Senior Clinical Research Associate (CRA) I/II / Senior Klinischer Monitor (m/w/d)

Job Description

Thermo Fisher Scientific is seeking experienced Clinical Research Associates (CRAs) to join our team. This role offers meaningful work with a global impact, supporting our mission to make the world healthier, cleaner, and safer. Our clinical department provides end-to-end support for clinical trials, from study start-up to close-out, across commercial and government contracts.

This advert is for experienced CRAs with 2+ years of experience. We have positions available in multiple locations across Germany, including Berlin, Ulm, Karlsruhe, Frankfurt, Munich, and Hamburg. Roles can be fully home-based, fully office-based (Munich or Karlsruhe), or hybrid. We are open to full-time or 80% FTE, and all roles are permanent. Standard work hours are Monday to Friday, 40 hours per week.

The CRA Role:

• Performs and coordinates all aspects of the clinical monitoring and site management process.
• Conducts remote or on-site visits to assess protocol and regulatory compliance, managing required documentation.
• Acts as a site processes specialist, ensuring trials comply with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to safeguard subject rights, well-being, and data reliability.
• Ensures audit readiness.
• Develops collaborative relationships with investigational sites.
• Detailed tasks and responsibilities are outlined in the task matrix.
• Requires travel up to 50-75%.

A Day in the Life:

• Monitors investigator sites using a risk-based approach, applying root cause analysis (RCA), critical thinking, and problem-solving skills to identify and rectify site process failures and implement corrective/preventive actions.
• Ensures data accuracy through SDR, SDV, and CRF review via on-site and remote monitoring.
• Assesses investigational product through physical inventory and records review.
• Documents observations in reports and letters promptly, adhering to business writing standards.
• Expeditiously reports observed deficiencies and issues to clinical management, ensuring their resolution.
• Maintains regular contact with investigative sites between monitoring visits to confirm protocol adherence, issue resolution, and timely data recording.
• Conducts monitoring tasks according to the approved monitoring plan.
• Participates in the investigator payment process.
• Collaborates with project team members on issue/finding resolution.
• Investigates and follows up on findings as applicable.
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM).
• Ensures study systems (e.g., Clinical Trial Management System, CTMS) are updated per agreed conventions.
• Performs QC checks of CTMS reports as required.
• Participates in investigator meetings as necessary.
• Identifies potential investigators in collaboration with the client company, ensuring the acceptability of qualified sites. Initiates clinical trial sites per relevant procedures, ensuring compliance with protocol and regulatory/ICH GCP obligations, and makes recommendations. Ensures trial close-out and retrieval of trial materials.
• Verifies the completeness and accuracy of essential documents according to ICH-GCP and applicable regulations. Conducts on-site file reviews per project specifications.
• Contributes to the project team by assisting in the preparation of project publications/tools and sharing ideas/suggestions. Performs additional study tasks as assigned by the CTM.
• Facilitates effective communication between investigative sites, the client company, and the PPD project team through various channels.
• Responds to company, client, and regulatory requirements/audits/inspections.
• Maintains and completes administrative tasks such as expense reports and timesheets promptly.
• Contributes to other project work and initiatives for process improvement as required.

Education and Experience:

• Bachelor's degree in a life sciences related field or equivalent qualification.
• Minimum of 2 years of experience as a clinical research monitor or equivalent.
• Valid driver's license.
• Full right to work in Germany.
• Fluency in English and German (at least C1 level). The interview will be conducted in German.

Knowledge, Skills, and Abilities:

• Effective clinical monitoring skills.
• Demonstrated understanding of medical/therapeutic area knowledge and terminology.
• Excellent understanding and application of ICH GCPs, applicable regulations, and procedural documents.
• Well-developed critical thinking skills, including critical attitude, in-depth investigation for root cause analysis, and decision-making.
• Ability to handle Risk-Based Monitoring concepts and processes.
• Effective oral and written communication skills, with the ability to interact professionally with medical personnel.
• Customer focus, demonstrated through good listening skills, attention to detail, and the ability to perceive underlying customer issues.
• Effective social skills.
• Strong attention to detail.
• Effective organizational and time management skills.
• Flexibility and adaptability in various scenarios.
• Ability to work independently or as part of a team.
• Proficient computer skills (Microsoft Office and ability to learn new software).
• Good presentation skills.

Severely disabled applicants with the same aptitude will be given preferential treatment. / Schwerbehinderte Bewerber werden bei gleicher Eignung bevorzugt behandelt.

Work Locations:

• 22299 Hamburg
• 89073 Ulm, Donau
• 10115 Berlin
• 60313 Frankfurt am Main
• 80333 München
• 76131 Karlsruhe, Baden

Remote Model: Hybrid Country Code: DE