Description

The Clinical Safety Specialist will be responsible for conducting accurate, timely and consistent safety assessments of adverse events in Inari sponsored clinical studies/registries. This position will ensure adherence to global safety reporting vigilance throughout the clinical study process. This position will work collaboratively with the other members of the Safety Team, Clinical Program Managers, Data Managers, Biostats, Scientific Communications, Complaint Handling, external Contract Research Organizations, study team members, customers, and other internal partners to enable patient access to advanced care for the treatment of their disease.

Responsibilities

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  Interact with the clinical sites and field monitors to obtain additional source data needed for adjudication.
• Write narratives as required per the Safety Management Plan and/or as requested.
• Collaborate with other members of the safety team and cross-functional teams to ensure timely reporting of AEs/SAEs/UADEs/MAEs.
• Collaborate with Inari Safety Leadership and members of the study teams to develop clinical safety plans for assigned protocols.
• Reviews adverse events (AE’s) and serious adverse events (SAE’s) and events meeting endpoint definitions across the portfolio of clinical studies.
• Collaborate with the Medical Monitor or CEC or DSMB to ensure adjudication is conducted in accordance with the clinical protocol and safety management plan.
• Collaborate with other members of the safety team to ensure consistency in the assessment, recording and coding of clinical safety events.
• MedDRA coding of adverse events.
• Provide support in the Safety Review meetings.
• Maintain compliance to all SOP, GCP, and regulatory processes.
• Ensure that safety data collection is of high quality to support scientific communications, clinical research, and statistical evidence dissemination strategies.
• Understand specific study, therapy, and disease state needs and identify opportunities to provide additional value.
• Communicate clearly and effectively with sites, adjudicators, and members of the study team to ensure a high level of safety data.
• Proactively identify and address potential issues to minimize negative impact on the data.
• Strong technical knowledge of Inari products and procedures.
• Strong clinical process acumen and ability to drive clinical functional excellence.

• 4+ years of experience in clinical research.
• Bachelor’s degree in life sciences.
• Proficient with electronic databases used for clinical trials.
• Experience with Good Clinical Practices (GCP).
• Healthy disdain for the status quo.
• A strong attention to detail to be able to accurately review CRFs and source documents and deliver high quality output consistently and on time.
• Able to work independently.
• Demonstrated success working in a fast-moving remote work environment.
• Medical device trials experience preferred.
• Ability to thrive in times of change while adhering to cultural focus on People, Patients, and no small plans.
• Analytical and critical thinking, be able to analyze safety data entries and critically evaluate the data.
• Strong collaborative mindset and ability to work effectively with others to achieve common goals.
• Ability to function at a high level in a virtual workspace.
• A strong medical background or knowledge can be beneficial in this role

For United States Applicants Only:
Inari Medical E-Verify Poster (English and Spanish)
Inari Medical Right to Work Poster (English)
Inari Medical Right to Work Poster (Spanish)