Sr Editor, Consent Form Development

Advarra; Northern (KY); Hybrid; USD 67,000 - 116,000; Full time

Job summary

Advarra is seeking a Sr Editor, Consent Form Development to support the IRB Services department in reviewing submissions and preparing informed consent forms used in human subjects research. The Senior Editor may mentor new editors and complete projects as defined by management.

Role requires staying current with FDA/ICH guidelines, applying sponsor language, and ensuring high-quality documents. Remote US-based work is available, with periodic IRB meeting attendance and ongoing training.

Qualifications

• 2+ years of experience in technical/medical writing and/or editing
• Experience writing and/or editing consent forms or other research documents
• Proficiency in Word processing and editing (Tracked Changes and Compare Merge)

Responsibilities

• Conduct accurate pre-review of new and revised consent forms for regulatory compliance
• Edit consent forms to ensure regulatory compliance and alignment with Advarra standards
• Apply sponsor/site language to consent forms as required by client agreements
• Collaborate with Board members and staff to include necessary edits from stakeholders
• Complete informed consent quality control checks for self and others
• Mentor new team members as requested
• Maintain and increase knowledge of US/Canada regulations governing human subjects protections
• Complete standard Human Subjects Research Training such as CITI on a rotating basis
• Attend IRB meetings (1 per month, 2 during initial training)
• Offer process improvement suggestions to management
• Perform other duties as assigned

Skills

Technical writing

Editing

Education

Bachelor's degree

Tools

Microsoft Word

Excel

PowerPoint

Slack

Zoom

Job description

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.