Job ID85635LocationAurora, ColoradoFull/Part TimeFull-TimeRegular/TemporaryRegularWhy Work at Children's.Here, it's different. Come join us.
Children's Hospital Colorado has defined and delivered pediatric healthcare
excellence for more than 100 years.
Here, the nation's brightest nurses, physicians, scientists,
researchers, therapists, and care providers are creating the future of
child health. With an optimist's outlook, a trailblazing spirit, and a
celebrated history, we're making new strides every day.
We've been Magnet-designated four times by the American Nurses Credentialing
Center and are consistently recognized among the best of the best pediatric
hospitals with #1 rankings in Colorado and the region by U.S. News & World
Report.
As a national leader in pediatric care, we serve children and families from
all over the nation. Our System of Care includes four pediatric hospitals,
11 specialty care centers, 1,300+ outreach clinics and more than
10,000 healthcare professionals representing the full spectrum of pediatric
care specialties.
Here, we know it takes all of us, every role, to deliver the best
possible care to each child and family we treat.
That's why we build our teams toward a foundation of equity in access,
advancement, and opportunity. We know teams of individuals with different
identities and backgrounds can nurture creativity and innovation. We know we
can see, treat, and heal children better when our team reflects the
diversity of our patient population. We strive to attract and retain diverse
talent because we know a truly inclusive and equitable workforce will help us
one day realize our most basic calling: to heal every child who comes
through o
A career at Children's Colorado will challenge you, inspire you, and
motivate you to make a difference in the life of a child. Here, it's
different.Job OverviewThe Clinical Research Regulatory Specialist is responsible for the management
of clinical research protocol documents and activity from initial submission
through study closure. The primary focus is on the development,
submission, maintenance, filing and reporting of regulatory documents
while achieving and maintaining compliance with all internal, external and
federal policies and regulations that apply to research involving human
subjects. Provides regulatory guidance and direction to all members of the
research team at Children's Hospital Colorado to ensure compliance with all
applicable policies, procedures and regulations.
This position will be within the centralized research infrastructure at
Children's Hospital Colorado, within the Research Institute. This position
will support several service lines within the institution.Additional InformationDepartment Name: Research Institute
Hours per week: 40, eligible for benefits
Shift: Monday - Friday, 8am to 4:30pm. Work hours may vary due to
department needs. This is a hybrid position.QualificationsEducation: Bachelor's degree in a related field is required.
Experience: Minimum of three (3) years of related experience is required.
Equivalency: Minimum of seven (7) years of related experience may be
considered in lieu of minimum requirements.ResponsibilitiesPOPULATION SPECIFIC CARE
No direct patient care.
ESSENTIAL FUNCTIONS
An employee in this position may be called upon to do any or all of the
following essential functions. These examples do not include all of the
functions which the employee may be expected to perform.
Independently develops and submits Study Institutional Review Board (IRB)
documents such as consent forms and protocols for initial submissions,
protocol amendments, and continuing reviews.
Independently maintains appropriate study documentation including regulatory
binders and enrollment logs.
Responsible for preparing, maintaining and updating regulatory binders for
review by internal or external monitoring/auditing groups; a ailable to
auditors and monitors to discuss regulatory issues at each visit; able to
explain internal regulatory processes and Standard Operating Procedures
(SOPs) as needed.
Submits Adverse Event Reports and Protocol Deviations according to
insitutional review board and sponsor-specific reporting requirements.
Assesses current departmental processes and SOPs; provides suggestions for
improvement.
Enters protocol specific data into required IRB and Children's Hospital
Colorado systems.
Assists research team members in assessing and optimizing departmental
workflows.
Assists in training/mentoring new staff, providing constructive feedback
to other team members as necessary.
Maintains understanding of the professional guidelines and code of ethics
related to clinical research conduct, and maintains ability to summarize and
clarify these for study teams.
Full-time