Sr. Editor, Consent Form Development

Company InformationAt 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 CultureOur 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 SummarySupports the IRB Services department in the review of incoming submissions and preparation of informed consent forms (ICFs) used in the conduct of human subjects research. In addition, the Senior Editor may mentor new editors and complete projects as defined by management.Job Duties & ResponsibilitiesConduct an accurate pre-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 InstructionsEdit new and revised consent forms to ensure regulatory compliance and alignment with Advarra operational standardsApply negotiated Sponsor and site language to consent form documents as required by client agreements documented in mandatory language documents or MLD'sCollaborate with Board members and staff to include all necessary edits to the consent form from the various stakeholdersComplete informed consent quality control check for yourself and othersMentor new team members, as requestedMaintain and increase individual regulatory knowledge to assist with organizational compliance:Maintain and increase knowledge of U.S. and/or Canadian Regulations and Guidelines in the area of Human Subject Protections, drug research, device research, and cosmetic researchComplete standard Human Subjects Research Training, such as CITI, on a repeating cycle determined by managementComplete organizational training as required by managementAttend one IRB meeting per month to enhance knowledge and understanding of IRB processes (two meetings per month during the initial training period)Offer process improvement suggestions to management, as applicableOther duties as assignedLocationThis role is open to candidates working remotely in the United States.Basic QualificationsMinimum of 2 years of experience in technical/medical writing and/or editing in addition to a Bachelor's degreeExperience writing and/or editing consent forms or other research documentsProficiency 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 softwarePreferred Qualifications1 year of IRB experienceExperience writing and/or editing consent forms or other research documentsCertified IRB Professional (CIP) or completion of CIP within two (2) years of eligibilityAbility to communicate clearly and professional in English, both verbal and written skillsExcellent interpersonal skills to work professionally and effectively with others and provide high levels of customer serviceIn-depth knowledge of matters regarding human subjects research and informed consentFamiliar with scientific/medical terminology and able to convert scientific/medical information to lay termsAbility to edit technical and/or medical documentsAbility to read and comprehend advanced technical/medical documents such as medical protocols and informed consent formsAbility to manage various editing projects under conflicting demands and prioritiesDependably produces high quality workMust have high level of attention to detail, accuracy and thoroughness; problem solving skillsAbility to follow written and verbal instructions and work independently as requiredPhysical and Mental RequirementsSit or stand for extended periods of time at stationary workstationRegularly carry, raise, and lower objects of up to 10 Lbs.Learn and comprehend basic instructionsFocus and attention to tasks and responsibilitiesVerbal communication; listening and understanding, responding, and speakingAdvarra 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 StatementThe 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. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) Apply tot his job Apply To this Job