Sr Editor, Consent Form Development

Remote - U.S.A
United States of America, 000000, USA

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 industryexpertise, we are at the forefront of industry change. A market leader and pioneer, Advarrabreaksthe 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, weseekto 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
Sr Editor, Consent Form Development supports the IRB Services department in the review of incoming submissions and preparation of informed consent forms (ICFs) used in the conduct of humansubjectsresearch. In addition, the Senior Editor may mentor new editors and complete projects as defined by management.

JobDuties & Responsibilities

Conductan accuratepre-review of new and revised consent forms in regulatory compliance with applicable FDA, HHS, Health Canada, TCPS2 regulations, ICH GCP guidance, and operational compliance with Advarra Standard Operating Procedures and Work Instructions

Edit new and revised consent forms to ensure regulatory compliance and alignment with Advarra operational standards

Apply negotiated Sponsor and site language to consent form documents as required by client agreements documented in mandatory language documents or MLD’s

Collaborate with Board members and staff to include all necessary edits to the consent form from the various stakeholders

Complete informed consent quality control check for yourself and others

Mentor new team members, as requested

Maintain and increase individual regulatory knowledge toassistwith organizational compliance:

Maintain and increase knowledge of U.S. and/or Canadian Regulations and Guidelinesin the area ofHuman Subject Protections, drug research, device research, and cosmetic research

Complete standard Human Subjects Research Training, such as CITI, on a repeating cycledeterminedby management

Complete organizational training as required by management

Attend one IRB meeting per month to enhance knowledge and understanding of IRB processes (two meetings per month during theinitialtraining period)

Offer process improvement suggestions to management, as applicable

Other duties as assigned

Location
This role is open to candidatesworkingremotely inthe United States.

BasicQualifications

2+years of experience in technical/medical writing and/or editing in addition to aBachelor’sdegree

Experience writing and/or editing consent forms or other research documents

Proficiencyin 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

1+yearsof IRB experience

Experience writing and/or editing consent forms or other research documents

Certified IRB Professional (CIP) or completion of CIP within two (2) years of eligibility

Ability to communicate clearly and professional in English, both verbal and written skills

Excellent interpersonal skills to work professionally and effectively with others and providehigh levelsof customer service

In-depth knowledge of mattersregardinghumansubjectsresearch and informed consent

Familiar with scientific/medical terminology and able to convert scientific/medical information to lay terms

Ability to edit technical and/or medical documents

Ability to read andcomprehendadvanced technical/medical documents such as medical protocols and informed consent forms

Ability to manage various editing projects under conflicting demands and priorities

Dependably produceshigh qualitywork

Must havehigh levelof attention to detail,accuracyand thoroughness; problem solving skills

Ability to follow written and verbal instructions and work independently asrequired

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 andcomprehendbasic 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 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.

Pay Transparency Statement
The base salary range for this role is $66,767 - $116,089. 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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.

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