Job description

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

Supports the IRB Services department in the review of incoming submissions and preparation of informed consent forms (ICFs) used in the conduct of human subject research.

Job Duties & Responsibilities

• Conduct accurate pre-reviews of new and revised consent forms to ensure regulatory compliance with FDA, HHS, Health Canada, TCPS2 regulations, ICH GCP guidance, and Advarra Standard Operating Procedures and Work Instructions
• Edit new and revised consent forms to align with regulatory standards and Advarra document requirements
• Incorporate negotiated Sponsor language into consent form documents as outlined in client agreements
• Collaborate with Board members and staff to incorporate necessary edits from various stakeholders into consent forms
• Maintain and enhance knowledge of U.S. and/or Canadian Regulations and Guidelines related to Human Subject Protections, drug research, device research, and cosmetic research
• Complete standard Human Subjects Research Training, such as CITI, on a recurring cycle determined by management
• Fulfill organizational training requirements as directed by management
• Attend at least one IRB meeting per month to enhance understanding of IRB processes (two meetings per month during initial training period)
• Offer suggestions for process improvements to management as appropriate

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

Basic Qualifications

• Minimum of one year of experience in technical/medical writing and/or editing in addition to a Bachelor’s degree
• Experience writing and/or editing consent forms or other research documents
• Proficiency in Word processing and editing (including use of Tracked Changes and Compare Merge functions)
• Familiar with Excel, PowerPoint, direct messaging applications such as Slack, remote meeting applications such as Zoom or RingCentral, and web-based proprietary software

Preferred Qualifications

• Some clinical research experience
• Experience writing and/or editing consent forms or other research documents
Physical and Mental Requirements
• Sit or stand for extended periods of time at stationary workstation
• Regularly carry, raise, and lower objects of up to 10 Lbs.
• Learn and comprehend basic instructions
• Focus and attention to tasks and responsibilities
• Verbal communication; listening and understanding, responding, and speaking

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 $36,200 - $61,500. 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.

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