Coordinator I, Ongoing Review

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 Ongoing Review Coordinator I is responsible for providing exemplary client service and serves as the client contact for designated continuing reviews or terminations. This position will provide outreach and direct client assistance to facilitate IRB continuing review. This position is also responsible for terminations, expirations and reinstatement of studies and sites. The Ongoing Review Coordinator communicates IRB decisions and processes timely communication.

This role is available remotely.

Principal Duties & Responsibilities

• Serves as Sponsor/CRO and PI/site contact for the submission and processing of continuing reviews or terminations of a study or site:
• Conducts an administrative review of Protocol/site review and termination submissions by reading, reviewing, and understanding requirements and all supporting documentation
• Maintains a high level of accuracy and attention to detail and collaborates with the quality assurance team to ensure a minimal rate of error
• Completes work in a timely manner, utilizing the CIRBI dashboard to successfully manage, process and complete all continuing review submissions prior to the expiration timeline, and all termination submissions within appropriate team established turnaround times.
• Responds to customers within 24 hours of email/voicemail receipt
• Escalates any customer or timeline issues to management
• Assists with process improvement initiatives
• Attends conferences and workshops
• Provides support and prompt attention and response to all Ongoing Review team Outlook emails.
• Other duties as assigned

Job Requirement

Education

• High School Diploma is required
• Associates Degree or equivalent combination of education and/or experience

Experience

• Two (2) years of experience in an office environment (preferably in a regulated industry)

Knowledge, Skills, Abilities

• Federal laws and guidelines pertaining to Research 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-mails and reports; copy or transcribe information; summarize or condense information; edit, revise, correct, proofread
• Word process and type
• 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.
• 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
• Communicate clearly and professionally, both verbally and in writing; public speaking
• High level of professionalism
• 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

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

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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)