Director, 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 Director, Research Compliance has the responsibility, as assigned, to serve in a team leadership role, operate as a client liaison, and provide consultancy services as an individual or as part of an increasingly diverse consulting group for Advarra Consulting Client projects.   

The Director professionally applies working knowledge and regulatory expertise in clinical research, quality assurance, regulatory affairs, research administration, research compliance, research operations and other diverse areas, as assigned by the management team, to effectively manage services and project deliverables to Clients. The Director is responsible for achieving goals and objectives jointly established with Advarra Leadership. The Director represents Advarra Consulting on Business Development /Sales calls with potential clients, assists with the preparation of proposals/statement of work/scope of work, and presents at defense meetings/calls. The Director must work closely with the other Advarra Consulting Directors and Leadership, Sales/Commercial team, Marketing and Project Management to collaboratively grow the overall Advarra Consulting service line. 

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. Position must maintain a goal of a billable utilization rate of 70% to ensure bonus eligibility. 

Job Duties & Responsibilities 

• Assisting Consulting leadership in the oversight of Consulting Services provided to Clients 
• Assisting in the supervision and allocation of resources relating to Client projects 
• Providing training, oversight, and serves as a mentor to departmental staff members and independent sub-contractors 
• Establishing, cultivating, and maintaining relationships with specific clients as the primary point of contact for all service-related client communication and cross-project issues 
• Collaborates with Marketing to develop collateral for Advarra Consulting Services 
• Participates in thought leadership activities for Advarra Consulting, including but not limited to, the development of blogs, white papers, and case studies. Thought leadership also includes presenting at Advarra sponsored webinars & professional conferences 
• Attend and participate in management and infrastructure support meetings 
• Evaluate processes and gauge ongoing procedural compliance within Advarra Consulting and influence process improvement initiatives 
• Represent Advarra Consulting on Business Development /Sales calls 
• Collaborates with other business units within Advarra Consulting to identify talent and project management goals  
• Advise on the development of departmental Standard Operating Procedures, Guidelines and other tools to support Client consulting services 
• Performs other assignments as directed by the Advarra Consulting Management Team 

Position may require extensive travel, up to 50% at times. 

Location 

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

Basic Qualifications 

• Bachelor’s degree, or equivalent, from an accredited college or university required 
• Preferred: Advanced degree (e.g., Ph.D., JD, MS); Degree in Nursing, Science, or related field (or equivalent) 
• Preferred: Certifications related to ethics review, research, and/or research compliance (e.g., CIP, RAC, CHRC) 
• Minimum of eight (8) years in the life science consulting, regulatory, or legal fields 
• Three (3) + years of management experience in a related field 
• Experience with U.S. and international legal and regulatory standards and compliance 

Preferred Qualifications  

• Demonstrated working knowledge of regulatory matters related to research administration, compliance, and operations. 
• Aptitude and knowledge to provide oversight of and/or perform Regulatory support for Academic or Institutional Research, or pharmaceutical sponsors.  
• Working proficiency in Microsoft Office (Word, Excel, and Power Point). 
• Project management and team building skills. 
• Excellent organizational and time management skills. 
• Outstanding interpersonal, communication, and writing skills. 
• Ability to analyze a variety of data points to solve complex problems.  
• Ability to work independently; planning, organizing, scheduling, and completing work within deadlines. 
• Ability to manage conflicting demands and priorities through research, problem solving and critical thinking. 

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 $130,000.00 - $221,900.00. 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. 

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