Advarra provides integrated solutions that safeguard trial participants, empower clinical sites, ensure compliance, and optimize research performance. Connecting the clinical research ecosystem, Advarra delivers solutions through a site-centric approach that unifies and accelerates the drug development lifecycle, making clinical trials safer, smarter, and faster.

General Summary
The Client Services Manager is responsible for providing 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 client assistance and advisement to facilitate IRB review, and translates IRB decisions and processes to clients to maintain continuity and timely communications.

Principal Duties & Responsibilities

• Assist Client Services Coordinators with routine day-to-day questions and activities
• Track team metrics to ensure timelines are being met
• Manage re-allocation of work during Client Services Coordinator absences
• Prepare updates of Division Work Instructions and SOP's as needed
• Serve as a back up to Quality Control activities
• Serve as Coordinator for high-profile clients as needed
• Assist with client start-up activities, as requested
• Coordinate and lead Division-specific projects
• Provide "on-the-job" training for new coordinators
• Assign clients/protocols to an appropriate Client Services Coordinator
• Hold Client Services meetings on a routine basis
• Conduct process improvement initiatives
• Attend IRB meetings as needed
• Research and assist on regulatory questions
• Immediately report client-related, timeline, and/or quality issues to Director
• Assist team by taking escalated calls
• Attend conferences and workshops to stay abreast with changes in the industry
• Assist with the management of third-party vendor relations for translation services
• Other duties as assigned

Job Requirement

Education

• Bachelor's degree or four (4) years of equivalent experience
• Certified IRB Professional (CIP) or attainment of CIP within one (1) years of eligibility (preferred)

Experience

• Minimum of 4 years' experience in IRB or clinical research setting that includes applying regulations to the protection of human subjects
• Intermediate computer skills, including proficiency with MS Office Suite with an emphasis on Word and Outlook
• Ability to effectively use proprietary system

Knowledge, Skills, Abilities

• Knowledge of Federal laws and guidelines pertaining to Research and the Use of Human Subjects including the FDA and DHHS
• Employee supervision and development including motivation, leadership, performance appraisal, training, and career development
• Write and speak in English to compose business text such as letters, memos, e-mails and reports; copy or transcribe information; summarize or condense information; edit, revise, correct, proofread
• Listen, understand, and interpret scientific and medical dialogue to be able to quickly and accurately process IRB meeting minutes
• Read and understand research texts such as medical protocols and Informed Consent Forms
• Must have high level of attention to detail, accuracy and thoroughness; Problem solving skills
• Highly organized and efficient; Process and procedure oriented
• Excellent interpersonal skills to work professionally and effectively with others and provide high levels of customer service
• Ability to follow written and verbal instructions and work independently as required - plan, organize, schedule and complete work within deadlines
• Ability to manage conflicting demands and priorities
• Ability to adapt to changes in office technology, equipment and/or processes
• Demonstrated consistency and dependability in attendance, quantity and quality of work
• Travel as needed for training and development of staff

• Demonstrates an in-depth, regulations-based understanding of research protocols
• Display a clear attitude of customer service, verbally, visually and in writing
• Display knowledge of the functionality of CIRBI

Physical and Mental Requirements

• Sit or stand for extended periods of time at stationary work station
• 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

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EEO Statement
Advarra provides equal employment opportunity to all individuals regardless of their race, color, religion, creed, sex, sexual orientation, gender identity, national origin, age, disability, veteran, marital, or domestic partner status, citizenship, genetic information or any other status or characteristic covered by federal, state or local law. Further, the company takes affirmative action to ensure that applicants are employed, and employees are treated during employment without regard to any of these characteristics. Discrimination of any type will not be tolerated. EEO/M/F/Disabled/Vets

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Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)