Entry Level Clinical Research Associate (Nationwide)
Company: IQVIA Holdings Inc
Posted on: November 26, 2022
Perform 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
* Perform 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) guidelines.
* Work 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) verify that the
Investigator's Site File (ISF) is maintained in accordance with GCP
/ ICH 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.
* Bachelor's Degree Degree in scientific discipline or health care
* Equivalent combination of education, training and experience may
be accepted in lieu of degree.
* Some organizations require completion of CRA training program or
prior monitoring experience.
* Basic knowledge of, and skill in applying, applicable clinical
research regulatory requirements (i.e., Good Clinical Practice
(GCP) and International Conference on Harmonization (ICH)
* Good therapeutic and protocol knowledge as provided in company
* Computer skills including proficiency in use of Microsoft Word,
Excel and PowerPoint and use of a laptop computer and iPhone and
iPad (where applicable).
* Written and verbal communication skills including good command of
* Organizational and problem-solving skills.
* Effective time and financial management skills.
* Ability to establish and maintain effective working relationships
with coworkers, managers, and clients.
IQVIA is a leading global provider of advanced analytics,
technology solutions and clinical research services to the life
sciences industry. We believe in pushing the boundaries of human
science and data science to make the biggest impact possible - to
help our customers create a healthier world. Learn more at
We are committed to providing equal employment opportunities for
all, including veterans and candidates with disabilities.
As the COVID-19 virus continues to evolve, IQVIA's ability to
operate and provide certain services to customers and partners
necessitates IQVIA and its employees meet specific requirements
regarding vaccination status.
Keywords: IQVIA Holdings Inc, Durham , Entry Level Clinical Research Associate (Nationwide), Healthcare , Durham, North Carolina
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