Part-Time CRA II – Clinical Monitor, 0.8 FTE

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🕒 February 10

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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.