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Editor II, Consent Form Development
Advarra
Remote, USA
Full-time
Entry · 1+ years experience
Remote
USD 54029-89148 yearly / year
Discovered 1 months ago
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Key Skills for This Role
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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 Other duties as assigned
- Location This role is open to candidates working remotely in the United States.
Basic Qualifications
- 1+ years 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
- Ability to communicate clearly and professional in English, both verbal and written skills
- Strong interpersonal skills to work professionally and effectively with others and provide high levels of customer service
- Knowledge of matters regarding human subjects research 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 and comprehend advanced technical/medical documents such as medical protocols and informed consent forms
- Ability to manage various editing projects under conflicting demands and priorities
- Dependably produces high quality work
- Must have high level of attention to detail, accuracy and thoroughness; problem solving skills
- Ability to follow written and verbal instructions and work independently as required
- 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 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 $54,029 - $89,148. 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.
About Advarra
Scientific Research & Development1869 employeesFounded 1983
Clinical research services and technology company helping sponsors, CROs, sites, and investigators run safer, compliant trials.
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