IQVIA
Clinical Research Associate or SrCRA(m/w/x)
Full-timeWith HomeofficeExperienced
Basel
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PPPPD Switzerland GmbH
Senior Clinical Research Associate I, German, French, Italian speaking(m/w/x)
Allschwil
Full-timeRemoteSenior
Nejo AI Summary
Conducting remote/on-site visits for protocol compliance and risk-based monitoring in global clinical trials. 2+ years clinical monitoring experience required. Fully remote, standard work schedule, frequent site visits.
Requirements
- Bachelor's degree in life sciences or RN certification or equivalent qualification
- Experience comparable to 2+ years clinical research monitor
- Valid driver's license where applicable
- Equivalency of education, training, and experience considered
- Effective clinical monitoring skills
- Understanding of medical/therapeutic area knowledge and terminology (oncology preferred)
- Understanding and application of ICH GCPs, regulations, and procedural documents
- Critical thinking, root cause analysis, and problem-solving skills
- Ability to manage Risk Based Monitoring concepts and processes
- Effective oral and written communication skills with medical personnel
- Customer focus through listening, attention to detail, and issue perception
- Effective interpersonal skills
- Strong attention to detail
- Effective organizational and time management skills
- Flexibility and adaptability in various scenarios
- Ability to work in a team or independently
- Proficient computer skills: Microsoft Office and ability to learn software
- Fluent English, German, and French skills; Italian beneficial
- 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 protocols, ICH-GCP guidelines, and regulations
- Develop and maintain collaborative relationships with investigational sites
- Apply risk-based monitoring to identify and correct site process failures
- Ensure data accuracy through source data review and verification
- Conduct physical inventory and records review of investigational products
- Document observations in reports and letters using approved standards
- Escalate deficiencies and issues to clinical management and follow through to resolution
- Maintain regular contact with investigative sites between monitoring visits
- Conduct monitoring tasks according to the approved monitoring plan
- Participate in the investigator payment process
- Ensure shared responsibility with project team members on issue resolution
- Provide trial status updates and progress reports to the Clinical Team Manager
- Update study systems per agreed conventions
- Perform quality checks on reports generated from the CTMS system
- Participate in investigator meetings as needed
- Identify potential investigators in collaboration with the client company
- Initiate clinical trial sites to ensure compliance with protocols and regulations
- Ensure trial close-out and retrieval of trial materials
- Complete and maintain essential documents according to ICH-GCP and regulations
- Conduct on-site file reviews as per project specifications
- Assist in preparing project publications and tools
- Share ideas and suggestions with team members
- Perform additional study tasks as assigned by the Clinical Team Manager
- Facilitate communication between investigative sites, the client company, and the project team
- Respond to company, client, and regulatory requirements/audits/inspections
- Complete administrative tasks such as expense reports and timesheets
- Contribute to project work and process improvement initiatives
Work Experience
- 2 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Fluent
- German – Fluent
- French – Fluent
- Italian – Basic
Tools & Technologies
- Microsoft Office
Benefits
Flexible Working
- Fully Remote
Modern Office
- Office environment
Other Benefits
- Exposure to electrical office equipment
- Frequent site visits
- Frequent travel
- Extended overnight stays
- Exposure to infectious organisms
- Exposure to extreme temperatures
- Compliance with sponsor/client/site requirements
Job Security
- Exposure to biological fluids
- Personal protective equipment required
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of PPD Switzerland GmbH 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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PPPPD Switzerland GmbH
Senior Clinical Research Associate I, German, French, Italian speaking(m/w/x)
Allschwil
Full-timeRemoteSenior
Nejo AI Summary
Conducting remote/on-site visits for protocol compliance and risk-based monitoring in global clinical trials. 2+ years clinical monitoring experience required. Fully remote, standard work schedule, frequent site visits.
Requirements
- Bachelor's degree in life sciences or RN certification or equivalent qualification
- Experience comparable to 2+ years clinical research monitor
- Valid driver's license where applicable
- Equivalency of education, training, and experience considered
- Effective clinical monitoring skills
- Understanding of medical/therapeutic area knowledge and terminology (oncology preferred)
- Understanding and application of ICH GCPs, regulations, and procedural documents
- Critical thinking, root cause analysis, and problem-solving skills
- Ability to manage Risk Based Monitoring concepts and processes
- Effective oral and written communication skills with medical personnel
- Customer focus through listening, attention to detail, and issue perception
- Effective interpersonal skills
- Strong attention to detail
- Effective organizational and time management skills
- Flexibility and adaptability in various scenarios
- Ability to work in a team or independently
- Proficient computer skills: Microsoft Office and ability to learn software
- Fluent English, German, and French skills; Italian beneficial
- 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 protocols, ICH-GCP guidelines, and regulations
- Develop and maintain collaborative relationships with investigational sites
- Apply risk-based monitoring to identify and correct site process failures
- Ensure data accuracy through source data review and verification
- Conduct physical inventory and records review of investigational products
- Document observations in reports and letters using approved standards
- Escalate deficiencies and issues to clinical management and follow through to resolution
- Maintain regular contact with investigative sites between monitoring visits
- Conduct monitoring tasks according to the approved monitoring plan
- Participate in the investigator payment process
- Ensure shared responsibility with project team members on issue resolution
- Provide trial status updates and progress reports to the Clinical Team Manager
- Update study systems per agreed conventions
- Perform quality checks on reports generated from the CTMS system
- Participate in investigator meetings as needed
- Identify potential investigators in collaboration with the client company
- Initiate clinical trial sites to ensure compliance with protocols and regulations
- Ensure trial close-out and retrieval of trial materials
- Complete and maintain essential documents according to ICH-GCP and regulations
- Conduct on-site file reviews as per project specifications
- Assist in preparing project publications and tools
- Share ideas and suggestions with team members
- Perform additional study tasks as assigned by the Clinical Team Manager
- Facilitate communication between investigative sites, the client company, and the project team
- Respond to company, client, and regulatory requirements/audits/inspections
- Complete administrative tasks such as expense reports and timesheets
- Contribute to project work and process improvement initiatives
Work Experience
- 2 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Fluent
- German – Fluent
- French – Fluent
- Italian – Basic
Tools & Technologies
- Microsoft Office
Benefits
Flexible Working
- Fully Remote
Modern Office
- Office environment
Other Benefits
- Exposure to electrical office equipment
- Frequent site visits
- Frequent travel
- Extended overnight stays
- Exposure to infectious organisms
- Exposure to extreme temperatures
- Compliance with sponsor/client/site requirements
Job Security
- Exposure to biological fluids
- Personal protective equipment required
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of PPD Switzerland GmbH 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
PPD Switzerland GmbH
Industry
Pharmaceuticals
Description
The company enables customers to make the world healthier, cleaner and safer through clinical research and development.
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