Coordinator I, IRB Support

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

Advarra has as its core function the institutional review board review (IRB) review of any and all research from survey research to first-in-human research sponsored by pharmaceutical companies, biotech companies, institutions, hospitals as well as clinics and private physician offices. The regulatory group is responsible for the expedited review of research, the full board review of research and the drafting and writing of the meeting meetings. The regulatory group also collaborates with other parts of the organization on thought leadership, client guidance and operational efficiencies.

This position provides administrative regulatory support to the Boards in the preparation of high-quality board meeting documentation and management of finalized board meeting minutes. This position will also offer general administrative support to the Regulatory Support Team.

This role is available remotely.

Principal Duties & Responsibilities

• Attend IRB Meetings as assigned and draft meeting minutes:
• Attend at least two IRB meetings per week and prepare draft Minutes of IRB Meetings using tools such as Zoom, WebEx, and SharePoint
• Prepare for IRB meetings by conducting a pre-review of the assigned agenda to ensure all regulatory requirements are accurately identified for each submission by utilizing internal support documents, such as the pre-review checklist and minutes notes document
• Collaborate with the Meeting Coordinator and the Board Chair prior to the IRB meeting to review assigned agenda items to identify any questions or concerns with the regulatory requirements, as needed
• Record draft meeting minutes in a timely manner, ensuring components as required by the appropriate regulatory body, IRB policies and procedures and standard operating procedures are accurately identified and documented
• Proofread and edit final minutes to ensure accuracy
• Collaborate with the Board Chair to edit and finalize meeting minutes in a timely manner
• Provide IRB meeting attendance coverage for other Regulatory Support Coordinators as needed
• Maintain and increase U.S. and/or Canadian Regulations and Guidelines in the area of Human Subjects Protections
• Complete standard Human Subjects Research Protections Training, such as CITI, on a repeated cycle as determined by management
• Complete organizational training as determined by management
• Assist in Department and Company projects as they relate to the Regulatory Support
• Offer process improvement initiatives to management, as applicable
• Other duties as assigned

Job Requirements

Education

• Bachelor's Degree or Associates Degree with 2+ years industry or office experience

Experience

• 1 year of IRB or Clinical Research Industry experience preferred

Knowledge, Skills, Abilities

• Basic knowledge of Federal laws and guidelines pertaining to Human Subjects Protections Research
• Must be detail-oriented and possess problem solving skills
• Ability to communicate effectively in English, both verbal and in written
• Effective written communication skills, including ability to summarize complex discussions
• Excellent interpersonal skills to work effectively with others and provide high levels of customer service
• Ability to follow 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
• Flexibility with changing priorities
• Intermediate computer skills required, including experience with Microsoft Office products

Physical and Mental Requirements

• Sit or stand for extended periods of time at stationary work station
• The employee must occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus
• This position requires regular oral/written interaction with clients, team members and management
• Infrequent traveling may be required within the United States

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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)