Clinical Study Coordinator
Company: CVS Pharmacy
Location: Raleigh
Posted on: May 28, 2023
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Job Description:
Job DescriptionAs a Clinical Research Study Coordinator within
CVS Clinical Trial Services (CTS) you are a vital part of our
team's success. In your role you manage study sites at the regional
level including daily operations, healthcare provider support,
building and maintaining stakeholder relationships, and maintenance
of study documents and internal documents.What you'll do: Manage
clinical trial operations regionally including communications with
the academic medical centers, Institutional review boards, vendors,
and Sponsors. Support healthcare providers, ensuring study protocol
adherence, study related activities align with company policies and
operate within ICH and GCP guidelines. Ensure site compliance with
research protocols by reviewing all regulatory requirements to
confirm implementation of appropriate methods, practices, and
procedures for all research activities. Develops accurate source
materials, including study specific checklists and ensures
compliance from site staff. Create and maintain study documents
requested by sponsor, CRO, study manager or CVS Health Leaders.
Train trial delivery staff on protocol specific requirements,
terminology, and procedures. Manage and prepare study
materials/equipment, documentation, storage, and disposal/return.
Ensure essential documents (IB, protocol, ICFs and CRFs) are
current and maintained. Coordinate internal and external study
events/meetings including SQV, SIV, IMV and trainings, audits and
inspections. Draft and submit IRB submissions which include initial
submission, annual review, study closeout SAE reporting and
protocol deviations.Pay RangeThe typical pay range for this role
is:Minimum: 43,700Maximum: 97,400Please keep in mind that this
range represents the pay range for all positions in the job grade
within which this position falls. The actual salary offer will take
into account a wide range of factors, including location.Required
Qualifications 3+ years of experience coordinating multi center or
multiple clinical trials and managing regulatory or relevant
work/educational experience 3 years of experience with Good
Clinical Practice (GCP) and ICH guidelines Ability to work both
virtually and on-site Ability to travel up to 25% of the timeCOVID
RequirementsCOVID-19 Vaccination RequirementCVS Health requires
certain colleagues to be fully vaccinated against COVID-19
(including any booster shots if required), where allowable under
the law, unless they are approved for a reasonable accommodation
based on disability, medical condition, religious belief, or other
legally recognized reasons that prevents them from being
vaccinated. You are required to have received at least one COVID-19
shot prior to your first day of employment and to provide proof of
your vaccination status or apply for a reasonable accommodation
within the first 10 days of your employment. Please note that in
some states and roles, you may be required to provide proof of full
vaccination or an approved reasonable accommodation before you can
begin to actively work.Preferred Qualifications Comprehensive
knowledge of GCP and ICH guidelines ACRP or SOCRA Certification
Experience with preparing for and successfully managing regulatory
and sponsor inspections. Experience conducting clinical research in
multiple therapeutic areas. Experience coordinating study
activities for multi-center studies Experience with
EpicEducationHigh school diploma or GED equivalentBusiness
OverviewBring your heart to CVS Health Every one of us at CVS
Health shares a single, clear purpose: Bringing our heart to every
moment of your health. This purpose guides our commitment to
deliver enhanced human-centric health care for a rapidly changing
world. Anchored in our brand - with heart at its center - our
purpose sends a personal message that how we deliver our services
is just as important as what we deliver. Our Heart At Work
Behaviors support this purpose. We want everyone who works at CVS
Health to feel empowered by the role they play in transforming our
culture and accelerating our ability to innovate and deliver
solutions to make health care more personal, convenient and
affordable. We strive to promote and sustain a culture of
diversity, inclusion and belonging every day. CVS Health is an
affirmative action employer, and is an equal opportunity employer,
as are the physician-owned businesses for which CVS Health provides
management services. We do not discriminate in recruiting, hiring,
promotion, or any other personnel action based on race, ethnicity,
color, national origin, sex/gender, sexual orientation, gender
identity or expression, religion, age, disability, protected
veteran status, or any other characteristic protected by applicable
federal, state, or local law. We proudly support and encourage
people with military experience (active, veterans, reservists and
National Guard) as well as military spouses to apply for CVS Health
job opportunities.
Keywords: CVS Pharmacy, Raleigh , Clinical Study Coordinator, Healthcare , Raleigh, North Carolina
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