CRA - France
Corin, France
Job Description
Clinical Research Associate (CRA) required to manage assigned clinical studies in compliance with protocols, company SOPs and applicable regulations on medical devices. The CRA is involved in all stages of the clinical study, including assisting with identifying and assessing investigational sites and investigators and setting up, initiating, monitoring and closing the study.
If you have previous Clinical Research experience, proven knowledge of clinical study designs and flexibility to travel 30% of the role to adapt to the needs of clinical studies, then apply now! Be part of a global orthopaedic manufacturer that develops breakthrough innovative devices to improve and extend people’s lives!
The key responsibilities for the Clinical Research Associate are to:
- Contribute to the development of clinical study protocols, case report forms (CRFs) and other study materials
- Assist in identifying and to assess the suitability of facilities to use as the clinical study site
- Assist in identifying/selecting an investigator who will be responsible for conducting the study at the local study site
- Liaise with investigators and site research teams to prepare the necessary documentation for the Ethics Committee (EC) and to manage any EC questions
- Coordinate the execution of study agreements
- Set up the study sites - ensuring each site has the study materials and conduct site initiation visit and site staff study-specific training
- Develop and maintain strong and effective relationships with all site personnel through regular communication throughout the study duration with key focus on driving study recruitment and compliance in accordance with the protocol
- Identify, evaluate, report and ensure adequate follow-up of adverse events per study protocol, company SOPs and applicable regulations
- Prepare and conduct on-site study monitoring visits throughout its duration verifying that data entered on to the CRFs is consistent with patient clinical notes
- Coordinate the collection of completed CRFs from study sites and participate in the review of departmental operating procedures.
- Write high quality and accurate visit reports and follow up with sites on outstanding items Perform the close-out activities on completion of the study
- Maintain and file study documentation in an organised manner and archive following study closure
- Prepare data for final analysis and contribute to final study summary report as requested
- Assist in the preparation and/or review of conference abstracts, manuscripts for the assigned studies
- Monitor the costs of the assigned studies to be in line with the agreed budget and escalate where differences are identified
- Contribute to development of regulatory documentation for Regulatory Authority applications/ approvals and or renewal
- Provide data summary and updates of the assigned studies for the internal Product Annual Post Market Surveillance (PMS) Meetings
Requirements
The ideal Clinical Research Associate will have / be:
- A degree level education in a life science subject or related field
- Previous clinical research experience within a healthcare company or Clinical Research Organisation (CRO). Experience in a medical device company is preferred.
- Understanding and knowledge of clinical study designs to study execution
- Advanced knowledge and experience with GCP/ICH, ISO 14155:2020 and medical device regulation (MDR) and local requirement.
- Basic statistical analysis and high attention to detail
- Good English speaking and written skills including writing clinical documents in English
- Confident communicator, both verbally and in writing, and in presenting information concisely to others in a group or one to one setting
- Effective interpersonal skills with ability to work in a team or independently as required
- Ability to multi-task and manage priorities with effective organisational and time management skills
- Demonstrated flexibility and adaptability
- Highly motivated with a proactive approach to learning and problem solving
- Ability to travel up to 30%, depending on the stage and needs of the clinical study.
Corin is a medical device business with innovative robotically assisted platforms for joint replacement surgery. Corin offers a unique combination of clinically proven hip amp; knee solutions and world leading technologies, our OMNIBotics amp; OPS systems utilize intelligent instrumentation to give surgeons the ability to perform patient-specific procedures with high accuracy, with more consistent results and improved recovery rates.
Corin provides equal employment opportunities to all employees a