(Sr) Clinical Research Associate (CRA) positions (only for application purpose)
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 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) 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 1 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
(Sr) Clinical Research Associate (CRA) Positions (Only For Application Purpose)
IQVIA
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