Job ID83190
LocationAurora, Colorado
Full/Part TimeFull-Time
Regular/TemporaryRegular
Why 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 Overview
The Director of Research Compliance is responsible for planning,
implementation, oversight and evaluation of the Children's Hospital
Colorado research compliance program to ensure all research activities are
compliant with internal research policies and applicable federal, state,
and local research regulations. You will play a pivotal role in overseeing
and managing our research and sponsored programs. You will have the
opportunity to work closely with faculty, research operations staff, and
other campus stakeholders in partnership with our Child Health Research
Enterprise and contribute to the overall success of our organization. You'll
leverage your expertise on pre-award and post-award administration of
externally funded grants and related research functions, with specific
emphasis on Uniform Guidance, Human Subjects Research, and Institutional
Review Board (IRB) compliance. You will be responsible for overseeing and
providing guidance to our health system's Conflict of Interest program,
including collaborating with the Multiple Institutional Review Board's
conflict of interest committee to review disclosures from investigators and
develop effective management plans. If you are passionate about promoting
ethical practices and ensuring regulatory compliance within the medical
research field, we invite you to apply for this exciting opportunity.
Qualifications
EDUCATION - Master's degree.
EXPERIENCE- Five (5) years of progressively responsible experience in
human subject protections, clinical research, grants and contracts
required. Plus, a minimum of three (3) years of
supervisory/leadership experience is required. Proficiency with federal,
state and local regulations related to clinical research protocols,
practices and human subject protection.
EQUIVALENCY- In lieu of a master's degree, a bachelor's degree with
(2) two additional years of professional experience in a supervisory role
in research compliance (or similar position applying complex regulatory
requirements in research) will serve as an equivalency.
CERTIFICATION(S) - Good Clinical Practice (GCP) and Human Subject
Protection certification awarded by the Collaborative Training Initiative
(CITI) required within 60 days of hire.
Responsibilities
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 functions
which the employee may be expected to perform.
Responsible for developing regulatory compliance through training,
education, strategic risk assessments, study auditing and monitoring in
collaboration within CHCO and its affiliates. Leads the organization-wide
research compliance program, working closely with various leaders and
partners, organizations, universities, medical centers,
institutions, and funding agencies.
Designs, develops, implements and oversees a portion of the annual
corporate compliance plan designed to ensure effective mitigation and
management of compliance risks. Completes a risk assessment for research
compliance.
Establishes and maintains a process to address, manage and resolve research
compliance issues, including allegations of research misconduct or
noncompliance with sponsor requirements, inquiries and complaints from
patients or families and reports to the Compliance Hotline.
Performs research compliance investigations and reviews. Coordinates the
investigation and response to any research compliance review or investigation