Research Associate I

Purpose of Role / Job Summary The Research Associate I assists the Study Director team with the planning, execution, data tabulation, and reporting of Good Laboratory Practices (GLP) and non-GLP Toxicology, Medical Device and Pharmacokinetic studies. To perform this job successfully, an individual must have the knowledge, skills, and abilities identified below and perform each essential duty and responsibility satisfactorily, either with or without reasonable accommodation. The below is intended to describe the general content of and requirements for this job's performance and is not to be construed as an exhaustive statement of essential functions, responsibilities or requirements. Key Accountabilities Responsible for the preparation of study notebooks. Creates and reviews raw data collection forms for adherence to protocol and clarity/efficacy prior to study start. Assists with the review of study event schedules as needed in accordance with the study protocol. Assists the Study Directors in coordination and oversight of study conduct and ensuring proper raw data collection according to the study protocol and applicable standard operating procedures (SOPs) with minimal supervision. Participates in scribing and data collection for study activities both in an electronic data capture system, and on raw data forms. Assists the study director with inventory and tracking of Test and Control devices and/or materials. Downloads electronic data reports, compiles raw data packages, analyzes study data and creates data tables and graphs. Assists with preparation and review of study reports. Performs quality control (QC) of tabulated data. Prepares or assists in the preparation of internal and/or contracted sub-reports as required. Assists with archiving of finalized study data. Efficiently and effectively communicates to supervisor, study directors, and study personnel when issues arise that impact project progress or timing. Provides peer review of study protocols and associated amendments, SOPs, reports, animal use activity and other documentation. Other Follows all SOPs and other applicable laboratory or company policies and procedures. Maintains confidential information. Supports and participates in company initiatives as directed. Performs periodic review of all applicable SOPs to ensure accuracy and confirm procedures are being performed according to SOPs. Participates in SOP writing, review, and revision, as needed. Completes training requirements as assigned and maintains appropriate training documentation. Maintains compliance and adheres to all safety regulations, policies, and procedures and good documentation practices. Maintains a basic knowledge and ensures compliance with GLP, United States Department of Agriculture (USDA), Association of Assessment and Accreditation of Laboratory Animal Care (AAALAC), Office of Laboratory Animal Welfare (OLAW), and other applicable regulations. Interacts with clients, other employees, and the community in a professional manner. Performs other duties as assigned. Critical Success Factors Good organizational skills and detail oriented. Excellent communication and interpersonal skills with ability to work with personnel at all levels of the organization. Ability to work independently as well as a team environment. Ability to multi-task and prioritize tasks in a high energy, fast paced environment. Exhibits accuracy and adaptability performing laboratory operations, some of which may be difficult and/or non-routine. Proficient in the use of a computer to compile and maintain simple data, spreadsheets, checklists and reports for records and inventory, utilizing the appropriate software. Exhibits an aptitude for quality, an eye for detail, the ability to follow written instructions and work with minimal supervision. Working knowledge and awareness of general laboratory procedures. Ability to follow detailed instructions with a sense for scientific method. Minimum Requirements Associate degree, or equivalent, in biology or life science. One year experience in a laboratory, contract research organization, or similar research setting. Excellent written and verbal communication skills. Familiarity with writing and interpreting scientific reports and data. Demonstrated proficiency using Microsoft Excel and other Office Suite products and Adobe Acrobat. Ability to quickly learn new computer software systems. Preferred Bachelor's degree in biology or life science. Working Conditions & Physical Requirements The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. (The phrases \"occasionally,\" \"regularly,\" and \"frequently\" correspond to the following definitions: \"occasionally\" means up to one-third of workin #J-18808-Ljbffr