Sr Consultant, Research Compliance

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 Sr. Consultant provides a broad range of independent support to Advarra Consulting clients. The role supports the mission of Advarra through flexible consulting support on various projects to improve compliance, operations and business processes for Advarra’s clients. This position reports to the Associate Director, Institutional Research Center of Excellence (IR CoE).

The Senior Consultant professionally applies working knowledge and expertise in Research Administration, Research Compliance and Research Operations. This includes, but is not limited to, Human Research Protection Programs (HRPP), research finance, clinical research operations, conflicts of interest, research misconduct, and other research roles. The IR CoE offers consulting in diverse areas as assigned by the Advarra Consulting management team to effectively provide services and project deliverables to Clients. These areas and projects may expand or change based on business needs. If assigned, the Senior Consultant may also serve in the role of Program Lead for specific Client Projects, under the supervision of a Director Level individual.

Position may require travel depending on engagement and client needs up to 50% (e.g. onsite long-term engagements at Advarra clients located across North America). Position is eligible to be home based and must be 80% billable utilization.

Job Duties & Responsibilities

• Provides a wide variety of Senior level consulting for services offered to Advarra clients
• Works individually or as part of an Advarra consulting team to meet scope of work objectives, client expectations, and deliverables
• Performs consulting assignments in the field or remotely. Typical engagements may include:
• Advise clients of the national, regional, and local regulatory and legal framework related to the review and approval of human subject’s research conducted in the United States, Canada, and other countries (EU, EEA)
• Work with clients to implement research compliance programs
• Lead development and improvement initiatives related to client’s research administration, compliance or operational programs through revision of policies, standard operating procedures, and other documents
• Lead 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
• Leads cross-departmental initiatives, projects, and requests, as assigned
• Develops and fosters client relationships to ensure new or repeat business. Seeks opportunities to expand consulting work with clients
• Actively promotes the IR CoE through thought leadership including the development of blogs, appearance in webinars, writing of white papers, etc.
• Supports the Advarra services and technology as needed
• Performs other duties as required
  
  
  

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
• Advanced Degree, a plus (JD, PhD, MPH, etc.)
• Strongly Preferred: Certifications related to ethics review, research, and/or research compliance (e.g. CIP, CHRC, RAC, CCRA, CCRP, etc.)
• 5-10 plus years of experience in Life Science, Research Administration, HRPP, or similar field
• Demonstrated working knowledge and application of OHRP, FDA, and ICH GCP regulations
• Demonstrated working knowledge of US federal regulations and guidance related to research development, conduct, oversight, accreditation, human subjects protection and research compliance. Knowledge/experience in international legal and regulatory standards and compliance a plus
  
  
  

Preferred Qualifications

• Prior experience in clinical research a plus
• Prior consulting experience a plus
• Ability to work effectively with a number of internal and external stakeholders
• Ability to work independently without a great deal of supervision
• Ability to develop and maintain systems and procedures related to project and tasks management
• 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
  
  
  

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 $86,900.00 - $146,900.00. 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.