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 role conducts Quality Control (QC) activities on IRB and staff documentation to ensure accuracy compared to primary sources and adherence to all applicable Advarra quality control standards, federal regulations, and timelines. Requires independent judgment, attention to detail and accountability. Works with the Manager and leadership team to identify strategies and methods to achieve organizational goals.
Job Duties & Responsibilities
- Effectively perform the duties of a Quality Coordinator:
- Reviews and critically analyzes documents for accuracy in content for assigned submission types
- Communicates 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
- Offering process improvement suggestions to management, as applicable
- 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 site modifications (e.g., Change of Investigator, Sub-Investigator, Location, Disclosure of Conflict of Interest, or Informed Consents [including propagated modifications]; HIPAA or eConsent requests). Also performs quality control on study level Protocol or Product Information modifications that do not impact Informed Consent templates.
Location: US Remote
Basic Qualifications
- Minimum of one (1) year of IRB or clinical research experience
- Basic knowledge of Federal laws and guidelines pertaining to Human 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
- Preferred Qualifications
- Bachelor’s degree (preferred) or equivalent combination of education and experience
- 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 diversity, equity and inclusion and 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 or genetic information or any other status or characteristic protected by federal, state, or local law. Advarra provides equal employment opportunity to all individuals regardless of these protected characteristics. Further, Advarra takes affirmative action to ensure that applicants and employees are treated without regard to any of these protected characteristics in all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and separation from employment.
Pay Transparency Statement (Disclosed on all US reqs and removed for other countries, HR completes)
The base salary range for this role is $36,200 - $61,500. 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
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)