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 independent preparation and management of high-quality board meeting minutes This position will also offer general administrative support to the IRB Support Team. This position will also independently author reporting letters to government oversight agencies (FDA, OHRP) following IRB policies and procedures and standard operating procedures.
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
Assist Compliance Team with audit requests for meeting minutes.
Identify, communicate, and implement strategies for continuous improvement in IRB Support operational procedures
Assist in IRB Support Department and Company projects as they relate to the IRB Support Team
Provide administrative support within the team and other teams as needed
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
3+ years industry or office experience
Preferred Qualifications
Achieved recognition from an accredited organization preferred (e.g., PRIM&R’s Certified IRB Professional (CIP) credentials or similar organization)
2+ years of IRB or Clinical Research Industry experience
Must be detail-oriented and possess problem solving skills
Ability to communicate effectively in English, both verbal and 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 $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.