Clinical Research Associate to Q-linea

Q-linea continues to grow and is now looking to recruit a Clinical Research Associate (CRA) to join the company. Q-linea develops and delivers innovative solutions for the diagnosis of infectious diseases, with a keen focus on improving sepsis treatment while reducing antibiotic resistance. The company’s leading product, ASTar®, is a fully automated instrument for antimicrobial susceptibility testing (AST), which produces a sensitivity profile from a positive blood culture in approximately six hours. This is 24 to 40 hours faster than current diagnostics.
As a CRA, you will have a key role in the Clinical study team and help bring about a new reality of faster phenotypic AST that allows healthcare providers to accurately diagnose and treat infectious diseases in the shortest possible time. In this role, you will have the opportunity to be part of a team working on exciting and complex clinical studies and contribute to the overall management of our clinical trials. We are looking for a CRA who is passionate about clinical trials and wants an exciting position at a company in the forefront of innovative infectious disease diagnostics.

Q-linea has its HQ in Uppsala Sweden and is listed on the Nasdaq Stockholm Mid Cap. The position is full-time and preferably based in Stockholm or Uppsala, Sweden. We welcome your application today!


Responsibilities
As a CRA, you will be part of the Clinical Study team inside the Clinical Value Department at Q-linea and report directly to Chief Medical Officer (CMO) at the company.
Duties and responsibilities include:
• Conduct and document feasibility assessments to ensure that study sites are suitable and qualified for the trial.
• Support the Clinical Study Leader with the preparation of financial contracts between Q-linea and investigational sites with support from Legal and ensure adherence to payment schedule.
• Prepare and collect required site regulatory documents during all phases of the trial.
• Manage biobank applications.
• Prepare and maintain the Trial Master File (TMF) and the Investigator Site File (ISF).
• Prepare Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions, when applicable.
• Monitor studies and manage source data verification (SDV).
• Prepare the monitoring plan and other relevant documentation pertaining to clinical monitoring activities.
• Organize and execute site initiation and training.
• Implement complete site management including monitoring visits to ensure compliance with protocol, GCP, global and local regulations, global and local processes.
• Identify problems at sites, resolve issues and escalate as appropriate.
• Complete preparation of visit monitoring reports as per relevant SOP.
• Ensure collection and archiving of study documentation per relevant SOP during all phases of the trial.
• Manage (Serious) Adverse Device Effect (S)ADE) reporting and follow up of (S)ADEs.
• Review data capture forms, generate queries and resolve against established data review guidelines.
• Communicate effectively with site personnel, including the Principal Investigator (PI), and company management to relay protocol/study deviations and ensure timely implementation of corrective actions.
• Support the Clinical Data Manager with data management activities as applicable.
• Implement site close-out activities and generate a site close-out report.
• Provide feedback on site performance for future trial site feasibility/selection.


Your profile
The suitable candidate has the following qualifications:

Education:
- BSc or higher (MSc, PhD) degree within Life Sciences
Experience:
- At least 3 years’ experience as Clinical Research Associate, working for a CRO and/or in a similar position within the industry
Language:
- Fluent in English, both written and oral
Competencies:
- Excellent knowledge of GCP, IVDR and ISO 20916 requirements
- Knowledge of laboratory certification processes and standards

The ideal candidate for this position is driven, well organized and has a strong ability to build effective relationships with colleagues and collaborators. Strong communication and time management skills as well as excellent problem-solving skills are required to be successful in this role. Furthermore, we believe that you have excellent attention to detail and ability to maintain detailed and accurate records
If you are ready to bring your skills and experience to this position, we are ready to offer you an exciting and dynamic work environment where you will make a key difference and help patients get better clinical outcomes!


About the organisation
Q-linea AB is a public-listed diagnostic company focused on developing and delivering solutions to enable healthcare providers to diagnose and treat infectious diseases in the shortest possible time. Our vision is to help save lives by, as an innovative pioneer, ensuring that antibiotics can be maintained as an effective treatment for future generations. The company was founded in 2008 around technology developed by researchers from the Rudbeck Laboratory at Uppsala University, together with Olink Bioscience AB and Uppsala University's holding company UUAB. Q-linea today consists of a 100+ interdisciplinary and highly motivated team that conducts its operations in modern and well adapted premises in Uppsala Science Park and in Fyrislund. You can find more information about Q-Linea at www.qlinea.com