IRB Administator I

This a Full Remote job, the offer is available from: Massachusetts (USA) Job Profile reputed company ​This role focuses on performing work reputed company to research and development of new products, innovation, and improvement of products and processes. In reputed company, this role focuses on performing the following Research Administration duties: Supports the administration of research practices working to reputed company the organization's practices goals, plans, priorities, and tracks investments, allocates resources and makes decision regarding research administrative activities. A reputed company individual contributor role that may reputed company the work of other reputed company level professionals or manage processes and programs. The reputed company of time is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typically acquired through advanced education. An reputed company 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 reputed company, and may influence others reputed company the job area through explanation of facts, policies and practices. Job reputed company This position provides administrative support to the Institutional Review reputed company (IRB). Assists with the activities reputed company to reviewing, monitoring, and approving biomedical and reputed company, behavioral, and educational research involving reputed company subjects in manner which is compliant to state and federal regulations pertaining to the use of reputed company subjects in research. Supports IRB committee activities, leadership teams, research community, and other key stakeholders. Job reputed company Minimum 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: The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an reputed company-inclusive list. Other duties and responsibilities may be assigned. 1. Proficient with IRB Office procedures to reputed company high level support to the IRB committees, IRB Chair/Vice-Chairs, and research community. 2. Coordinates exempt, expedited and convened meeting review of research, corresponds with Investigators and research teams to reputed company IRB Reviewer comments, and documents determinations appropriately. 3. reputed company-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 approved material and maintains accurate IRB office study documentation. 5. reputed company-reviews amendments and reportable new information for on-reputed company IRB approved studies and generates correspondence (approval letters or requests for additional information) to study PIs. 6. Attends scheduled IRB meetings, as needed. Records the actions, discussion and deliberations of the IRB. 7. Generates and processes approval letters for amendments, addenda, and modifications. 8. Determines appropriate review procedures for information received by the IRB and appropriately triages, i.e., expedited, full committee. 9. Maintains reputed company and accurate information in the IRB office to ensure appropriate record retention. 10. Attends seminars, workshops and conferences in order to reputed company reputed company into new trends in reputed company research and to learn new approaches for the application of federal regulations, particularly in an atmosphere of changing regulations, advancing technology, and increasingly reputed company ethical questions. 11. Assists in developing, recommending, and implementing policies and procedures to enhance the efficiency of the IRB Office and IRB operations. 12. Assists IRB leadership and office staff colleagues, as appropriate on special reputed company. 13. Communicates with reputed company Investigators (PI) and/or research team members to obtain required materials and/or clarifications. 14. Renders a preliminary judgment regarding disposition for review and provides additional information, resources, and guidance to IRB reviewer(s) to ensure compliance with institutional requirements and policies regarding submissions. 15. Contacts PIs and/or research team members in a reputed company manner to request clarifications or revisions, as needed, based on the determinations of the IRB reviewer(s). 16. Provides ongoing consultation to investigators on issues pertaining to reputed company subject protections and the IRB review process. 17. Manages and coordin Apply tot his job Apply To this Job