Rede Optimus is hiring: Clinical Research Associate (CRA) – Germany
Location: Germany | Home-based or office-based | Regular European travel
Rede Optimus is a specialized medical device Clinical Research Organization (CRO) supporting innovative medical device companies in conducting clinical investigations across Europe and internationally.
As our activities continue to grow, we are looking for an experienced and motivated Clinical Research Associate (CRA) based in Germany to join our team.
Your role
As a CRA at Rede Optimus, you will be involved throughout the clinical investigation lifecycle, from study start-up and site initiation through monitoring, maintenance and study closure.
Your responsibilities will include:
- Supporting the development and review of study-specific documents throughout study start-up, conduct and close-out;
- Supporting regulatory and Ethics Committee submissions;
- Supporting site selection, qualification and activation activities;
- Assisting the Project Manager with site contract development, negotiation and execution;
- Training site staff on study procedures, source documentation and eCRF completion;
- Conducting on-site and remote monitoring activities independently, including initiation, interim monitoring and close-out activities;
- Reviewing study progress, source documentation, data quality and protocol compliance;
- Ensuring compliance with the protocol, applicable regulations, ICH-GCP and ISO 14155;
- Following up on safety events, deviations, outstanding actions and data queries;
- Preparing high-quality monitoring visit reports and follow-up correspondence;
- Identifying and escalating non-compliance, risks and study issues to the Project Manager and/or Sponsor;
- Supporting audits and inspections, when required;
- Supporting the preparation and maintenance of the Trial Master File (TMF) and Investigator Site Files (ISF);
- Working closely with Project Managers, CTAs, Data Management and other members of our international clinical team.
What we are looking for
⚠️ A minimum of 2 years of hands-on experience as a CRA or Junior CRA is required for this position.
Candidates without at least **2 years of relevant CRA experience will not be considered for this vacancy.
In addition, you have:
- At least 2 years of CRA/Junior CRA experience, preferably within a medical device company or CRO;
- A degree in medicine, pharmacy, biomedical sciences, biochemistry or another relevant life-science/natural-science discipline;
- Fluent German and English, both written and spoken; additional languages are an asset
- Knowledge of ICH-GCP and ISO 14155; familiarity with the EU Medical Device Regulation (MDR) is a strong advantage;
- Experience with site monitoring and clinical trial documentation;
- Strong organizational skills and the ability to manage your responsibilities and deadlines independently;
- A proactive, accurate and solution-oriented working style;
- Strong communication skills and the confidence to work directly with investigational sites and Sponsor teams;
- Good knowledge of standard software applications such as Word, Excel, PowerPoint and Adobe;
- Willingness and flexibility to travel regularly within Germany and across Europe;
- Additional language skills are considered a valuable asset.
Medical device clinical trial experience is strongly preferred.
What we offer
At Rede Optimus, you will become part of a growing, international CRO specialized in medical device clinical research.
We offer:
- A competitive, market-based salary;
- A home-based or office-based working arrangement, depending on your preference and location;
- The opportunity to work on innovative medical device technologies and international clinical investigations;
- A lean organizational structure with direct communication and close collaboration across project teams;
- A high level of independence and responsibility;
- Opportunities to further develop your clinical and regulatory expertise within the medical device field;
- A collaborative and international working environment.
Interested?
If you have at least 2 years of CRA experience, are based in Germany and would like to work on innovative medical device clinical trials within an international CRO, we would be happy to hear from you.
Apply now via LinkedIn or send your CV to [email protected] and join the Rede Optimus team.