[Hiring] Editor II, Consent Form Development @Advarra

Role Description

The Editor II, 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 human subject research.

• 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.

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.

Requirements

• Some clinical research experience.
• Ability to communicate clearly and professionally 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.

Benefits

• The base salary range for this role is $54,029 - $89,148.
• This position may also be eligible for a variable bonus in addition to base salary.
• Health coverage, paid holidays, and other benefits may also be available.