Clinical Research Associate (CRA) / Site Manager – Europe (UK-based)
Location: Europe (UK-based with high travel to sites in Spain, Italy, Germany, France, Netherlands)
Contract Type: Flexible – EOR options available
Travel Requirement: High (to 5-6 sites across Europe)
Overview
We are seeking an experienced Clinical Research Associate (CRA) or Site Manager to manage and support the execution of clinical trials across multiple sites in Europe, including the UK, Spain, Italy, Germany, France, and Netherlands. The role will involve high travel, site management, data collection, and protocol setup across a variety of surgical settings, with a strong focus on data management and clinical operations. This is an excellent opportunity for someone with a background in clinical research, operating room (OR) settings, and medical technology with flexibility to take on a dynamic role in a fast-paced, growing environment.
Key Responsibilities
* Site Management & Monitoring:
* Oversee the execution and monitoring of clinical trials at 5-6 sites across Europe, including Spain, Italy, Germany, France, UK, and Netherlands.
* Ensure trial compliance with GCP, regulatory guidelines, and clinical protocols.
* Manage site startup activities, monitor progress, and perform regular site visits to ensure high-quality data collection and patient safety.
* Conduct regular site training and follow-up visits to ensure adherence to study protocols.
* Data Management:
* Oversee and ensure accurate data entry into relevant databases, including data verification and video management from sites.
* Assist with the setup of clinical protocols, ensuring that all necessary materials and databases are correctly implemented and maintained.
* Monitor data quality, resolve data discrepancies, and work with the data management team to ensure that clinical trial data is accurate, complete, and compliant.
* Prepare and assist with data demo sessions as needed.
* Clinical Research & Medical Tech Experience:
* Demonstrate knowledge of medical technology, particularly in relation to OR settings, including laparoscopic and robotic surgery.
* Experience in clinical research, particularly within colorectal surgery, soft tissue, general surgery, and gynaecology.
* Familiarity with laparoscopes, minimally invasive surgery techniques, and robotic surgery is essential.
* No orthopaedic or catheter lab experience required.
* Regulatory Compliance & Support:
* Work closely with clinical teams to ensure regulatory compliance, patient safety, and trial integrity across all study sites.
* Support the preparation of required documentation, including protocol amendments and clinical trial reports.
* Ensure sites remain inspection-ready, with a proactive approach to quality control and audit preparation.
Skills & Experience
* Clinical Research Experience:
* Previous experience as a CRA, Site Manager, or similar role in clinical research and clinical trial management.
* Experience working with data management, including data entry, quality control, and study setup.
* Background in medical technology or clinical trials involving medical devices is a plus.
* Surgical & OR Experience:
* Hands-on experience or familiarity with operating room environments, specifically in laparoscopic surgery, robotic surgery, and other minimally invasive surgical techniques.
* Experience in colorectal surgery, soft tissue, general surgery, and gynaecology is highly desirable.
* Language & Communication Skills:
* English proficiency required, as communication with sites across Europe will be primarily in English.
* Knowledge of Japanese would be an asset but is not essential.
* Flexibility & Travel:
* The role requires high travel across European sites, so flexibility is key.
* Ability to manage workload independently and take ownership of trial progress with minimal supervision.
Additional Information
* This is not a super-fast process, but we are looking for someone with the right experience who can take on a high-visibility, highly flexible role.
* The role will primarily involve data management, with the opportunity to demonstrate clinical tech in surgical environments.
* Budget is available for the right candidate, but the timeline is not short, allowing for careful selection of the ideal candidate.
* We are looking for someone who can go about the work gently, without overwhelming the sites with too much at once.