Team Lead, Consent Form Development

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 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 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, 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 Summary

The Team Lead demonstrates expert understanding of the Consent Form Development (CFD) Editor role and responsibilities and provides mentorship and training to Editors. In addition, Team Lead edits informed consent forms (ICFs) to ensure that they accurately reflect the content of the research study protocol, are consistent with other study materials, and comply with applicable laws, regulations, and guidelines. Team Lead also completes projects as defined by management.

Job Duties & Responsibilities

Mentors and trains Editors:

• Reviews work for compliance with policies, Standard Operating Procedures (SOPs), and guidance documents
• Trains, supports, and evaluates Editors
• Mentors new Editors
• Serves as a contact for questions from MC and Client Services staff
• Coordinates with other team members and Managers to ensure consistency in responses

Conducts an accurate pre-review of new and revised consent forms:

• Ensures regulatory compliance with applicable FDA, HHS, Health Canada, TCPS2 regulations, ICH GCP guidance, and operational compliance with Advarra Standard Operating Procedures and Work Instructions
• Edits new and revised consent forms using the ICF and HIPAA Checklist to ensure regulatory compliance and alignment with Advarra operational standards
• Applies negotiated Sponsor and site language to consent form documents as required by client agreements and documented in mandatory language documents or MLD’s
• Collaborates with Board members and staff to include all necessary edits to the consent form from various stakeholders.
• Completes informed consent quality control check for themselves and others

Maintains and increases individual regulatory knowledge to assist with organizational compliance:

• Maintains and increases knowledge of U.S. and/or Canadian Regulations and Guidelines in the area of Human Subject Protections, drug research, device research, and cosmetic research
• Completes standard Human Subjects Research Training, such as CITI, on a repeating cycle determined by management
• Completes organizational training as required by management
• Attends one IRB meeting per month to enhance knowledge and understanding of IRB processes (two meetings per month during the initial training period)
• Offers process improvement suggestions and assists with development and implementation of these process improvements

Location

This role is open to candidates working in remotely in the United States.

Basic Qualifications

• Bachelor’s degree (preferred) or four (4) years of equivalent combination of education or experience in clinical research setting
• Certified IRB Professional (CIP) or completion of CIP within 1 year of eligibility

Preferred Qualifications

• Minimum of two years of experience in technical/medical writing and/or editing; experience writing and/or editing consent forms or other research documents
• 1-2 years of IRB experience
• 1 year of demonstrated expertise in the Advarra CFD process

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
• Focu