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Clinical Research Associate, 60-100%
AO FoundationClinical Research Associate managing clinical studies in collaboration with project leader. Ensuring adherence to study procedures and maintaining data quality for clinical trials.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Manage clinical studies under scientific and legal guidelines, in collaboration with the project leader
- Prepare, conduct and follow-up on site evaluation, site initiation, site monitoring, and site close-out of the involved clinics (on-site and remote)
- Assures adherence to GCP, investigator integrity and compliance with all study procedures through the monitoring phase
- Make short and long-term plans to monitor involved clinics to ensure data quality and compliance
- Prepare, develop, and submit documents for public authorities and/or ethics commission submissions
- Develop and adapt Case Report Forms (CRFs)
- Control quality and collection of clinical data
- Update Project Managers regarding the documentation quality of the clinics and report regularly on the general status of the participating site
- Prepare and implement solutions, in collaboration with the project leader or Head Clinical Operations, to maintain or adapt the project timelines, budget and scope
- Maintain contact with Principal Investigators and Study Coordinators and provide them support to conduct the clinical investigation
- Conduct regular trainings for study sites to ensure data quality and regulatory compliance within the clinical investigation
- Prepare and develop Study Newsletters and annual reports as requested by the Project Manager Clinical Operations
- Prepare clinical data for analysis in collaboration with the project team, including Project Coordinator, Data Manager and Medical Statistician
- Assist in optimizing quality standards and SOPs
- Prepare, assist and coordinate contract negotiations
Requirements
What you’ll need- Bachelor in Natural Science, nursing degree
- Further education in Clinical Research
- Work experience as a Clinical Research Associate
- Good market and product knowledge
- Basic medical knowledge
- Good understanding of study-related outcome measures
- Experience with data capture in the field of clinical research
- Strong organizational and follow-up skills
- Attention to detail and reliability
- Ability to work both independently and in a team
- Flexibility and customer-focused mindset
- Strong written and oral communication skills in English
Benefits
Comp & perks- An interesting and varied job in an exciting and innovative organization
- The opportunity to be part of a highly committed international team
- Modern infrastructure
- High degree of flexibility regarding working hours and location (depending on operational requirements)
- Generous package of social benefits, including supplementary vacation days and pension scheme contributions
- Internal skills training opportunities and support for continued education
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Clinical ResearchCase Report Form DevelopmentData CaptureSite EvaluationSite InitiationSite Close-OutRegulatory SubmissionsQuality Standards OptimizationContract NegotiationStudy-Related Outcome Measures
Soft Skills
Strong Organizational SkillsAttention to DetailReliabilityFlexibilityCustomer-Focused MindsetStrong Written CommunicationStrong Oral Communication
Certifications
Bachelor in Natural ScienceNursing DegreeFurther Education in Clinical Research