Senior Clinical Research Associate

🚀 Rede Optimus is hiring: Senior Clinical Research Associate (Sr. 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 Senior Clinical Research Associate (Sr. CRA) based in Germany to strengthen our international clinical team.

Your role

As a Senior CRA at Rede Optimus, you will take an independent and senior role in the conduct of international medical device clinical investigations, working closely with Project Managers, Sponsors and investigational sites throughout the complete study lifecycle.

Your responsibilities will include:

• Independently managing assigned investigational sites from site selection and start-up through monitoring and close-out;
• Conducting site qualification/evaluation visits, Site Initiation Visits (SIVs), interim monitoring visits and close-out visits;
• Evaluating the capability of potential investigational sites and investigators to successfully conduct clinical investigations;
• Training and providing ongoing guidance to investigators and site staff on study procedures, source documentation, eCRF completion and applicable requirements;
• Reviewing study progress, source documentation, data quality, protocol compliance, patient visit compliance and device accountability, where applicable;
• Conducting on-site and remote monitoring activities and ensuring timely follow-up of findings and action items;
• Following up on safety events, protocol deviations, data queries and other study-related issues;
• Identifying, documenting and escalating non-compliance, risks and significant study issues to the Project Manager and/or Sponsor;
• Preparing high-quality monitoring reports and follow-up correspondence;
• Supporting the development and quality review of study-specific documents, including protocols, informed consent forms, eCRFs, study manuals and other study documentation;
• Supporting regulatory and Ethics Committee submissions;
• Supporting and attending Investigator Meetings;
• Supporting audits and regulatory inspections;
• Supporting the preparation, review and maintenance of the trial Master File (TMF) and Investigator Site Files (ISF);
• Taking a lead role within clinical trials when delegated, working closely with the Project Manager and Sponsor;
• Mentoring and supporting Junior CRAs and CRAs, as well as colleagues who are new to the company or study;
• Contributing your experience to continuously improve study execution, monitoring quality and internal clinical processes.
  

What we are looking for

⚠️ A minimum of 5 years of hands-on CRA experience is required for this Senior CRA position.

Candidates with less than 5 years of relevant CRA experience will not be considered for this vacancy.

In addition, you have:

• At least 5 years of hands-on experience as a CRA, preferably within a medical device company or CRO;
• Significant experience independently conducting monitoring visits and managing investigational sites;
• Experience across multiple clinical investigations and different phases of study execution;
• Experience with medical device clinical investigations is strongly preferred, particularly pre-market clinical investigations;
• A degree in medicine, pharmacy, biomedical sciences, biochemistry or another relevant life-science/natural-science discipline;
• Fluent German and English, both written and spoken;
• Strong working knowledge of ICH-GCP, ISO 14155 and EU MDR 2017/745 and other applicable clinical research requirements;
• The ability to independently identify risks, resolve site-level issues and escalate appropriately;
• Strong organizational and prioritization skills with the ability to manage multiple sites and responsibilities simultaneously;
• A proactive, pragmatic and solution-oriented approach;
• Strong communication skills and confidence interacting directly with investigators, Sponsor representatives and cross-functional study teams;
• Experience mentoring or supporting less experienced CRAs is an advantage;
• 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.
  

What we offer

At Rede Optimus, you will become part of a growing, international CRO with a strong specialization in medical device clinical research.

We offer:

• A competitive, market-based salary reflecting your seniority and experience;
• 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 senior position with a high level of independence, ownership and responsibility;
• A lean organizational structure with direct communication with Project Managers, management and Sponsor teams;
• The opportunity to mentor and support less experienced colleagues;
• Opportunities to further develop towards broader clinical trial leadership and project responsibilities;
• A collaborative and international working environment.
  

Interested?

If you are an experienced CRA with at least 5 years of hands-on CRA experience, are based in Germany and are looking for a senior role with greater independence and responsibility in medical device clinical research, 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.