Coordinator II, Quality Control

Advarra; Northern (KY); Hybrid; USD 54,000 - 89,000; Full time

Benefits offered by this job

Health coverage

Paid holidays

Other benefits

Job summary

Advarra is seeking a Quality Control Coordinator II to perform QC on IRB and staff documentation, ensuring accuracy against primary sources and compliance with Advarra standards and federal regulations. The role requires independent judgment, attention to detail, and collaboration with the Manager and leadership to meet organizational goals.

The ideal candidate has a Bachelor’s degree in health science or related field and at least 1 year of IRB/clinical research or quality control experience,

Qualifications

• Bachelor’s degree in health science or related field or equivalent experience.
• 1+ year IRB, clinical research, or quality control experience.
• Basic knowledge of Federal laws and guidelines pertaining to Human Subjects Research Protection.
• Proficient with MS Word and Outlook.
• Familiar with Excel, PowerPoint, Slack, Zoom, and web-based proprietary software.

Responsibilities

• Effectively performs the duties of the Quality Control Coordinator II, demonstrating strong attention to detail and sound judgment.
• Reviews and critically analyzes documents for accuracy in content for assigned submission types.
• Provides clear feedback to communicate errors to Research Services staff regarding missing and/or incomplete elements.
• Accomplishes daily workload priorities with flexibility and adaptability.
• Executes procedures in compliance with internal quality standards and external regulations.
• Support supervisor or director vision of team performance through timely processing of delegated tasks, appropriate escalation of workflow concerns, and proactive process improvement suggestions.
• Participates in team and department professional and personal development initiatives while maintaining a high level of integrity through cooperative and respectful interactions with colleagues.
• Performs quality control of recruitment, subject facing, translated and generic material submissions as well as initial site reviews and site modifications (e.g., Change of Investigator, Sub-Investigator, Location, Disclosure of Conflict of Interest, or Informed Consents, including propagated modifications; HIPAA or Consent requests). Also performs quality control on study level Protocol or Product Information modifications that do not impact Informed Consent templates.
• Performs other duties as assigned

Skills

Attention to detail

Time management

Verbal communication

Teamwork

Education

Bachelor’s degree in health science or related field

1+ year IRB/clinical research/quality control experience

Tools

MS Word

Outlook

Excel

PowerPoint

Slack

Zoom

web-based proprietary software

Job description

Remote - U.S.A
United States of America, 000000, USA

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 industryexpertise, we are at the forefront of industry change. A market leader and pioneer, Advarrabreaksthe 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, weseekto 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 roleconducts Quality Control (QC) activities on IRB and staff documentationto ensure accuracy compared to primarysources and adherence to all applicable Advarra quality control standards, federal regulations, and timelines.Requires independent judgment, attention todetailand accountability.Works with the Manager and leadership team toidentifystrategies and methods to achieve organizational goals.

JobDuties & Responsibilities

• Effectively performs the duties of a Quality Control CoordinatorII,demonstratingstrong attention to detail,andsound judgment
• Reviews and critically analyzes documents for accuracy in content for assigned submission types
• Provides clear feedback to communicateerrors to Research Services staffregardingmissing and/or incomplete elements
• Accomplishes daily workload priorities with flexibility and adaptability
• Executes procedures in compliance with internal quality standards and external regulations
• Support supervisor or director vision of team performance throughtimelyprocessing of delegated tasks,appropriate escalationof workflow concerns, and proactiveprocess improvement suggestions
• Participatesin team and department professional and personal development initiatives whilemaintaininga high levelof integrity through cooperative and respectful interactions with colleagues
• Performs quality control of recruitment, subject facing, translated and generic material submissions as well as initial site reviews and site modifications (e.g., Change of Investigator, Sub-Investigator, Location, Disclosure of Conflict of Interest, or Informed Consents [including propagated modifications]; HIPAA oreConsentrequests). Also performs quality control on study level Protocol or Product Information modifications that do notimpactInformed Consent templates.
• Performs other duties as assigned

Location

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

BasicQualifications

• Bachelor’s degree in health science or related field, or equivalent combination of education and experience
• One(1)+year(s)of IRB,clinical research, or quality controlexperience
• Basic knowledge of Federal laws and guidelinespertaining toHuman Subjects Research Protection
• Proficient with MS Word and Outlook
• Familiar with Excel, PowerPoint, direct messaging applications such as Slack, remote meeting applications such as Zoom, and web-based proprietary software

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 andcomprehendbasic 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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.