Editor II (Informed Consent)

Posted Jan 26

Job Details

Description

General Summary

The Editor II 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.

Principal Duties & Responsibilities

  1. Conduct 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 Instructions
  2. Edit new and revised consent forms to ensure regulatory compliance and alignment with Advarra document standards
  3. Apply negotiated Sponsor language to consent form documents as required by client agreements documented in mandatory language documents or MLD’s.
  4. Collaborate with Board members and staff to include all necessary edits to the consent form from the various stakeholders
  5. Maintain and increase individual regulatory knowledge to assist with organizational compliance by:
  6. 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 research
  7. Complete standard Human Subjects Research Training, such as CITI, on a repeating cycle determined by management
  8. Complete organizational training as required by management
  9. Attend one IRB meeting per month to enhance knowledge and understanding of IRB processes (two meetings per month during the initial training period)
  10. Offer process improvement suggestions to management, as applicable
  11. Other duties as assigned

Education

  • Bachelor’s degree (preferred)

Experience

  • Minimum of one year 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 preferred
  • Some clinical research experience preferred
  • 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

Knowledge, Skills, and Abilities

  • Communicate clearly and professionally in English, both verbal and written skills
  • Excellent interpersonal skills to work professionally and effectively with others and provide high levels of customer service
  • Willingness to gain basic, working 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
  • Able to edit technical and/or medical documents
  • Able to read and comprehend advanced technical/medical documents such as medical protocols and informed consent forms
  • Able to manage various editing projects under conflicting demands and priorities
  • Able to work remotely and/or work with remote workers using the latest technologies
  • Dependably produces high quality work
  • Must have high level of attention to detail, accuracy and thoroughness; problem solving skills
  • Able 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

EEO Statement

Advarra provides equal employment opportunity to all individuals regardless of their race, color, religion, creed, sex, sexual orientation, gender identity, national origin, age, disability, veteran, marital, or domestic partner status, citizenship, genetic information or any other status or characteristic covered by federal, state or local law. Further, the company takes affirmative action to ensure that applicants are employed, and employees are treated during employment without regard to any of these characteristics. Discrimination of any type will not be tolerated.  

EEO/M/F/Disabled/Vets

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)