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Form of work
SalaryWe are seeking a Clinical Research Associate to join our growing team. Primary responsibilities include assisting the Safety Managerto ensure appropriate reporting of adverse events and product experiences reported. The Clinical Safety Associate assists with ensuring accurate and timely documentation. The Clinical Safety Associate also assists the Safety Manager who acts as a liaison between internal stakeholders as well as to external customers such as CROs, Clinical Events Committees and Data Safety Monitoring Boards associated to the trial.
MAJOR DUTIES AND RESPONSIBILITIES:
· Assist with all activities related to establishing and managing all safety-related processes as directed by the Safety manger to include:
o Participate in the fcreation of case report forms used to report and manage the tracking of adverse events.
o Support preparation of safety section of clinical study reports, Clinical Expert reviews, clinical section of device reports, and other report documents as needed to support regulatory filings to US and International regulatory bodies.
o Review clinical safety databases for adverse events and device deficiencies and compose safety narrative reports.
o Assist sites with subject evaluation and protocol adherence for adverse event reporting timelines.
o Assist managing Clinical Events Committee (CEC), Data and Safety Monitoring Board (DSMB) and Safety outsource activities.
o Collaborate with team to resolve complex or unclear situations.
EDUCATION REQUIREMENTS: Registered Nurse (Associate degree); Bachelor’s degree in a Scientific discipline, Life Sciences, Medicine, or other technical discipline.
EXPERIENCE REQUIREMENTS:
Experience of at least 5 years in the medical industry in addition to at least 2 years of Safety monitoring experience. A background in structual heart is also strongly preferred.
· Experience in conducting clinical trials.
· Clinical knowledge and understanding of medical records and medical diagnostic report review.
Job Type: Full-time
Pay: $110,000.00 - $130,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- Monday to Friday
Work Location: Remote
