CRA I (Florida) - Remote
Company: ICON Strategic Solutions
Location: Olympia
Posted on: September 11, 2023
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Job Description:
The Clinical Research Associate may be regionally based and is
responsible for the monitoring of clinical trial activities in
compliance with FDA regulations, ICH/GCP guidelines and company
SOPs, to support New Drug Applications. The CRA will support
project teams in the placement, implementation, communication, site
management, recruitment and retention (R&R) issue
identification and resolution, and activities required at the
conclusion of clinical studies, as stipulated in the monitoring
plans for assigned projects. **What you will be doing:** **Study
Planning** Contribute to the identification of new sites for
clinical trials; analyse capability and support CRMA and CSM in
making recommendation for trial inclusion. Assume ambassadorial
role to facilitate communication between sites and Novartis CPO to
increase value proposition to investigators. Facilitate the
preparation and collection of site and country level documents
during all phases of the trial. Supports the CSM in the oversight
of Country and Site Trial Master Files (TMF). During all phases of
the trial ensure archiving per relevant SOP. Negotiate investigator
remuneration; prepare financial contracts between investigational
sites and investigators. Ensure adherence to payment schedule.
**Study Execution** Implement complete site management including
monitoring visits, regulatory assessment, drug supply management,
etc. to ensure compliance with protocol, GCP, global and local
regulations, global and local processes. Identify problems at
sites; resolve issues and escalate as appropriate. Collaborate with
the CSM to ensure recruitment and execute contingency plans, as
needed. Complete preparation and generation of visit monitoring
reports as per relevant SOP Review and manage data at site; resolve
technical and content issues on a continuous basis in order to
achieve timely database lock targets. If working with central CRAs
(blinded and un-blinded), respond to alerts and follow-up to ensure
resolution of issues **Study Close-out** Implement site close-out
activities and generate site close-out report. Provide feedback on
site performance for future trial site feasibility/selection
**General** Improve skills by timely completion performance of
assigned global and local training. **You are:** + Minimum 1 year
prior monitoring experience with global trials.In-depth knowledge
of FDA regulations and ICH/GCP guidelines + Excellent interpersonal
and communication skills (verbal & written), including proficiency
in medical terminology and computer systems + Ability to work
effectively with investigators and other research personnel,
maintaining a professional demeanor + Ability to independently
resolve site or study related issues + Self motivated; detail
oriented; team player; flexible + Ability to prioritize workload to
meet project timelines, while managing multiple protocols across
therapeutic areas + Excellent organizational and time management
skills + Function effectively with high degree of personal
accountability + CCRA or SoCRA certified **Why ICON?** Our focus is
to provide you with a comprehensive and competitive total reward
package that comprises, not only an excellent level of base pay,
but also a wide range of variable pay and recognition programs. In
addition, our best in class employee benefits, supportive policies
and wellbeing initiatives are tailored to support you and your
family at all stages of your career - both now, and into the
future. Our success depends on the knowledge, capabilities and
quality of our people. Thats why we are committed to developing our
employees in a continuous learning culture one where we challenge
you with engaging work and where every experience adds to your
professional development. ICON, including subsidiaries, is an equal
opportunity and inclusive employer and is committed to providing a
workplace free of discrimination and harassment. All qualified
applicants will receive equal consideration for employment without
regard to race, colour, religion, sex, sexual orientation, gender
identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a
reasonable accommodation for any part of the application process,
or in order to perform the essential functions of a position,
please let us know. Interested in the role, but unsure if you meet
all of the requirements? We would encourage you to apply regardless
theres every chance youre exactly what were looking for here at
ICON whether it is for this or other roles.
Keywords: ICON Strategic Solutions, Olympia , CRA I (Florida) - Remote, Other , Olympia, Washington
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