CLINICAL RESEARCH ASSOCIATE 2, MEDICAL DEVICE - IQVIA MEDTECH
Company: IQVIA
Location: Durham
Posted on: September 26, 2024
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Job Description:
IQVIA MedTech is seeking a Clinical Research Associate II with
Medical Device monitoring experience! Central Nervous System (CNS)
experience is a plus!Job OverviewPerform monitoring and site
management work to ensure that sites are conducting the study(ies)
and reporting study data as required by the study protocol,
applicable regulations and guidelines, and sponsor
requirements.Essential FunctionsPerform site monitoring visits
(selection, initiation, monitoring and close-out visits) in
accordance with contracted scope of work and regulatory
requirements, i.e., Good Clinical Practice (GCP) and International
Conference on Harmonization (ICH) guidelinesWork with sites to
adapt, drive, and track subject recruitment plan in line with
project needs to enhance predictability.Administer protocol and
related study training to assigned sites and establish regular
lines of communication with sites to manage ongoing project
expectations and issues.Evaluate the quality and integrity of study
site practices related to the proper conduct of the protocol and
adherence to applicable regulations. Escalate quality issues as
appropriate.Manage the progress of assigned studies by tracking
regulatory submissions and approvals, recruitment and enrollment,
case report form (CRF) completion and submission, and data query
generation and resolution. May support start-up phase.Ensure
copies/originals (as required) site documents are available for
filing in the Trial Master File (TMF) and verify that the
Investigator's Site File (ISF) is maintained in accordance with GCP
and local regulatory requirements.Create and maintain appropriate
documentation regarding site management, monitoring visit findings
and action plans by submitting regular visit reports, generating
follow-up letters and other required study
documentation.Collaborate and liaise with study team members for
project execution support as appropriate.If applicable, may be
accountable for supporting development of project subject
recruitment plan on a per site basis.If applicable, may be
accountable for site financial management according to executed
clinical trial agreement and retrieve invoices according to local
requirement.QualificationsBachelor's Degree in scientific
discipline or health care preferredRequires at least 1 year of
on-site monitoring experienceGood knowledge of, and skill in
applying, applicable clinical research regulatory requirements
(i.e., Good Clinical Practice (GCP) and International Conference on
Harmonization (ICH) guidelines).Experience monitoring Medical
Device trialsIQVIA is a leading global provider of clinical
research services, commercial insights and healthcare intelligence
to the life sciences and healthcare industries. We create
intelligent connections to accelerate the development and
commercialization of innovative medical treatments to help improve
patient outcomes and population health worldwide. Learn more at
https://jobs.iqvia.comWe are committed to providing equal
employment opportunities for all, including veterans and candidates
with disabilities. https://jobs.iqvia.com/eoeIQVIA's ability to
operate and provide certain services to customers and partners
necessitates IQVIA and its employees meet specific requirements
regarding COVID-19 vaccination status.
https://jobs.iqvia.com/covid-19-vaccine-statusThe potential base
pay range for this role, when annualized, is $71,900.00 -
$189,000.00. The actual base pay offered may vary based on a number
of factors including job-related qualifications such as knowledge,
skills, education, and experience; location; and/or schedule (full
or part-time). Dependent on the position offered, incentive plans,
bonuses, and/or other forms of compensation may be offered, in
addition to a range of health and welfare and/or other
benefits.IQVIA is a world leader in using data, technology,
advanced analytics, and expertise to help customers drive
healthcare - and human health - forward. Together with the
companies we serve, we are enabling a more modern, more effective
and more efficient healthcare system, and creating breakthrough
solutions that transform business and patient outcomes.To get
there, it takes diverse skills and a curiosity to explore new
possibilities. No matter your role, everyone at IQVIA, including
our colleagues at Q - Solutions, contributes to our shared goal of
improving human health. Thank you for your interest in growing your
career with us.EEO Minorities/Females/Protected
Veterans/Disabled
Keywords: IQVIA, Durham , CLINICAL RESEARCH ASSOCIATE 2, MEDICAL DEVICE - IQVIA MEDTECH, Healthcare , Durham, North Carolina
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