Sr. Specialist, SME, Client Services

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 Senior Specialist (SME), Client Services, demonstrates expert understanding of the Client Services Coordinator (CSC) role and responsibilities and functions as a departmental source for operational issues, identifies and implements opportunities for process improvement, participates in development/revision of work instructions designed to improve CSC role efficiency. In addition, the Senior Specialist (SME), Client Services completes projects as defined by management. The Senior Specialist (SME) processes daily work for a large portfolio of assigned clients/studies and coordinates with Client Services Managers on the daily workload reassignments as needed.

Job Duties & Responsibilities

• Fulfills all duties and responsibilities of the Sr. CSC role
• Works with the Director/Sr. Director, Client Services to identify strategies and methods to achieve organizational goals
• Serves as contact for Client Services teams for operational issues
• Develops and updates Client Services work instructions when required
• Assists with training of new CSC employees
• Mentor’s new hires once the basic training processes are completed
• SME for staff to provide guidance on operations processes
• Available as SME for questions from Regulatory, UBM’s, ABM’s, IRB Services & Client Services staff
• Coordinates with other SMEs and Managers to ensure consistency in responses
• Assists Client Experience, Client Success and QA with all client questions related to Client Services processes
• Communicate with Senior Management to identify and implement strategies to improve quality, efficiency, and service standards and/or operational procedures
• Conducts an administrative review of submissions and interacts with study and site personnel to obtain missing information, resolve issues and meet timelines
• Demonstrates an advanced understanding of multiple types of protocol and site submissions
• Documents and adheres to client requirements (org/protocol notes)
• Proactively provides support to the team by assisting with reassignments
• Processes foreign language translation requests
• Maintains a high level of accuracy and attention to detail; collaborates with the quality control team to ensure a minimal rate of error
• Completes work within the expected turnaround times
• Responds to customers within 24 hours of email/voicemail receipt
• Escalates any customer or timeline issues to their direct report
• Assists with process improvement initiatives
• Assists with mentoring of junior staff
• Attends conferences and workshops
• Completes assigned training in a timely manner

Location

• This role is open to candidates working in one of the following locations: United States

Basic Qualifications

• Bachelor’s degree or five (5) years of equivalent experience in clinical research or healthcare setting preferred
• Certified IRB Professional (CIP) or attainment of CIP within one (1) year of eligibility
• Five (5) years of demonstrated proficiency in the Sr. CSC and/or Team Lead role.
• Experience fulfilling responsibilities with team-wide visibility and impact, such as routinely providing training and guidance to the Client Services team or other groups
• Demonstrated ability to perform as an expert in operational