Clinical Research Associate II

RBW Consulting; Germany (OH); On-site; USD 57,103 - 79,944; Full time

Job summary

RBW Consulting partners with a leading CRO in Germany to hire a Clinical Research Associate (CRA) for onsite site monitoring. The role offers progression within a supportive, collaborative environment and exposure to multi‑sponsor studies.

The successful candidate will manage trial sites, conduct PSV/SIV visits, ensure compliance with ICH-GCP and SOPs, and support start‑up activities. Fluency in German and English and strong organizational skills are required.

Qualifications

• Experience in clinical research with independent monitoring in Germany.
• Strong knowledge of ICH‑GCP and regulatory requirements.
• Fluent in German and English (written and spoken).
• Excellent organizational and communication skills.

Responsibilities

• Manage assigned clinical trial sites and act as the primary site contact.
• Conduct site monitoring visits (PSV, SIV, routine monitoring, and close‑out visits).
• Ensure studies are conducted in compliance with protocols, ICH‑GCP, regulatory requirements, and SOPs.
• Support site start‑up activities, including feasibility and site selection.
• Review and maintain essential regulatory documentation.
• Monitor patient enrolment, site performance, and investigational product accountability.
• Provide regular site updates to the project team and contribute to study success.

Skills

Independent monitoring

German & English

Job description

We are partnering with a leading clinical research organisation to support their search for an experienced Clinical Research Associate (CRA) based in Germany. Our client is a mid‑sized CRO that’s outperforming the market this year through repeat business, multi‑sponsor studies, and a reputation for quality delivery. Working in onsite monitoring, they are offering real progression opportunity in a business that gives back to its team.

It’s a great balance - the scale and stability of a high‑performing CRO, but the autonomy and close‑knit feel of a mid‑sized business.

Key Responsibilities:

• Manage assigned clinical trial sites and act as the primary site contact.
• Conduct site monitoring visits (PSV, SIV, routine monitoring, and close‑out visits).
• Ensure studies are conducted in compliance with protocols, ICH‑GCP, regulatory requirements, and SOPs.
• Support site start‑up activities, including feasibility and site selection.
• Review and maintain essential regulatory documentation.
• Monitor patient enrolment, site performance, and investigational product accountability.
• Provide regular site updates to the project team and contribute to study success.

Requirements:

• Previous clinical research experience, including independent monitoring experience in Germany.
• Strong knowledge of ICH‑GCP and regulatory requirements.
• Fluent in German and English (written and spoken).
• Excellent organisational and communication skills.

What's on Offer:

• Opportunity to join a global and collaborative clinical research environment.
• Strong focus on professional development and career progression.
• Flexible working arrangements and a supportive team culture.
• The chance to contribute to innovative clinical research that improves patient outcomes.
• Incentive bonus schemes that pass the business success directly back to the team.