Vaga de Sr CRA 1
1 vaga: | Publicada em 11/05
- A Combinar
Sobre a vaga
Job Overview
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 sponsor requirements.
Essential Functions
" Perform site monitoring visits (selection, initiation, monitoring and close-out
visits) in accordance with contracted scope of work and Good Clinical Practice.
" 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) 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.
Qualifications
" Bachelor's Degree Degree in scientific discipline or health care preferred. Req
" Requires at least 2 years of year of on-site monitoring experience. Req
" Equivalent combination of education, training and experience may be accepted in
lieu of degree. Req
" Good knowledge of, and skill in applying, applicable clinical research
regulatory requirements.
" i.e., Good Clinical Practice (GCP) and International Conference on Harmonization
(ICH) guidelines.
" Good therapeutic and protocol knowledge as provided in company training.
" 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 English
language.
" 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
https://jobs.iqvia.com