Sr. Coordinator, Safety

Company Information

At Advarra, we are passionate about making a difference in the world of clinical research and advancing human health. With a rich history rooted in ethical review services combined with innovative technology solutions and deep industry expertise, we are at the forefront of industry change. A market leader and pioneer, Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials.

Company Culture

Our employees are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.

At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each employee is not only valued but empowered to thrive and make a meaningful impact.

Job Overview Summary

The Sr. Coordinator, Safety manages incoming safety information documentation and generates time-sensitive documents. This position requires attention to detail, a high level of accuracy, good communication skills and the ability to meet strict processing guidelines.

Job Duties & Responsibilities

• Execute processing of all Safety submissions materials in compliance with internal procedures, quality standards, timelines, and external regulations
• Analyze incoming safety submissions
• Data entry for CIRBI Product Tracker database
• Ensure complete and accurate processing and documentation of safety information for review by the Board
• Prepare and produce safety documents with accurate data entry under strict timelines
• Provide quality internal customer service
• Review and respond to internal inquiries in a timely manner
• Interface with internal departments including Client Services, IRB Services, Client Experience, Client Success, and Regulatory, to manage activities associated with Prompt Reporting Event submissions
• Provide proactive service and communication between Client Service Coordinators and other teams to ensure a high level of responsiveness and customer service
• Communicate with the Client Services and Quality Controls teams as needed to ensure all safety documents are received, processed, and distributed accurately and appropriately
• Assist with training of new hires and ongoing training with other team members (as needed)
• Manage changing priorities and workload with flexibility and adaptability while still maintaining accuracy and meeting established deadlines

Location

This role is open to candidates working remotely in the United States

Basic Qualifications

Physical and Mental Requirements

Advarra is an equal opportunity employer that is committed to diversity, equity and inclusion and providing a workplace that is free from discrimination and harassment of any kind based on race, color, religion, creed, sex (including pregnancy, childbirth, and related medical conditions, sexual orientation, and gender identity), national origin, age, disability or genetic information or any other status or characteristic protected by federal, state, or local law. Advarra provides equal employment opportunity to all individuals regardless of these protected characteristics. Further, Advarra takes affirmative action to ensure that applicants and employees are treated without regard to any of these protected characteristics in all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and separation from employment.

Pay Transparency Statement

The base salary range for this role is $​49,200 - $​83,600. Note that salary may vary based on location, skills, and experience and may vary from the amounts listed above. This position may also be eligible for a variable bonus in addition to base salary as well as health coverage, paid holidays, and other benefits.