Coordinator I, IRB Support

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
This position provides administrative IRB Support services to the Boards in the preparation and management of high-quality board meeting minutes. This position will also offer general administrative support as requested of the IRB Support Team.
Job Duties & Responsibilities

Attend IRB Meetings as assigned and draft meeting minutes:

Attend at least two IRB meeting per week, more when business needs require, and prepare draft minutes of IRB meetings using tools such as Zoom, WebEx, and SharePoint

Prepare for IRB meetings by conducting a pre-review of the assigned agenda to ensure all regulatory requirements are accurately identified for each submission by utilizing internal support documents, such as the pre-review checklist and minutes notes document

Collaborate with the Meeting Coordinator and the Board Chair prior to the IRB meeting to review assigned agenda items to identify any questions or concerns with the regulatory requirements, as needed

Record meeting minutes in a timely manner, generally sending for IRB Support QC review within 4 business days of the IRB meeting, focusing on documentation of controverted issues identified during the IRB meeting, compliance with IRB policies and procedures, standard operating procedures and Meeting Minutes template and work instructions,

Proofread and edit final IRB meeting minutes to ensure accuracy

Collaborate with the Board Chair to edit and finalize IRB meeting minutes in a timely manner

Provide IRB meeting attendance coverage for other IRB Support Coordinators as needed

Maintain meeting minutes compliance with U.S. and/or Canadian Regulations and Guidelines in the area of Human Subjects Protections

Complete standard Human Subjects Research Protections Training, such as CITI, on a repeated cycle as determined by management

Complete organizational training as determined by management

Assist in IRB Support Department and Company projects as they relate to the IRB Support Team

Offer process improvement initiatives to management, as applicable

Other duties as assigned

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

Bachelor’s Degree or Associates Degree

2+ years industry or office experience

Preferred Qualifications

1 year of IRB or Clinical Research Industry experience

Basic knowledge of Federal laws and guidelines pertaining to Human Subjects Protections Research

Must be detail-oriented and possess problem solving skills

Ability to communicate effectively in English, both verbal and in written

Effective written communication skills, including ability to summarize complex discussions

Excellent interpersonal skills to work effectively with others and provide high levels of customer service

Ability to follow instructions and work independently as required; plan, organize, schedule and complete work within deadlines

Ability to manage conflicting demands and priorities

Ability to adapt to changes in office technology, equipment, and/or processes

Demonstrated consistency and dependability in attendance, quantity and quality of work

Flexibility with changing priorities

Intermediate computer skills required, including experience with Microsoft Office products
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, 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 $50,000 - $66,974. 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.
Originally posted on Himalayas