Research Assistant

Job Description Summary

The research assistant position is an entry‑level, full‑time role for professionals who would like to gain clinical research experience. Ohio Health 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, policies, work methods and procedures.

Manages complex administrative tasks in support of research administration and clinical trials, including but not limited to screening patients, entering/abstracting data, processing research specimens, maintaining clinical trial inventory and documentation (such as specimen kits, long term storage/archival), document filing, assisting with basic IRB submissions, scheduling and coordinating project meetings and assisting with other core administrative activities in support of research operations.

Based on performance and demonstrated competency, OHRI research assistants who do not possess a bachelor’s degree may be eligible to apply for a clinical research coordinator, regulatory coordinator or other applicable position within OHRI.

• 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 the 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.
• As a High Reliability Organization (HRO), responsibilities require focus on safety, quality and efficiency in performing job duties.

The job profile provides an overview of responsibilities and duties and is not intended to be an exhaustive list and is subject to change at any time.

High School or GED (Required)

Clinical Research, Project Management, Research Administration, Life Sciences, Pharmaceutical sciences, Clinical Laboratory Technology, public health, health policy, health economics, or other health sciences.

Exceptional organization and time management skills. Detail-oriented person with the ability to work…