Coordinator Ii, Client Services

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.
The Client Services Coordinator II 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.
This position is available remotely.
Principal Duties & Responsibilities

• Escalates any customer or timeline issues to management
• Documents and executes client customizations as requested; processes change requests for approved Protocols
• Completes work in a timely manner, responding to customers within 24 hours of email/voicemail receipt
• Serve as the main Sponsor/CRO and PI site/contact on assigned studies.
• Assist with other studies as needed and serve as a primary Sponsor/CRO and PI/site contact on submissions that are assigned to you
• Maintains a high level of accuracy and attention to detail and collaborates with the quality assurance team to ensure a minimal rate of error
• Conducts an administrative review of Protocol/site submissions by reading, reviewing, and understanding protocol requirements and all supporting documentation
• Other duties as assigned
• Attends conferences and workshops
• Demonstrates an advanced understanding of multiple types of Protocol and Site Submissions
• Assists with process improvement initiatives
• Manages vendor relations and documentation for foreign language translations

Job Requirement
Education

• Certified IRB Professional (CIP) or attainment of CIP within one (1) years of eligibility (preferred)
• High School Diploma is required

Experience

• Intermediate computer skills, including proficiency with MS Office Suite with an emphasis on Word and Outlook
• Ability to effectively use proprietary system
• Two (2) years’ experience in IRB or clinical research setting that includes applying regulations to the protection of human subjects.

Knowledge, Skills, Abilities

• Highly organized and efficient; Process and procedure oriented
• High level of professionalism
• Word process and type
• Excellent interpersonal skills to work professionally and effectively with others and provide high levels of customer service
• 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
• 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
• Federal laws and guidelines pertaining to Research and the Use of Human Subjects including the FDA and DHHS
• Communicate clearly and professionally, both verbally and in writing; public speaking
• Must have high level of attention to detail, accuracy and thoroughness; Problem solving skills
• Listen, understand and interpret scientific and medical dialogue to be able to quickly and accurately communicate IRB determinations to clients.
• Read and understand research texts such as medical protocols and Informed Consent Forms.

Physical and Mental Requirements:

• Verbal communication; listening and understanding, responding and speaking
• Regularly carry, raise, and lower objects of up to 10 Lbs.
• Focus and attention to tasks and responsibilities
• Sit or stand for extended periods of time at stationary work station
• Learn and comprehend basic instructions

#mogul
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