"Clinical Research Regulatory Coordinator"

Job Description

Clinical Research Regulatory Coordinator

Wright State University

EEO Statement: Wright State University is an equal opportunity employer.

Faculty Rank or Job Title: Clinical Research Regulatory Coordinator

Job Category: Administrative (exempt/non-exempt)

Department: Research Affairs-BSOM

EEO number: 25P118

Position FTE: 100% FTE

Minimum Annual or Hourly Rate: $47,000

Salary Band: UC S04

Job Summary/Basic Function
The Clinical Research Regulatory Coordinator will function in a multi-faceted role and will be required to interact with Principal Investigators, study sponsors, clinical research coordinators, contract research organizations and hospital/medical office personnel. Effectively provide regulatory support services for assigned clinical research trials within Wright State University (WSU) and Premier Health (PH). Works to ensure compliance with Federal, State, Institutional and facility regulations and policies, as well as those specific to internal standard operating procedures and all applicable Institutional Review Board (IRB) policies.

Minimum 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
50%

• 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.

Essential Functions and percent of time (cont'd)
25%

• Collaborate closely with study team colleagues and Investigators for effective launch and execution of clinical trials.
• Serve as a direct regulatory contact for study sponsor and monitors, and other healthcare contacts and departments.
• Provide support with regulatory education and navigation of electronic systems and training tools to sub investigators, appropriate units and departments, and other study team members as assigned.
• Work independently while in a team environment, guided by regulations.

15%

• Maintain accurate records as defined in approved protocols and enter data on appropriate forms or into databases as required.
• Record effort, start-up activities, and all submissions for metric-tracking as assigned.

10%

• Completes special projects and reports as assigned.

Non-Essential Functions and percent of time

Working Conditions
Travel to various facility locations within the WSU campus and Premier Health Network, as well as other clinics/physician’s offices may be required.Special contract position. Special contract terms and conditions of employment apply.To preserve the safety and security of the campus community and to maintain the integrity of university operations, it is the policy of Wright State University making an employment offer contingent on various background checks, such as a criminal record, credit history when job related and/or education verifications. Additionally, an administrative review shall be conducted whenever the university learns that an employee is charged with or convicted of a crime (except for minor vehicle violations). Frequently asked questions related to background checks may be found on the Human resources website at http://www.wright.edu/human-resources.Effective July 1, 2017, per Policy 7230 Wright State University is tobacco-free. Tobacco use, including the sale, advertising sampling and distribution of tobacco products and tobacco related items is prohibited in all university facilities, on all university owned or leased grounds, university owned or operated residence halls and apartments, and at all university sponsored events regardless of location. Tobacco use is also prohibited in all university vehicles or on any equipment owned, leased or operated by Wright State University. This policy applies to anyone on campus including students, faculty, staff, visitors, consultants, vendors, patients, volunteers, and contractor employees.

Special Instructions to Applicants

First Consideration Date: 02/19/2025

Closing Date:

Open Until Filled: Yes

To apply, please visit: https://jobs.wright.edu/postings/21173