Clinical Regulatory Coordinator II

Job Description

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.

Location:

• Good Samaritan Hospital Lab at 375 Dixmyth Avenue, Cincinnati, OH 45220

Work Schedule:

• Full-Time (80 hours bi-weekly)
  
  • In Office Work Required
• Day Shift
• No Weekend, Holiday or On Call Commitment

Benefits:

TriHealth offers aa comprehensive benefits package including medical, dental, vision, paid time off, retirement plans, and tuition reimbursement. Please view our benefits page

Job 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

Job Overview:

The Research Regulatory Coordinator II serves as an integral part of the research team and is the primary contact for all regulatory activities of research studies throughout the clinical research life cycle of assigned protocols. The individual should exemplify the TriHealth mission, vision and values and acts in accordance with TriHealth, IRBs, and FDA policies and procedures. This position supports the set-up and conduct of all phases of clinical trial research as needed, including but not limited to the review and preparation of new study submission applications, site informed consent/HIPAA forms, collection and maintenance of regulatory documents, preparation and submission of local and central/commercial IRB applications and modifications, tracking of IRB approvals, completion of continuing review reporting, and preparation and assistance with internal and sponsor monitoring visits. Perform clinical and logistical review of protocols and apply knowledge to job requirements.

Job 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).

Other Job-Related Information:

• 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.

Working Conditions:

TriHealth SERVE Standards and ALWAYS Behaviors
At TriHealth, we believe there is no responsibility more important than to SERVE our patients, our communities, and our fellow team members. To achieve our vision and mission, ALL TriHealth team members are expected to demonstrate and live the following:


Serve: ALWAYS...
• Welcome everyone by making eye contact, greeting with a smile, and saying "hello"
• Acknowledge when patients/guests are lost and escort them to their destination or find someone who can assist
• Refrain from using cell phones for personal reasons in public spaces or patient care areas

Excel: ALWAYS...
• Recognize and take personal responsibility to address and recover from service breakdowns when a customer's expectations have not been met
• Offer patients and guests priority when waiting (lines, elevators)
• Work on improving quality, safety, and service


Respect: ALWAYS...
• Respect cultural and spiritual differences and honor individual preferences.
• Respect everyone's opinion and contribution, regardless of title/role.
• Speak positively about my team members and other departments in front of patients and guests.

Value: ALWAYS...
• Value the time of others by striving to be on time, prepared and actively participating.
• Pick up trash, ensuring the physical environment is clean and safe.
• Be a good steward of our resources, using supplies and equipment efficiently and effectively, and will look for ways to avoid waste.

Engage: ALWAYS...
• Acknowledge wins and frequently thank team members and others for contributions.
• Show courtesy and compassion with customers, team members and the community