Part-time CRA (Clinical Research Associate) – MDS Finland19.6.2022
Do you want to be a part of the important work on medical devices and new innovations?
We at MDS Finland are really excited about our work and want you to join us!
We offer interesting and challenging assignments with our customers innovative medical devices.
We are looking for a part-time (50%) CRA to (possibility of full-time work later)
- Being part of our CRO team
- Monitor independently (on-site or remotely) as per planned and verify that source data are complete, accurate, and maintained properly. Demonstrates diligence in protecting the confidentiality of each study patient. CRA will verify subject eligibility and protocol compliance, including safety reporting and IMD handling. And verify that all study files are maintained and up to date
- Set up the trial sites, ensure that the trial site has the trial materials, including IMD. Design data collection forms (CRF´s), and act as primary contact to study site personnel. CRA will be the main line of communication between the Clinical Project Manager, Sponsor, and the site staff
- Provide guidance to site staff as necessary, driving query resolution to closure within agreed timelines, perform investigational product inventory, reconciliation and reviews storage and security. Routinely reviews in Investigator Site File (ISF) for accuracy, timeliness, and completeness. Reconciles contents of the ISF with the Trial Master File (TMF)
- Ensure that study site follows to ICH-GCP, ISO 14155 and Clinical Investigation plan and other relevant guidance and regulations
- Ensure all assigned sites and project-specific site team members are trained and compliant with applicable requirements
”We want to be proud of the quality of our service. Satisfied customers are very important to us.”
Welcome if you identify yourself here:
- Bachelor´s degree (health care, life science or another relevant field)
- At least 2 years’ experience in clinical trials as a CRA, study coordinator or study nurse
- Good knowledge and ability to follow of ICH-GCP, ISO 14155, Clinical Investigation Plan and another relevant guidance and regulations and understanding of study site management and monitoring
- Good organizational and project handling skills and ability to work independently
- The ability to perform site visits accuracy, effectively and according to high quality standards
- Strong customer focus and good social skills
- Willing to travel, Home based – hybrid/– home office
- Fluent in Finnish and good English
- Medical Device experience preferred but not mandatory
We are a small work community where everyone’s input is important. If you are interested, please submit an application.