Senior Clinical Research Associate
Job Details
Full Job Description
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.
•
Requires at least 4 years of on-site monitoring experience.
• 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
#J-18808-LjbffrSenior Clinical Research Associate
IQVIA Argentina
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