Part-Time CRA II – Clinical Monitor, 0.8 FTE
Thermo Fisher Scientific
part-time
Posted on:
Location Type: Remote
Location: Germany
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Tech Stack
About the role
- Performs and coordinates all aspects of clinical monitoring and site management.
- Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation.
- Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to protect subjects' rights, safety and data integrity.
- Ensures audit readiness.
- Develops collaborative relationships with investigative sites.
- Monitors investigator sites using a risk-based monitoring approach; applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site process failures and implement corrective/preventive actions to bring the site into compliance and reduce risks.
- Ensures data accuracy through SDR, SDV and CRF review as applicable during on-site and remote monitoring activities.
- Documents observations in reports and correspondence in a timely manner using approved business writing standards.
- Raises observed deficiencies and issues to clinical management promptly and follows all issues through to resolution.
- Performs monitoring tasks in accordance with the approved monitoring plan.
- Participates in the investigator payment process.
- Investigates and follows up on findings as applicable.
- Ensures trial close-out and retrieval of trial materials.
- Conducts on-site file reviews per project specifications.
Requirements
- Bachelor's degree in a life sciences-related field or equivalent, plus relevant formal academic or vocational qualifications.
- Prior experience providing the knowledge, skills and abilities required for this role (equivalent to 2+ years as a Clinical Research Monitor).
- Valid driver's license.
- Full right to work in Germany.
- Fluency in English and German at a minimum of C1 level (note: the interview will be conducted in German).
Benefits
- Flexible work arrangements
- Professional development opportunities
- Preference will be given to severely disabled applicants with equal qualifications. / Schwerbehinderte Bewerber werden bei gleicher Eignung bevorzugt behandelt.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical monitoringsite managementprotocol complianceregulatory complianceroot cause analysisdata accuracySDRSDVCRF reviewinvestigator payment process
Soft Skills
critical thinkingproblem-solvingcollaborative relationshipscommunicationtimely documentationaudit readinessissue resolutionattention to detailorganizational skillsrisk management
Certifications
Bachelor's degree in life sciencesrelevant formal academic or vocational qualifications