Clinical Research Regulatory Specialist I, Department of Neurology & Rehabilitation Services, Stroke

Current UC employees must apply internally via
SuccessFactors

Next Lives at the University of
Cincinnati

Founded in 1819, the University of Cincinnati ranks among
the nation’s best urban public research universities. Home to more
than 53,600 students, 12,000 faculty and staff, and over 360,000
living alumni, UC, a Carnegie 1 institution, combines research
prowess with a physical setting The New York Times has called “the
most ambitious campus design program in the country." UC's momentum
has never been stronger as the anchor of the Cincinnati Innovation
District, the oldest cooperative education (co-op) program in the
country with students earning $94 million annually through paid
experiences, an academic health system, and as a member of the Big
12 Conference. The university contributes $10.6 billion in economic
impact to the city and $22.7 billion to the state of Ohio. At UC,
next is all of us. Learn more at uc.edu.

UC is a mission-driven organization where we are committed
to student success and positively transforming the community
through scholarship and service. We thrive on innovation, making an
impact, and fostering an environment where staff and faculty are
key contributors to UC’s success.

Job Overview

As one of the oldest medical schools in the country, the
University of Cincinnati College of Medicine (COM) has a reputation
for training best-in-class health care professionals and developing
cutting-edge procedures and research that improves the health and
clinical care of patients. In partnership with the UC Health
academic healthcare system and Cincinnati Children’s Hospital
Medical Center, College of Medicine’s doctors and faculty are
transforming the world of medicine every day. The Department of
Neurology & Rehabilitation Medicine is a top-tier department
with world-renowned faculty and staff. With world-class research,
teaching and medical practice opportunities, why not choose the
University of Cincinnati College of Medicine?

UC is one of the largest employers in the Cincinnati
region, employing over 15,000 full-time and part-time faculty,
staff and student workers.

Founded in 1947, the UC Department of Neurology and
Rehabilitation Medicine is revolutionizing medicine by connecting
discovery and education to world-class care in neurological
diseases. Our vision is to be the model organization that
integrates neurologic clinical care, research and
education.

The University of Cincinnati, College of Medicine,
Department of Neurology and Rehabilitation Medicine is seeking a
full-time Clinical Research Regulatory Specialist I. This person
coordinates and provides administrative support for clinical
research regulatory activities and initiatives including reviewing
documents, applications, and reports and ensuring compliance with
internal and external regulatory frameworks. They also serve as a
liaison for designated research protocols, programs or units with
internal and external stakeholders such as IRBs, industry sponsors,
contracting offices, and regulatory agencies. They will apply their
skills to a broad range of different types of studies, navigate
resources, and identify issues needing escalation. The position can
be considered a hybrid role. Weekly time spent on site is near
University of Cincinnati main medical campus in Clifton,
Ohio.

Essential Functions

• Prepares and submits protocol specific documentation to

regulatory agencies and internal or external stakeholders
including: research protocols, informed consent forms, or other
similar documents necessary for research start-up or maintenance or
close-out.

• Serve as liaison for questions/issues for designated

research protocols and performs submissions to Institutional Review
Boards (IRBs) including initial submissions, continuing reviews,
amendments, reportable events, and/or closure.

• Address all regulatory issues involving research

protocols; interpret, analyze and apply federal, state, and local
regulations, along with University rules and regulations, to ensure
ethical research practices are followed; report suspected or known
instances of noncompliance with University or federal
regulations.

• Maintains all regulatory documentation within existing

systems (i.e., Complion) and secure document storage, including
those that are complex in nature (e.g., procedural and
interventional studies).

• Comprehends, interprets, and applies regulations and

legislation regarding the protection of human subjects. These
include regulations under federal policies, FDA, and other
compliance agencies or directive.

• Assist with activities related to development and

execution of research agreements relating to the conduct of
research activities.

• Prepares for, coordinates, and actively participates in

site visits; communicates effectively with sponsors and/or contract
research organizations (CROs).

• Interacts with IRB and sponsor contacts with close

supervision.

• Prepares and submits documentation to regulatory agencies

with close supervision.

• Perform related duties based on departmental need. This

job description can be changed at any time.

Required Education

• Bachelor’s Degree

Required Trainings/Certifications

• N/A

Required Experience

• 1-2 years of relevant experience

Physical Requirements/Work Environment

• Sitting - Continuously
• Hearing, listening - Continuously
• Talking - Continuously

Compensation and Benefits

UC offers an exceptional benefits package designed to
support your well-being, financial security, and work-life
balance. (UC
Benefits) Eligibility may vary by position and FTE
status. Highlights include:

Comprehensive Tuition
Remission

UC provides tuition remission for you and your eligible
dependents, covering tuition costs for nearly all undergraduate and
graduate programs offered by the university.

Robust Retirement Plans

As a UC employee, you won’t contribute to Social Security
(except Medicare). Instead, you’ll choose between state pension
plans (OPERS, STRS) or an Alternative Retirement Plan (ARP), with
UC contributing 14–18% of your salary based on position.

Real Work-Life Balance

UC prioritizes work-life balance with a generous time-off
policy, including:

Vacation and sick time

11 paid holidays and additional end-of-year paid time off
(Winter Season Days)

6 weeks of paid parental leave for new parents

Additional Benefits Include:

• Competitive salary based on experience
• Comprehensive health coverage (medical, dental, vision,

prescription)

• Flexible spending accounts & wellness

programs

• Professional development & mentorship

opportunities

To learn more about why UC is a great place to work,
please visit our Careers
Page.

UC is an E-Verify employer. If hired into this position,
you will be required to provide satisfactory proof of employment
eligibility by providing acceptable, original forms of
identification for employment verification via the Federal I-9
employment verification process. Click here
for a list of acceptable documents.

Important: To apply you must
create a profile and submit a complete job application through the
UC applicant portal. We
are unable to consider “easy apply” applications submitted via
other websites. For questions about the UC recruiting process or to
request accommodations with the application, please contact UC HR
at jobs@uc.edu.

Equal Opportunity Employer. Building a workplace
where all qualified applicants will receive consideration for
employment, including Individuals with Disabilities and Protected
Veterans.

REQ: 104384