Senior Clinical Research Associate - FS

41 Premier Research Group Limited; Deutschland; On-site; EUR 60,000 - 90,000; Full time

Job summary

Premier Research is seeking a Senior Clinical Research Associate - FS to join our Functional Services Provider team in Germany. You will conduct on-site monitoring, ensure regulatory compliance, and collaborate with cross-functional teams across study sites.

Ideal candidates have 5–7 years of continuous monitoring experience, fluency in German and English, and familiarity with RAVE EDC or Veeva CTMS/TMF. Start mid Jan 2027 and end of year; oncology experience welcome.

Qualifications

• Bachelor’s degree in clinical, biological, scientific or health-related field or equivalent.
• 5–7 years of onsite monitoring and site management experience in clinical research.
• Fluent in German and English (written and spoken).
• Phase I experience preferred; oncology background acceptable.
• Experience with PK sample monitoring and safety assessments.

Responsibilities

• Conduct source verification against CRFs and source documents.
• Ensure proper training of site personnel and protocol compliance.
• Support regulatory inspections and reportable events processes.
• Maintain study visit reports and escalate issues as needed.
• Collaborate with cross-functional teams and study sites throughout all phases.
• Manage study contracts and site documentation via the applicable database.

Skills

German language

English language

Education

Bachelor's degree in clinical/biological/scientific/health-related field

Tools

RAVE EDC

Veeva CTMS/TMF

Job description

Premier Research is looking for a Senior Clinical Research Associate - FS to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

What you’ll be doing:

• Conducts source verification by comparing data recorded on Case Report Forms against source documents, verifying Informed Consent Forms for accuracy and completeness, and reviewing regulatory documents and device accountability records
• Maintains thorough documentation and proper escalation of issues related to visit reports.
• Ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with the protocol and applicable regulations.
• Supports regulatory inspection activities as required.
• Ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations.
• Participates in study-specific meetings, teleconferences and trainings.
• Collaborates with cross-functional team members and study sites throughout all study phases.
• Manages study contracts, requests/collects relevant investigator/site documentation (i.e. regulatory documents, financial disclosure forms, curriculum vitae/medical license), and reviews and approves documents in applicable database.

What we are looking for:

• Bachelor’s degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience
• Senior Clinical Research Associate with 5 to 7 years of practical experience conducting continuous independent onsite monitoring of clinical research sites as well as site management activities.
• Must be fluent in German & English written and spoken.
• Phase I, healthy human volunteers is preferred; however, we can look at candidates who have strong Oncology experience.
• Experience monitoring PK samples and process on-site, along with safety assessments recommended.
• RAVE EDC and Veeva CTMS/TMF very nice to have.
• To start mid Jan-2027 and end at the end of the year.

Premier Research is more than a company – it’s a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems. Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning. Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.