Consultant, Research Compliance

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 Consultant provides a broad range of support to Advarra Consulting clients, both within the Regulatory Consulting Practice area, as well as within other service line areas as needed. The role supports the mission of Advarra by providing flexible consulting support to Advarra Clients with the goal of improving research compliance, operations and business processes for our clients. This position reports to the Managing Director, Research Compliance and Site Operations.

The Consultant applies working knowledge and expertise in the area of Research Administration & Research Compliance which includes Human Research Protection Programs (HRPP)/Institutional Review Board (IRB) operations, research finance, clinical operations, AAHRPP accreditation services, and other diverse areas as assigned by the Advarra Consulting Management Team.

Position is eligible to be home based which requires a self-provided designated workspace that is free from distractions and interruptions, as well as maintains a high-speed internet connection. This position must achieve 85% billable utilization. Position may require travel depending on engagement and client needs .

Job Duties & Responsibilities

• Provide a wide variety of Research Administration and Research Compliance related consulting support to Advarra clients
• Work as part of an Advarra consulting team to meet scope of work objectives, client expectations, and deliverables
• Perform consulting assignments either on-site or remotely. Typical engagements may include:
• Advise clients on national, regional, and local regulatory and legal requirements related to the review and approval of human subjects research conducted in the United States
• Work with Clients to implement regulatory compliance
• Assist with development and improvement initiatives related to Client’s Research Administration and Compliance Programs through revision of policies, standard operating procedures, work instruction and other documents/tools
• Assist with protocol and associated document development projects
• Provide regulatory support to all areas of Advarra as needed depending on the engagement.
• Develop and deliver training, webinars, and live presentations for Clients
• Assist with cross-departmental initiatives, projects, and requests, as assigned
• Promote the Consulting Practice through thought leadership, if requested
• Perform other duties as needed

Location

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

Basic Qualifications

• Bachelor’s Degree, or equivalent combination of education and related work experience
• Strongly Preferred: Certifications related to ethics review, research, and/or research compliance (e.g. CIP, CHRC, etc.)
• 3-7 years of experience in Life Science, Research Administration, HRPP/IRB, or similar field
• Demonstrated working knowledge and application of Office for Human Research Protections (OHRP), Food and Drug Administration (FDA), and ICH GCP regulations. Demonstrated knowledge of research development, conduct, oversight, accreditation, human subjects protection and research compliance. Knowledge/experience in international legal and regulatory standards and compliance a plus
• Prior experience in clinical research or human subjects research arena a plus
• Prior consulting experience a plus

Preferred Qualifications

• Strong written and verbal communication skills
• Strong interpersonal skills
• Skill in the use of computers and software programs, preferably in a PC, Windows-based operating environment
• Skill in organizing projects, tasks, and establishing priorities
• Skill in examining, developing, and editing procedures
• Knowledge of project management principles and practices
• Knowledge of technological tools (eTMF, CTMS, etc.) to complete assigned work
• Ability to work effectively with a number of internal and external stakeholders
• Ability to work independently without a great deal of supervision
• Ability to complete a high volume of routine tasks and long-term projects
• Ability to gather data, to compile information, and prepare reports
• Ability to develop, plan, and implement short- and long-range goals
• Ability to communicate effectively, both orally and in writing
• Ability to analyze and solve problems
• Ability to write and edit written materials
• Ability to apply knowledge to unique matters in order to resolve problems
• Ability to explain complex information clearly and concisely
• Ability to travel up to 50%

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

US Equal Employer Opportunity (EEO) Statement

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

The base salary range for this role is $58,300.00 - $99,200.00. 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.