Clinical Research Associate 2
IQVIA
full-time
Posted on:
Location Type: Office
Location: North Sydney • Australia
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Tech Stack
About the role
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution.
- Ensure copies/originals site documents are available for filing in the Trial Master File and verify that the Investigator's Site File is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management and monitoring visit findings.
- Collaborate and liaise with study team members for project execution support as appropriate.
Requirements
- Bachelor's Degree
- Requires at least 1 year 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.
Benefits
- Health insurance
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
on-site monitoringclinical research regulatory requirementsGood Clinical Practice (GCP)International Conference on Harmonization (ICH) guidelinesprotocol knowledgedata query generationCRF completionregulatory submissionsenrollment trackingstudy training administration
Soft Skills
written communicationverbal communicationorganizational skillsproblem-solving skillstime managementfinancial managementrelationship buildingcollaborationadaptabilityattention to detail
Certifications
Bachelor's Degree