Clinical Research Associate - EU

at  Endotronix Inc

WHO ARE WE?

Endotronix is a medical device company that aims to transform the treatment of heart failure, a chronic, progressive condition in which the heart is unable to pump enough blood to support the body. Our Cordella Heart Failure System (CHFS) includes proactive management tools for best practice care and detection of worsening heart failure. These easy-to-use tools improve patient quality of life and help to reduce hospital admissions thereby reducing health care costs.

EDUCATION

• Bachelor’s Degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology).

The Clinical Research Associate II will take part in all areas of clinical trial management in Europe. This includes, but is not limited to, day-to-day activities such as trial start-up, conduct, and closeout activities as well as supporting a range of activities on large multi-center studies, management of vendors and management of investigative sites with the support of Endotronix Director of Clinical Operations. Although this is a remote position, you must be located in Ireland, Germany or The Netherlands. Your responsibilities will include:

• Participate in the management of the completion of routine trial start-up, conduct, and close-out activities to industry and corporate standards, with support from the Director of Clinical Operations
• Evaluate and select investigative sites
• Site monitoring responsibilities for Clinical trials, according to Endotronix Standard Operating Procedures, ISO, ICH and GCP Guidelines, including Pre-study, Site Initiation, Routine Monitoring and Close-out visits.
• Manage some aspects of trial operations including internal metrics, and communication of trial status within and outside the trial team
• Ensure that assigned clinical trial tasks are conducted in accordance with the protocol, country regulations, Good Clinical Practice regulations, ISO 14155 and internal Standard Operating Procedures
• Follow up and implement clinical site contracts and budgets
• Involvement in various tasks to support the Study Team/Management with any trial related activities in all phases of the conduct of the clinical trial
• Prepare study specific tools (including communication tools such as newsletters, flyers etc.)
• Manage trial specific TMF (setup, maintain, archival) including, as/if appropriate, site regulatory document and legal document tracking and archiving throughout the duration of the clinical trial in accordance with SOPs, ISO 14155, GCP and ICH guidelines
• Manage all study-related supplies
• Assist with the writing and review of clinical documents such as informed consents, trial reports, and annual reports
• Assist with the organization and participate in investigational meetings and site training representing assigned clinical trial
• Perform co-monitoring visits as required