ICON plc
Sr. Clinical Research Associate(m/w/x)
Full-timeWith HomeofficeExperienced
Wien
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FRFR 503221 g PPD Austria, LTD
Clinical Research Associate (Level II) / Sr CRA(m/w/x)
Wien
Full-timeRemoteJunior
Nejo AI Summary
Remote and on-site clinical trial monitoring for a CRO, ensuring protocol compliance and subject safety. 1 year of clinical monitoring experience required. Site management and documentation focus.
Requirements
- Bachelor's degree in life sciences or RN certification/equivalent
- Experience comparable to 1 year as clinical research monitor or PPD Drug Development Fellowship
- Valid driver's license where applicable
- Equivalency of education, training, and/or experience considered
- Proven clinical monitoring skills
- Understanding of medical/therapeutic area knowledge and terminology
- Ability to attain knowledge of ICH GCPs and regulations
- Critical thinking, root cause analysis, and problem-solving skills
- Ability to manage Risk Based Monitoring concepts
- Good oral and written communication skills with medical personnel
- Customer focus, listening skills, attention to detail, problem perception
- Good organizational and time management skills
- Effective interpersonal skills
- Attention to detail
- Flexibility and adaptability in various scenarios
- Ability to work independently or in a team
- Good computer skills: Microsoft Office and ability to learn software
- Good English language and grammar skills
- Good presentation skills
Tasks
- Conduct remote or on-site visits to assess protocol and regulatory compliance
- Manage required documentation for clinical trials
- Ensure trial adherence to approved protocol, ICH-GCP guidelines, and applicable regulations
- Guarantee subjects' rights, well-being, and data reliability
- Ensure audit readiness and develop collaborative relationships with investigational sites
- Apply risk-based monitoring approach to identify and correct site process failures
- Conduct root cause analysis and problem-solving to bring sites into compliance
- Ensure data accuracy through source data review, source data verification, and CRF review
- Assess investigational product through physical inventory and records review
- Document observations in reports and letters using approved business writing standards
- Escalate observed deficiencies and issues to clinical management
- Follow issues through to resolution
- Maintain regular contact with investigative sites between monitoring visits
- Confirm protocol adherence and timely data recording
- Conduct monitoring tasks according to the approved monitoring plan
- Participate in the investigator payment process
- Share responsibility with project team members on issues and findings resolution
- Investigate and follow up on findings as needed
- Participate in investigator meetings
- Identify potential investigators in collaboration with the client company
- Initiate clinical trial sites to ensure compliance with protocol and regulatory obligations
- Perform trial close-out and retrieval of trial materials
- Ensure essential documents are complete and in place
- Conduct on-site file reviews as per project specifications
- Provide trial status tracking and progress updates to the Clinical Team Manager
- Update study systems per agreed study conventions
- Facilitate communication between investigative sites, the client company, and the PPD project team
- Respond to company, client, and regulatory requirements, audits, and inspections
- Complete administrative tasks such as expense reports and timesheets
- Contribute to project team by preparing project publications and tools
- Share ideas and suggestions with team members
- Contribute to process improvement initiatives
Work Experience
- 1 year
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Advanced
Tools & Technologies
- Microsoft Office
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of FR 503221 g PPD Austria, LTD and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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FRFR 503221 g PPD Austria, LTD
Clinical Research Associate (Level II) / Sr CRA(m/w/x)
Wien
Full-timeRemoteJunior
Nejo AI Summary
Remote and on-site clinical trial monitoring for a CRO, ensuring protocol compliance and subject safety. 1 year of clinical monitoring experience required. Site management and documentation focus.
Requirements
- Bachelor's degree in life sciences or RN certification/equivalent
- Experience comparable to 1 year as clinical research monitor or PPD Drug Development Fellowship
- Valid driver's license where applicable
- Equivalency of education, training, and/or experience considered
- Proven clinical monitoring skills
- Understanding of medical/therapeutic area knowledge and terminology
- Ability to attain knowledge of ICH GCPs and regulations
- Critical thinking, root cause analysis, and problem-solving skills
- Ability to manage Risk Based Monitoring concepts
- Good oral and written communication skills with medical personnel
- Customer focus, listening skills, attention to detail, problem perception
- Good organizational and time management skills
- Effective interpersonal skills
- Attention to detail
- Flexibility and adaptability in various scenarios
- Ability to work independently or in a team
- Good computer skills: Microsoft Office and ability to learn software
- Good English language and grammar skills
- Good presentation skills
Tasks
- Conduct remote or on-site visits to assess protocol and regulatory compliance
- Manage required documentation for clinical trials
- Ensure trial adherence to approved protocol, ICH-GCP guidelines, and applicable regulations
- Guarantee subjects' rights, well-being, and data reliability
- Ensure audit readiness and develop collaborative relationships with investigational sites
- Apply risk-based monitoring approach to identify and correct site process failures
- Conduct root cause analysis and problem-solving to bring sites into compliance
- Ensure data accuracy through source data review, source data verification, and CRF review
- Assess investigational product through physical inventory and records review
- Document observations in reports and letters using approved business writing standards
- Escalate observed deficiencies and issues to clinical management
- Follow issues through to resolution
- Maintain regular contact with investigative sites between monitoring visits
- Confirm protocol adherence and timely data recording
- Conduct monitoring tasks according to the approved monitoring plan
- Participate in the investigator payment process
- Share responsibility with project team members on issues and findings resolution
- Investigate and follow up on findings as needed
- Participate in investigator meetings
- Identify potential investigators in collaboration with the client company
- Initiate clinical trial sites to ensure compliance with protocol and regulatory obligations
- Perform trial close-out and retrieval of trial materials
- Ensure essential documents are complete and in place
- Conduct on-site file reviews as per project specifications
- Provide trial status tracking and progress updates to the Clinical Team Manager
- Update study systems per agreed study conventions
- Facilitate communication between investigative sites, the client company, and the PPD project team
- Respond to company, client, and regulatory requirements, audits, and inspections
- Complete administrative tasks such as expense reports and timesheets
- Contribute to project team by preparing project publications and tools
- Share ideas and suggestions with team members
- Contribute to process improvement initiatives
Work Experience
- 1 year
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Advanced
Tools & Technologies
- Microsoft Office
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of FR 503221 g PPD Austria, LTD and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
FR 503221 g PPD Austria, LTD
Industry
Healthcare
Description
PPD Austria, LTD is a Contract Research Organization specializing in clinical monitoring and site management for clinical trials.
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