Clinical Regulatory Coordinator II

TriHealth•Cincinnati, OH

9d•Onsite

About The Position

Come join TriHealth as a Clinical Regulatory Coordinator II! TriHealth offers a mission-driven environment where regulatory professionals can make a meaningful impact on the integrity and success of clinical research. As a Clinical Regulatory Coordinator II, you play a central role in ensuring every study meets the highest standards of compliance, ethics, and patient protection. You’ll serve as the primary regulatory contact across the full clinical trial lifecycle - preparing submissions, managing IRB communications, maintaining essential documents, and supporting internal and sponsor audits. Your expertise directly strengthens the quality, safety, and credibility of the research that shapes patient care across our system. What sets TriHealth apart is our commitment to supporting professionals who take pride in precision, collaboration, and purpose-driven work. You’ll partner closely with investigators, research nurses, sponsors, and cross-functional teams in an environment that values initiative, problem-solving, and continuous learning. TriHealth is consistently recognized as a great employer because we invest in our people, foster a culture of respect and teamwork, and empower you to grow your career while contributing to research that truly matters. This is a place where your regulatory expertise is not only valued - it’s essential to advancing healthcare in our community. Apply today and grow your career with a team that truly values you.

Requirements

Bachelor's Degree
Equivalent experience accepted in lieu of degree
Medical terminology
Proficient in Microsoft Office
Demonstrated knowledge & understanding of human research policies, regulations, procedures & standards according to HIPAA, IRB, FDA, ICH, & GCP guidelines, Sponsor regulatory requirements
1-2 years’ experience Professional

Nice To Haves

Exceptional communication skills, both verbal and written, are required to interact with a variety of customers, both internal and external.
The ability to multi-task and remain organized in a high-volume clinical trial setting with keen attention to details is required.
Goal oriented person who takes initiative is self-motivated and a creative problem solver.

Responsibilities

Collaborates with the study team and sponsors in the preparation and submission of applications and documents based on local and central/commercial IRB recommendations of new studies, study amendments, and continuing reviews.
Proficient in the tracking of all IRB approvals. Assures IRB/regulatory compliance in facilitating communication between study sponsor, IRB, principal investigator, and study subjects as indicated.
Assures compliance with standards and deadlines in notification of subject registration, enrollment, and decision to end participation in study when indicated.
Follows standard procedures and meets deadlines for submissions of progress reports and external safety data.
Works with clinical team to assure compliance with IRB/regulatory deadlines for reporting deaths, adverse events and serious adverse events with study subjects.
Ensure timely review and reporting of Unanticipated Problems.
Maintains status and submits investigator and research staff training and credentialing for research as required by study sponsors and requirements specific to the department and collaborative departments (i.e. CHI).
Creates and maintains filing system for studies and performs periodic monitoring for file completeness.
Locates needed documents (i.e. study records for both open and closed studies) accurately and confidentially. Maintains the regulatory files and ensures appropriate version control is in place.
Updates databases for reporting requirements and prepares reports related to regulatory status for team meetings.
Independently gathers information from supportive departments from both within and outside of the institution as indicated and required by the department.
Works with the clinical research team in the development of department or study specific templates for data capture, education, marketing materials, and miscellaneous data management as designated by the supervisor or manager.
Inputs and evaluates metrics tracking to monitor departmental and associate performance and time expenditures.
Acts as the primary department contact for all regulatory matters. Independently prepares and submits all regulatory documents required by the sponsor.
Communicates with the IRB and Sponsor on behalf of the study team regarding regulatory management.
Monitors email and sponsor websites/portals to ensure that regulatory documents are up to date and implemented in a timely fashion.
Serves as the primary contact when coordinating and communicating with investigators and research staff.
Performs clinical and logistical review of protocols and applies this knowledge to regulatory job requirements.
Set-ups and conducts of all phases of clinical trial research as needed, including but not limited to the review and preparation of new study submission applications (internal administrative review and IRB submissions). Independently reviews and prepares site informed consent/HIPAA forms.
Educates self with respect to research topic of studies.
Is prepared for discussion/communication with manager, supervisor, research nurses and investigator regarding study project progress.
Attends department meetings and gives creative, constructive input related to project(s) and proposal(s).