Senior Research Regulatory Affairs Associate
Company: Banner Health
Location: Sun City
Posted on: May 12, 2022
Primary City/State:Sun City, ArizonaDepartment Name:Clin
Ctr-Overhead-RsrchWork Shift:DayJob Category:ResearchHealth care is
constantly changing, and at Banner Health, we are at the front of
that change. We are leading health care to make the experience the
best it can be. We want to change the lives of those in our care -
and the people who choose to take on this challenge. If changing
health care for the better sounds like something you want to be
part of, we want to hear from you.The regulatory team is comprised
of regulatory associates/specialists who oversee Alzheimer's
Disease research, movement disorders research and clinical trials.
The Regulatory Affairs position works closely with coordinators,
clinicians, and clinical trial staff in an inclusive environment
with the goal of making lasting contributions to dementia and
movement disorder research. We are responsible for maintaining the
Investigator Site File for all studies electronically. We complete
submissions to IRBs and sponsors, update regulatory documents, and
respond to compliance questions. As a Regulatory Associate, you
will act as an integral person in the Banner Research and as part
of study teams helping to facilitate study regulatory processes.
You should have a strong sense of urgency and the ability to
prioritize your workload. Excels in a busy environment and capable
of multitasking while meeting deadlines on time. Are detail
orientated and extremely organized. Take ownership of work and
provides consistent results.This position is Monday through Friday,
8:00AM - 4:30PM, there is flexibility in start/end times. The
primary location for this position will be at the Banner Sun Health
Research Institute, on the Banner Boswell campus in Sun City. We
spend most of the day on the computer and interacting with staff,
monitors/sponsors and IRB.Your pay and benefits (Total Rewards) are
important components of your Journey at Banner Health. Banner
Health offers a variety of benefit plans to help you and your
family. We provide health and financial security options, so you
can focus on being the best at what you do and enjoying your
life.Banner Research is at the leading edge in a new era of
scientific discovery and innovation. Our basic and clinical
research faculty turns ground-breaking research findings into new
identification, treatment and prevention methods for diseases such
as Alzheimer's, Parkinson's, Cardiovascular disease, Cancer and
Orthopedics. We have an international reputation for our work and
we provide outstanding access for patients to clinical trials. Our
commitment to excellence allow us to make a difference in people's
lives every day.POSITION SUMMARYThis position is expected to
demonstrate some degree of personal and professional competency and
critical thought processes with guidance. Provides direction for
the daily operational coordination for all regulatory aspects of
sponsored, grant-funded and/or investigator-initiated research
projects. Serves as the professional resource for regulatory
information, handles the submission of electronic regulatory
documents; maintains electronic site documents. Leads coordination
of regulatory activities with sponsors, clinical research
organizations (CROs), clinical research staff, institutional review
boards (IRBs) and other internal stakeholders.
1. Prepare and submit research applications and perform regulatory
study start up activities, edit informed consents and other related
documents, may assist Principal Investigators (PIs) with protocol
and study-related document development, facilitate completion of
ongoing continuation reports to the IRB which include adverse event
and protocol deviation reporting, study amendment reporting and
complete other submissions to respective IRBs as required.
2.Maintain all electronic regulatory documents including protocols,
investigator brochures, consents, and recruiting materials.
facilitate completion of continuing reviews and amendments per
sponsor, participating institutions, Good Clinical Practice (GCP),
FDA and other applicable federal, state and local regulatory agency
regulations, policies and procedures, and/or guidelines.
3.Act as site's regulatory point-person to provide information to
the PI, Research Director or Clinical Trial Senior Manager, and
study staff regarding IRB submissions and approvals of
study-related documents. Maintain protocol status updates for
pending and active projects. May participate in departmental
meetings, conferences, and educational events.
4.Interact with sponsors and CROs, providing requested regulatory
documents throughout the life of a study. Participate in site
initiation visits, sponsor monitoring, audits and the FDA
inspections for review of electronic regulatory binders. Serve as
the liaison and expert regulatory representative and professional
resource for assigned projects. Interact with sponsors,
participating research institutions, CROs, regulatory agencies, and
involved institutional departments on behalf of the PI or the
5.Coordinate regulatory activities with the needs of research staff
or the IRB to ensure timely submission of all regulatory documents
and requests of sponsors.
6. Maintain up-to-date knowledge on federal, state, and local
research regulatory requirements. Serve as designated regulatory
point-person for audits performed by regulatory agencies (i.e.,
OHRP, ORI, and FDA). Engage in core measures of customer service.
Exhibit professional standards to ensure human subjects protection
in the conduct of clinical research.
7. Perform other administrative duties as required to support the
senior regulatory staff or the site's RD or CTSM.
Requires a bachelor's degree in business, healthcare administration
or science related field or at least two to three years of
substantial and ongoing professional experience working in the
research regulatory environment. In addition, an equivalent
combination of education and experience may be allowed.
Must have professional designations such as Certified Clinical
Research Professional (CCRP -), or Certified Clinical Research
Coordinator (CCRC -) or equivalent additional years of direct
research regulatory experience.
Must possess knowledge and understanding of the applicable
regulatory requirements, as well as the commonly accepted concepts,
practices and procedures within the research regulatory arena. In
addition, must be able to use them in varied situations. Ability to
plan, organize, set priorities, and work in a fast paced
environment and handle multiple projects. Demonstrated capacity to
problem solve, think critically and creatively, and provide
assistance through a consultative role. Interpersonal skills
necessary to establish and maintain effective working
relationships.Computer proficiency including, but not limited to:
operational knowledge of Microsoft Office computer applications
(such as MS Word, Outlook, Excel), ability to locate and synthesize
information on the internet, experience working with CTMS
Additional related education and/or experience preferred.
Keywords: Banner Health, Sun City , Senior Research Regulatory Affairs Associate, Other , Sun City, Arizona
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