IRB Administrator I

Job ProfileSummary​This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes.In addition, this role focuses on performing the following Research Administration duties: Supports the administration of research practices working to achieve the organization's practices goals, plans, priorities, and tracks investments,allocatesresources and makes decisionregardingresearch administrative activities.A professional individual contributor role that may direct the work of otherlower levelprofessionals or manage processes and programs.The majority oftime is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typicallyacquiredthrough advanced education.An experienced level role that applies practical knowledge of job area typically obtained through advanced education and work experience.Works independently with general supervision, problems faced are difficult but typically not complex, and may influence others within the job area through explanation of facts,policiesand practices.Job OverviewThis positionprovidesadministrative support to theInstitutional Review Board (IRB).Assistswith the activities related toreviewing,monitoring, and approvingbiomedical and social, behavioral, and educational research involving human subjectsinmanner which is compliant to state and federalregulationspertaining tothe useof human subjects in research. SupportsIRB committeeactivities, leadership teams,research community,and other key stakeholders.Job DescriptionMinimum Qualifications:1.Bachelor’s Degree.2.Two (2) years of experience in a clinical research environment or IRB Office.Preferred Qualifications:1.Advanced Degree.2.Five (5) years of experience in a clinical research environment or IRB Office.Duties and Responsibilities:Theduties and responsibilities listedbeloware intended to describe the general nature of workandare not intended to be an all-inclusive list.Other dutiesand responsibilitiesmay be assigned.1.Proficient with IRB Office procedures toprovidehigh level support to the IRB committees, IRB Chair/Vice-Chairs, and research community.2.Coordinates exempt,expeditedand convened meeting review of research, corresponds with Investigators and research teams to relay IRB Reviewer comments, and documents determinations appropriately.3.Pre-reviews IRB applications for consistency, completeness, and compliance with federal and state regulations and institutional policies before review by the IRB or designated IRB Reviewer.4.Prepares IRB approvedmaterialandmaintainsaccurateIRB office study documentation.5.Pre-reviews amendments and reportablenew informationfor on-going IRB approved studies and generates correspondence (approval letters or requests foradditionalinformation) to study PIs.6.Attends scheduled IRB meetings, as needed. Records the actions,discussionand deliberations of the IRB.7.Generates and processes approval letters for amendments, addenda, and modifications.8.Determinesappropriate reviewprocedures for information received by the IRB andappropriatelytriages, i.e.,expedited, full committee.9.Maintainscurrent andaccurateinformation in the IRB office to ensureappropriate recordretention.10.Attends seminars,workshopsand conferencesin order togain insight intonew trendsin human research and to learnnew approachesfor the application of federal regulations, particularly in an atmosphere of changing regulations, advancing technology, and increasingly complex ethical questions.11.Assists in developing, recommending,and implementing policies and procedures to enhance the efficiency of the IRB Office and IRB operations.12.AssistsIRB leadership and office staff colleagues, asappropriate onspecial projects.13.Communicateswith Principal Investigators (PI) and/or research team members to obtain required materials and/or clarifications.14.Rendersa preliminary judgmentregardingdisposition for review andprovidesadditionalinformation, resources, and guidance to IRB reviewer(s) to ensure compliance with institutional requirements and policiesregardingsubmissions.15.ContactsPIs and/or research team members in a timely manner to request clarifications or revisions, as needed, based on the determinations of the IRB reviewer(s).16.Providesongoing consultation to investigators on issuespertaining tohuman subject protections and the IRB review process.17.Manages and coordinates continuing education program about human subject protections for IRB members, IRB staff and investigators.18.Presents education sessions and seminars, etc., for the research community.19.Leads in the development and implementation of job-related policies and procedures to enhance efficiency of office operations.20.Assists with internal IRB audits.21.Leads development of web-based materials that support the IRB, including educational materials,policiesand procedures.22.Providespositive and effective customer service that supports IRB operations.23.Mentors and trains IRB Office colleagues, as needed.24.Maintains collaborative team relationships with peers and colleagues in order to effectively contribute to the working group’s achievement of goals, and to help foster a positive work environment.25.Notifies PI, as needed, of incomplete research applications that would delay the IRB review process.Physical Requirements:1. This islargely asedentary role, which involves sitting most of the time, but may involve movements such as walking, standing, reaching, ascending/descending stairs, and operating office equipment.2. Frequentlyrequiredto speak, hear, communicate, and exchange information.3. Ability to see and read computer displays, read fine print, and/or normal type size print and distinguish letters,numbersand symbols.4. Requires manual dexterity using fine hand manipulation tooperatecomputer keyboard.Skills & Abilities:1.Excellent verbal and written communication skills.2.Excellent customer service skills.3.Ability to stay calm in high pressure situations.4.Ability to understand and share the feelings of others.5.Ability to show initiative, work autonomously, and to organize oneself.6.Ability to work in and thrive within a team environment.7.Ability to adapt to changing job demands.8.Ability to make reasoned judgments that are logical and well-thought out.9.Ability todemonstratethoroughness and accuracy whenaccomplishinga task.10.Strong organizational capabilities.11.Ability toestablishrapport, create a relationship of trust,and build collaborative relationships.12.Ability to respond to situations inan appropriate manner; behaving and knowing when to act according to the circumstances; professional discretion.13.Ability to navigate comfortably with differentcomputersoftware and applications.14.Knowledgeable about federal and state regulations as well as institutional policies related to the protection of human subjects.15. Ability to prioritize multiple competing tasks.At Tufts Medicine, we want every individual to feel valued for the skills and experience they bring. Our compensation philosophy is designed to offer fair, competitive pay that attracts, retains, and motivates highly talented individuals, while rewarding the important work you do every day.The base pay ranges reflect the minimum qualifications for the role. Individual offers are determined using a comprehensive approach that considers relevant experience, certifications, education, skills, and internal equity to ensure compensation is fair, consistent, and aligned with our business goals.Beyond base pay, Tufts Medicine provides a comprehensive Total Rewards package that supports your health, financial security, and career growth—one of the many ways we invest in you so you can thrive both at work and outside of it.Pay Range:$47,924.24 - $59,894.75