IQVIA
CRA1
“CRA 1 at IQVIA. Skills: Site monitoring, Regulatory requirements, Data management. Perform monitoring and site management work. Ensure sites conduct study as required”
Industry & Context.
Organizational and problem-solving skills
What They're Looking For.
Must Have
Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i. e. , Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines), 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
Nice to Have
Bachelor's Degree in scientific discipline or health care preferred, 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, Good therapeutic and protocol knowledge as provided in company training
What You'll Do.
Perform monitoring and site management work
Ensure sites conduct study as required
Perform site monitoring visits
Work with sites to track recruitment plan
Administer protocol and study training
Establish communication with sites
Evaluate quality and integrity of site practices
Escalate quality issues
Manage study progress
Track regulatory submissions and approvals
Track recruitment and enrollment
Track CRF completion and submission
Track data query generation and resolution
Support start-up phase
Ensure site documents are available for filing
Verify Investigator's Site File maintenance
Create and maintain site management documentation
Submit regular visit reports
Generate follow-up letters
Collaborate with study team members
Support project execution
Support development of recruitment plan
Support site financial management
How You'll Work.
Team & Collaboration
Collaborate and liaise with study team members for project execution support as appropriate; Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Communication Scope
Written and verbal communication skills; Good command of English language
Process & Methodology
Manage the progress of assigned studies
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