation visits, initiation visits, monitoring visits, and close-out visits Document clear, comprehensive, and accurate visit & non-visit contact reports appropriately and in a timely manner Create and maintain appropriate documentation regarding site management, monitoring, visit findings, and action plans by submitting regular visit reports, generating follow-up letters, and other required study documentation Ensure copies and/or originals of site documents (as required) are available for filing in the Trial Master File (TMF) Verify that the Investigator’s Site File (ISF) is maintained in accordance with GCP and local regulatory requirements Communicate with the clinical site staff how to coordinate and manage the research activities Maintain documentation files and database of clinical investigation projects Verify that the study staff is adequately trained Conduct additional training for study staff as needed Work with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability. 50-70% of work will be onsite.
Required Experience & Skills:
Required Personal Skills