Affirmative Action No.:: 25P118

First Consideration Date:: 02/19/2025

Department:: Research Affairs-BSOM

Position FTE::

Minimum Annual or Hourly Rate: $47,000

Job Purposes::

Required Qualifications::

• Bachelor's degree with 2-years of related experience.
• Excellent verbal, written and interpersonal communication skills.
• Professionalism and effective time management skills to prioritize responsibilities, maintain project timelines, and trouble shoot potential delays.
• Strong organizational skills and attention to detail.

Preferred Qualifications::

• One year of clinical research research experience.
• Demonstrated knowledge and insight into legal and regulatory matters concerning clinical research.
• Familiarity with investigational drug and device trials and associated regulations.
• Proficiency with Microsoft Office suite of programs.

Essential Functions and percent of time::

• Gather the required information, prepare, and submit IRB submissions for sponsor-generated clinical research trials to all corresponding IRBs in a timely manner.
• Under direction, prepare appropriate changes in staff, amendments/modifications to protocols, subject materials, advertisements, etc.
• Complete annual progress review reports.
• Collect all necessary signatures from clinical research staff.
• Draft informed consent forms and other essential regulatory documents as assigned.
• Execute submissions through their completion and approval letter in-hand, including reminders and follow-up as needed, alerting Director when/if an IRB, study team member is unresponsive or lagging in timeliness for regulatory compliance, including training and requests for signatures.
• Work collaboratively as an integral research team member within a cross-functional environment.
• Apply an understanding of research regulations, ethics and guidelines to daily work. Act as a resource providing regulatory support to the clinical research team.
• Work daily in an audit-ready manner.
• Maintain an understanding of all Food and Drug Administration (FDA)/ International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) rules and regulations, as well as those of the WSU and PH Institutions, and all applicable IRBs.

Working Conditions::

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About Wright State University

Wright State University serves nearly 18,000 students and offers more than 230 undergraduate, graduate, doctoral, and professional degree programs through eight colleges and three schools. Located in the city of Fairborn in Greene County, Ohio, Wright State is conveniently situated adjacent to Wright-Patterson Air Force Base and is less than 10 miles from downtown Dayton. One of our eight colleges, Wright State University–Lake Campus, is a university-operated regional campus on the shores of Grand Lake St. Marys in Celina, Ohio. The Wright State alumni community is more than 109,000 strong. For more information please visit www.wright.edu.

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