Sr CRA I/II - FSP - Germany

Thermo Fisher Scientific GmbH; Deutschland; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

IT-Systemhaus der Bundesagentur für Arbeit in Germany seeks a Senior Clinical Research Associate (Level I) to monitor investigator sites and manage trial documentation, ensuring regulatory compliance and data integrity across on-site and remote visits.

You will coordinate with the Clinical Team Manager, support site activation, and drive issue resolution in collaboration with the client and project team.

Qualifikationen

• Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent.
• Total experience: at least 3 years as a CRA.
• Cell therapy experience: at least 2 years of on-site, hands-on experience.

Aufgaben

• Monitors investigator sites using risk-based monitoring; conducts on-site and remote monitoring.
• Provides trial status updates to CTM and ensures CTMS data is current.
• Initiates site activations and ensures protocol adherence and regulatory compliance.
• Ensures essential documents are complete per ICH-GCP and regulations.
• Interacts with sites, client, and project team to resolve issues and share findings.

Kenntnisse

Monitoring expertise

ICH-GCP knowledge

Clinical trial skills

Documentation accuracy

Regulatory knowledge

Ausbildung

Bachelor's degree in life sciences

Registered Nursing certification

Jobbeschreibung

Sr CRA I/II - FSP - Germany

Beginn

Work Schedule: Standard (Mon-Fri)

Environmental Conditions: Office

Job Description

Join Us as a Senior Clinical Research Associate (Level I) – Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

What You’ll Do

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assesses investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.
• Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
• Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
• Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
• Responds to company, client and applicable regulatory requirements/audits/inspections.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
• Contributes to other project work and initiatives for process improvement, as required.

Education and Experience Requirements

• Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
• Total experience: at least 3 years as a CRA.
• Cell therapy experience: at least 2 years of on-site, hands‑on experience.
• Location: various locations.

Knowledge, Skills and Abilities

• Effective clinical monitoring skills.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
• Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents.
• Well-developed critical thinking skills, including but not limited to a critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
• Ability to manage Risk Based Monitoring concepts and processes.
• Effective oral and written communication skills, with the ability to communicate effectively with medical personnel.
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues.
• Effective interpersonal skills.
• Strong attention to detail.
• Effective organizational and time management skills.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• Ability to work in a team or independently as required.
• Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software.
• Good English language and grammar skills.
• Good presentation skills.