RESEARCH ASSISTANT I

Affiliate Name: Brigham & Women's Hospital
Job Category: Research
Department: BWH TIMI
Shift: Days
Hours/Week: 40
Job Type: Regular
Employment Type: Full TimeResponsibilities:
Receives, records, and reviews FDA filing documents for accuracy in order to submit to Sponsor for site activation into the assigned clinical trial(s). On the basis of a thorough understanding of the Regulatory (FDA) and Sponsor-specific guidelines, ensures completeness and accuracy according to guidelines. Ensures accurate and timely submission of regulatory filing documents.Receives telephone calls and correspondence from Principal Investigators and Research Coordinators in North America and Europe. Responds and troubleshoots in accordance with a broad understanding of each assigned clinical trial. Has a detailed working knowledge of all aspects of each ongoing study as well as those in the developmental stages. On the basis of this thorough understanding, provides answers to a wide range of inquiries pertaining to study-related matters.Maintain databases and tables to track regulatory documents, numbered memoranda, and contract information.Responsible for accurate and timely preparation of documents such as tables, conference or meeting minutes, operations reports, protocols, etc. Types, edits, formats, and proofreads all documents for content and accuracy. Understands and ensures documents are prepared according to various requirements.Types letters, memoranda, newsletters, posters, study aids. Ensures proper distribution to outside Principal Investigators, Research Coordinators, Core Lab Directors, Operations Committees, and various study personnel in accordance with FDA and/or Sponsor regulations.Assists with mass mailings to all participating hospitals under the guidance of the appropriate team leader and/or project manager. Ensures all regulatory memoranda are distributed in a timely manner and as indicated in trial-specific Standard Operating Procedures.Assists with the organization of meetings and investigator training sessions. This includes preparation of study aids and Manuals of Operation, ensuring all materials are updated and distributed to participating sites as necessary in accordance with regulatory requirements. Also includes coordination of caterer, hotel accommodations, conference rooms, audiovisual needs, and signing contracts with vendors as required. Travel to meeting sites throughout the U.S. may be required.May be assigned special projects which pertain to unique ongoing trials.Maintains department service standards, with particular attention to personal/behavioral, staff teamwork, and customer-staff interaction guidelines.Provides back-up support to Director, Administrator, and Project Managers as required.Performs other duties as required and as appropriate.
REQUIREMENTS
Computer literacy (MS Office Suite)Careful attention to detailGood interpersonal and communication skillsExcellent organizational skillsAbility to work independentlyAbility to demonstrate professionalismBA or BS