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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.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical studies while ensuring compliance with GCP and regulatory standards. Proficient in data quality control, site monitoring, and effective communication with clinical teams and stakeholders.
Highest-signal resume keywords
Clinical Research ManagementGCP ComplianceData Quality ControlSite MonitoringClinical Data Analysis
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
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 & Qualifications
Bachelor in Natural ScienceNursing DegreeFurther Education in Clinical Research
Industry Keywords
Clinical StudiesGCPPrincipal InvestigatorsStudy CoordinatorsClinical InvestigationEthics CommissionSOPs
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