Clinical Safety Associate

The Clinical Safety Associate performs safety reporting and trial submissions to Ethics Committees and Regulatory Authorities according to the relevant legislation and guidelines for clinical trials with medical devices under the supervision of the Clinical Safety/Regulatory Affairs Manager.

Objective of the job

  • Processing of reportable events from designated clinical trials, including initial review, triage, narrative writing and tracking
  • Performing safety reporting for clinical trials in compliance with the relevant reporting requirements;
  • Assisting in preparation, conduct and follow up of safety meetings (eg. Data Safety Monitoring Board and Clinical Event Committee meetings);
  • Involvement in submission and writing of the periodic safety reports;
  • To collect, prepare (eg. Application forms; Patient Informed Consent Forms,…) and ensure timely filing of study documents to ethics committees and authorities;
  • To communicate with clinical investigation sites and Ethics Committees;
  • To report on the activities in a timely fashion to the Regulatory Affairs Manager/Clinical Safety Manager;
  • To ensure that regulatory submission and safety tracking systems/databases remain updated

The candidate has excellent planning and organizational skills with proven time-management skills. He/She is proficient in MS Office, detail-oriented and pro-active with a strong analytical mind. The candidate is fluent in English.

Required experience
Starter position - Relevant experience in clinical research, hands-on experience preparing, reviewing, and submitting regulatory documentation/safety events, is preferred.

Required education
Higher educational degree (MSc) in a medical or science-related field

We are looking for a Clinical Safety Associate in New York or Cleveland, USA.

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