Thermo Fisher Scientific
Assistant CRA - FSP(m/w/x)
Full-timeRemoteEntry Level
Karlsruhe
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HRHRA 11164 PPD Germany GmbH & Co KG
CRA I/II - Klinischer Monitor(m/w/x)
Karlsruhe, München
Full-timeRemoteExperienced
Nejo AI Summary
On-site and remote monitoring of clinical trials for life-changing therapies. Ensuring subject rights, well-being, and data reliability required. Home-based option, permanent full-time.
Requirements
- Bachelor's degree in life sciences or equivalent qualification
- Previous experience providing job knowledge, skills, and abilities
- Valid driver's license
- Full right to work in Germany
- English and German language fluency (C1 level)
- Effective clinical monitoring skills
- Understanding of medical/therapeutic area knowledge and terminology
- Understanding and application of ICH GCPs, regulations, and procedural documents
- Critical thinking skills for root cause analysis and decision-making
- Ability to handle 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
- 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 Microsoft Office skills and ability to learn software
- Good presentation skills
- Severely disabled applicants with same aptitude given preferential treatment
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 regulations
- Guarantee subjects' rights, well-being, and data reliability
- Maintain audit readiness
- Develop collaborative relationships with investigational sites
- Monitor investigator sites using risk-based monitoring approach
- Apply root cause analysis and problem-solving skills to identify and correct site issues
- 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 standards
- Report observed deficiencies and issues to clinical management
- Maintain regular contact with investigative sites between monitoring visits
- Conduct monitoring tasks according to the approved monitoring plan
- Participate in the investigator payment process
- Collaborate with project team members on issue resolution
- Investigate and follow up on findings
- Provide trial status and progress updates to the Clinical Team Manager
- Update study systems per agreed conventions
- Perform quality control checks on reports generated from CTMS
- Participate in investigator meetings
- Identify potential investigators in collaboration with the client company
- Initiate clinical trial sites according to relevant procedures
- Ensure trial close-out and retrieval of trial materials
- Complete required essential documents according to ICH-GCP and regulations
- Conduct on-site file reviews as per project specifications
- Assist in preparation of 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, client company, and PPD 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
- approx. 1 - 4 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Microsoft Office
Benefits
Flexible Working
- Home-based option
- Hybrid option
Other Benefits
- Office-based in Munich
- Office-based in Karlsruhe
Job Security
- Permanent full-time position
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of HRA 11164 PPD Germany GmbH & Co KG 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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HRHRA 11164 PPD Germany GmbH & Co KG
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Nejo AI Summary
On-site and remote monitoring of clinical trials for life-changing therapies. Ensuring subject rights, well-being, and data reliability required. Home-based option, permanent full-time.
Requirements
- Bachelor's degree in life sciences or equivalent qualification
- Previous experience providing job knowledge, skills, and abilities
- Valid driver's license
- Full right to work in Germany
- English and German language fluency (C1 level)
- Effective clinical monitoring skills
- Understanding of medical/therapeutic area knowledge and terminology
- Understanding and application of ICH GCPs, regulations, and procedural documents
- Critical thinking skills for root cause analysis and decision-making
- Ability to handle 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
- 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 Microsoft Office skills and ability to learn software
- Good presentation skills
- Severely disabled applicants with same aptitude given preferential treatment
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 regulations
- Guarantee subjects' rights, well-being, and data reliability
- Maintain audit readiness
- Develop collaborative relationships with investigational sites
- Monitor investigator sites using risk-based monitoring approach
- Apply root cause analysis and problem-solving skills to identify and correct site issues
- 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 standards
- Report observed deficiencies and issues to clinical management
- Maintain regular contact with investigative sites between monitoring visits
- Conduct monitoring tasks according to the approved monitoring plan
- Participate in the investigator payment process
- Collaborate with project team members on issue resolution
- Investigate and follow up on findings
- Provide trial status and progress updates to the Clinical Team Manager
- Update study systems per agreed conventions
- Perform quality control checks on reports generated from CTMS
- Participate in investigator meetings
- Identify potential investigators in collaboration with the client company
- Initiate clinical trial sites according to relevant procedures
- Ensure trial close-out and retrieval of trial materials
- Complete required essential documents according to ICH-GCP and regulations
- Conduct on-site file reviews as per project specifications
- Assist in preparation of 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, client company, and PPD 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
- approx. 1 - 4 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Microsoft Office
Benefits
Flexible Working
- Home-based option
- Hybrid option
Other Benefits
- Office-based in Munich
- Office-based in Karlsruhe
Job Security
- Permanent full-time position
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of HRA 11164 PPD Germany GmbH & Co KG 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
HRA 11164 PPD Germany GmbH & Co KG
Industry
Pharmaceuticals
Description
The company enables customers to make the world healthier, cleaner and safer through clinical research and development.
Not a perfect match?
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