Research Assistant (Regulatory)

We are more than a health system. We are a belief system. We believe wellness and sickness are both part of a lifelong partnership, and that everyone could use an expert guide. We work hard, care deeply and reach further to help people uncover their own power to be healthy. We inspire hope. We learn, grow, and achieve more – in our careers and in our communities. Job Description Summary The research assistant position is an entry-level, full-time role for professionals who would like to gain clinical research experience. OhioHealth Research Institute (OHRI) is a centralized department that fosters medical treatments and enhanced patient experiences through clinical trials, scholarly activity and other programs. The purpose of this position is to provide coordination and support for OHRI Research Operations as it relates to therapeutic/interventional clinical trials, academic research, regulatory, quality assurance and other research operations roles as needed. This position is responsible for assisting research coordinators, regulatory consultants, research specialists, research activation coordinator and other research personnel (as determined by research leadership) in regard to specific team/project activities with the goal of maximizing efficiency of management control systems, programs, work methods and procedures. Responsibilities And Duties Supports research staff with execution of high acuity/enrolling clinical trials. This includes but is not limited to data entry, processing and shipping of laboratory samples and activating and closing out research studies. Extracts and records physical findings, laboratory data and other details essential to each study onto required data collection forms/software applications within the designated time period. Assists research staff with reporting adverse events and protocol violations / deviations to the study sponsor and investigator to ensure the health, safety and welfare of the participant. Participates in protocol meetings to review study-related procedures and visit flow. Accurately records and extracts data from source documentation onto required data collection forms (paper or electronic) in a timely manner. Maintains accurate and timely source documentation. After study closeout visits, prepares study documents for archiving. Supports OHRI Regulatory team in maintaining investigator credentials and other supporting documents as needed. Interacts and maintains liaison with colleagues, investigators, staff and outside/community agencies in facilitating department objectives. Assists with scheduling site monitor visits for clinical teams as needed. Provides administrative support for shipping logistics, temperature monitoring logs and tracking metrics as needed. Assists in audit preparedness activities for OHRI. Assists with maintaining study records according to sponsor and/or regulations. Assists in development of reporting metrics. Assists with recording meeting minutes and timely distribution. Attends relevant training courses on policy and compliance. Other administrative duties as assigned. Minimum Qualifications High School or GED (Required) Specialized Knowledge Exceptional organization and time management skills. Detail-oriented person with the ability to work independently on multiple tasks. Ability to understand and communicate requirements to others. Excellent verbal, interpersonal and written communication skills. Strong computer skills with high level of proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint) and database applications. High level of initiative and ownership with the ability to self‑motivate. Works well independently and in team settings. Work Shift: Day Scheduled Weekly Hours: 40 Department: Research Administration Equal Employment Opportunity OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all persons in all aspects of the associate‑employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment. #J-18808-Ljbffr OhioHealth