Clinical Trial Assistant
3 days ago
We are looking for our new Clinical Trial Assistant (Office Based with some flexibility) – Medical Devices
Your main responsibilities will include, but are not limited to:
The Clinical Trial Assistant (CTA) plays a key role within Qmed Consulting to administer, maintain and coordinate the logistical aspects of clinical trials, while ensuring compliance with ISO standards, Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs). The CTA also acts as a pivotal point of contact and support for the clinical trial team and as a trusted collaborator for the other CTAs.
The CTA will be involved in most activities for the preparation of conducting and completing a Clinical Trial. You will assist in setting-up and maintaining the Trial Master Files (TMF), the Investigator Site File (ISF), and/or other electronic filing systems. You will take part in the preparation essential clinical trial documentation, distribute, track and file documents. You will help ensure that clinical trial databases/tracking tools are set-up and maintained throughout the trial. You will be involved in preparing and maintaining and overseeing study documents, such as, Protocols, Investigator’s Brochures, functional plans, and case report forms. In collaboration with the CRAs and where relevant the CPMs, you will manage and maintain trial supplies e.g.; medical devices, patient Information sheets, patient diaries, lab kits and medical equipment for sites. You will help arrange and participate in the organisation of Investigator Meetings and Study Team Meetings, including the generation and distribution of minutes. You will assist with the Ethics / Regulatory Submissions and be instrumental in keeping track of submissions and approvals for a variety of the studies.
Other possible tasks may include assisting with CRF Design, database user testing, arranging translation of patient documents, and assisting Clinical Research Associates on monitoring visits. Further activities may cover assisting in the generation, review, and distribution of management reports from internal tracking systems at requested intervals.
What we look for in a candidate:
Successful candidates should want to excel in delivering administrative support to the organisation. You will also be expected to have a natural interest in driving improvement activities for relevant processes, workflows and IT tools in alignment with business goals.
You most likely have a university degree in health sciences, biology, pharmacy, nursing or similar, and an interest in wanting to work with planning and execution of clinical trials with medical devices.
- You have excellent prioritisation skills and good attention to detail.
- You have great communication skills, and you aim to reach deadlines, are proactive, flexible, and able to multi-task.
- You have solid IT skills and work in an organized manner with relevant systems and databases.
- It is essential that you can work independently, but also be an active contributor within the team.
- You have the ability and willingness to adjust quickly to new situations in a continuously developing environment.
- You would like to understand clinical trial processes and needs, including knowledge of ICH GCP and getting a deep insight into ISO 14155.
- Ideally you have a desire to work for a consulting firm.
About Qmed Consulting
Qmed Consulting A/S is a full-service medical device Contract Research Organisation (CRO), also providing strategic consulting services. We specialise within medical devices, in the following departments:
- Clinical Affairs
- Regulatory Affairs
- Quality Management
The driving force behind Qmed Consulting is our commitment to paving the way for new medical devices and new ideas to allow them entry to the market. We value an open, trust-based and creative working environment, great team spirit and a high-quality mind-set. Our working environment is characterised by interesting and demanding assignments. We offer a career in clinical trials, where you will be challenged every day in a friendly and exciting work environment.
This is an office-based position in Central Copenhagen. You will need to be proficient in both written and spoken English and Danish.
Sounds like you?
If you have any questions regarding the position, you are welcome to contact us at +45 56 64 1010 or
Start date is as soon as possible, but we will wait for the right candidate.
We look forward to hearing from you.
Seniority level- Entry level
- Full-time
- Research, Analyst, and Information Technology
- Industries
- Medical Equipment Manufacturing
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