Safety Specialist II

Overview

Atri Cure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use Atri Cure technologies for the treatment of Afib and reduction of Afib related complications. Atri Cure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib.

Atri Cure's Atri Clip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. Atri Cure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. Atri Cure's cryo

ICE cryo

SPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit  or follow us on Twitter @Atri Cure.

We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

The Safety Specialist II will be responsible for safety-related aspects of clinical trials conducted by the Atri Cure Clinical Affairs department. This person is responsible for coordinating and managing aspects of safety for assigned clinical trials. Responsibilities include upholding execution of safety related processes during the course of a trial as dictated by current country specific Regulations, Protocol, Safety Management Plan (SMP) as well as Standard Operating Procedures (SOP) and Work Instructions (WI).

This position may assist in planning, start-up, execution, data collection, coding, and reporting safety data for clinical studies. This role is involved in collection and processing of clinical study adverse event data, assessment of data, coding, preparation for adjudication, tracking, reporting and analysis of safety data. This position works closely with multiple departments such as Clinical Science, Complaints, Regulatory Affairs, Medical Directors, CRAs, Investigative Sites, and external vendors.

• Ensures compliance and adherence to safety aspects for assigned clinical trials including collection, processing, coding and tracking of (Serious) Adverse Events (AE/SAE) reports and adverse event documentation including safety narratives
• Coordinates and manages reconciliation of AE/SAEs, preparing cases for adjudication, writing event narratives, cleaning data, coding Medical Dictionary for Regulatory Activities (MedDRA) etc.
• Participates in the development of safety sections for documents such as clinical trial protocols, informed consents, case report forms, site selection materials, data collection and reporting instructions, investigator updates and other project-specific documents required for the conduct of assigned studies in accordance with current applicable regulations, good clinical practices (GCPs), and industry best practices pertaining to safety
• Provides input to and reviews the SMP and other materials required for conduct, and maintenance of assigned clinical studies for assigned studies in accordance with applicable regulations and best practices pertaining to safety
• Provides input toward SOP and WIs for the Clinical Affairs department
• Provides input in the review of interdisciplinary study-specific documents for consistency and compliance
• Ensures timely reporting of AEs, SAEs and UADE’s, in accordance with applicable regulations, protocols, and company procedures
• Ensures integrity and quality of safety data including reconciliation of safety data listings

• Bachelor's degree or equivalent is required
• Minimum of two years of clinical safety experience is required
• Proficient knowledge of Microsoft Office suite
• Experience with writing of safety narratives
• Working knowledge of MedDRA terminology and its application
• Familiarity with EDC systems (e.g. Clindex)
• Skilled at working effective in a collaborative team environment
• Independently motivated, detail oriented, analytical and strong problem-solving ability
• Knowledge and understanding of FDA and Global Regulations and Guidelines for the conduct of clinical trials
• Ability to exercise judgment and determine appropriate action
• Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment, and manage competing deadlines
• Exceptional verbal and written communication skills

• Previous experience in Medical Safety, Clinical Research, and/or working with a Medical Device Sponsor company or CRO
• Experience with safety monitoring in medical device industry
• Previous experience working as a safety specialist within a cardiology therapeutic area
• Demonstrated success in collaborating with and communicating effectively across…