Sr. Coordinator, Client Services

Advarra; Northern (KY); Hybrid; USD 67,000 - 119,000; Full time

Benefits offered by this job

Health coverage

Paid holidays

Other benefits

Job summary

Advarra is seeking a Sr Coordinator to provide exemplary client service and act as the primary contact for pharmaceutical companies, CROs, and academic medical centers to facilitate IRB review and translate decisions to clients. This remote US role emphasizes timely communication and coordination of complex submissions.

The position requires a bachelor’s degree or equivalent experience with 4+ years in IRB/clinical research, CIP preferred, and strong MS Office skills.

Qualifications

• Bachelor’s degree or four years of equivalent experience.
• Four (4) years’ experience in IRB or clinical research setting that includes applying regulations to the protection of human subjects.
• Certified IRB Professional (CIP) or attainment of CIP within one year of eligibility
• Intermediate computer skills including proficiency with MS Office Suite (Word/Outlook) and ability to use a proprietary system

Responsibilities

• Serves as the main Sponsor/CRO and PI/site contact on assigned studies
• Manages the day-to-day relationship for assigned top-tier accounts
• Reviews Protocol/site submissions and supporting documentation
• Demonstrates an advanced understanding of multiple types of Protocol and Site Submissions
• Documents and executes client customizations; processes change requests
• Manages vendor relations and documentation for foreign language translations
• Maintains high level of accuracy and timely communication with customers (within 24 hours)

Skills

IRB experience

CIP certification

MS Office

FDA/DHHS knowledge

English writing

Attention to detail

Education

Bachelor's degree or 4 years equivalent experience

Tools

MS Office Suite

Proprietary system

Job description

Remote - U.S.A
United States of America, 000000, USA

Description

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 industryexpertise, we are at the forefront of industry change. A market leader and pioneer, Advarrabreaksthe 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, weseekto 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 Coordinatoris responsible forproviding exemplary client service and serves as the main point of client contact for designated pharmaceutical companies, contract research organizations, and academic medical centers. This position will provide direct clientassistanceand advisement tofacilitateIRB review andtranslatesIRB decisions and processes to clients tomaintaincontinuity andtimelycommunications.

JobDuties & Responsibilities

• Serves as the main Sponsor/CRO and PI/site contact on assigned studies
• Manages the day-to-dayrelationship forassigned top tier accounts
• Manages review of Protocol/site submissions by reading, reviewing, and understanding protocol and all supporting documentation
• Demonstrates an advanced understanding of multiple types of Protocol and Site Submissions
• Documents and executes client customizations; processes change requests
• Manages vendor relations and documentation for foreign language translations
• Maintainsa high levelof accuracy and attention to detail and collaborates with the quality assurance team to ensure a minimal rate of error. Completes workin a timely manner, responding to customers within 24 hours of email/voicemail receipt
• Escalates any customer or timeline issues to management
• Assistswith process improvement initiatives
• Attends conferences and workshops
• Other duties as assigned

Location

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

BasicQualifications

• Bachelor’s degreeorfour yearsof equivalentexperience
• Four (4) years’ experience in IRB or clinical research setting that includes applying regulations to the protection of human subjects

Preferred Qualifications

• Certified IRB Professional (CIP) or attainment of CIP within one (1)yearsof eligibility
• Intermediate computer skills, includingproficiencywith MS Office Suite with an emphasis on Word and Outlook
• Ability to effectively use proprietary system
• Knowledge of Federal laws and guidelinespertaining toResearch and the Use of Human Subjects including the FDA and DHHS
• Write and speak in English to compose business text such as letters, memos,e-mailsand reports; copy or transcribe information; summarize or condense information; edit, revise, correct, proofread
• Listen,understandand interpret scientific and medical dialogue to be able toquickly and accurately communicate IRB determinationsto clients.
• Read and understand research texts such as medical protocols and Informed Consent Forms
• Must havehigh levelof attention to detail,accuracyand thoroughness; Problem solving skills
• Highly organized and efficient; Process and procedure oriented
• Excellent interpersonal skills to work professionally and effectively with others and providehigh levelsof customer service
• Communicate clearly and professionally, both verbally and inwriting;public speaking
• High levelof professionalism and discretion with all communication with clients
• Ability to follow written and verbal instructions and work independently asrequiredto plan, organize, schedule and complete work within deadlines
• Ability to manage conflicting demands and priorities
• Ability to adapt to changes in office technology,equipmentand/or processes
• Demonstrated consistency and dependability in attendance,quantityand quality of work

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 andcomprehendbasic 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. Advarraprovidesequal employmentopportunityto 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 $66,767- $119,089. 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

This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.