Senior Clinical Research Associate for Clinical Trials Office

Do you want to play a key role in the development of future cancer treatments? We are currently seeking a Senior Clinical Research Associate who wants to work in a highly skilled research team and lead academic clinical trials at Karolinska University Hospital. We welcome your application! You will be offered: - A position working with clinical studies that make a real difference for patients - A competent, collaborative, and supportive team that shares knowledge and supports each other while driving improvement projects together - A balanced work environment with flexible hours, wellness benefits, and continuous professional development and training - An inspiring academic environment at one of Europe’s leading university hospitals - Access to Karolinska’s benefits and educational opportunities, including an introductory program and further training in GCP and clinical research. Of course, you will also benefit from the general advantages that Karolinska University Hospital offers you. About the position The Clinical Trials Office (CTO) is part of the Center for Clinical Cancer Studies, Theme Cancer at Karolinska University Hospital. We support researchers in the planning, execution, and follow-up of academic clinical trials and collaborate both nationally and internationally to drive the development of new treatments in the field of cancer. As a Senior CRA, you will be responsible for monitoring, quality control, and regulatory compliance in clinical studies. As a Senior Clinical Research Associate at the Clinical Trials Office (CTO), you will be a key person in Karolinska’s clinical cancer research. You will be part of an experienced team that conducts world-class academic clinical trials, where your work directly contributes to research that improves and prolongs lives. With us, you will work closely with researchers, investigators, and study teams in the execution of academic oncology and hematology studies – from start to finish – alongside a dedicated team of CRAs, CRMs, and data managers. In this role, you will: - Conduct initiation, monitoring, and closure visits according to ICH-GCP and internal procedures - Ensure patient safety, protocol adherence, and data integrity at participating trial sites - Monitor and document study progress, review source data, and manage queries and deviations - Provide support to investigators and study personnel regarding GCP, protocols, and study documentation - Ensure proper maintenance of Investigator Site Files (ISF) and contribute to the Trial Master File (TMF) - Participate in the development of internal processes, routines, and quality systems - Collaborate with national and international partners - Act as lead monitor in international studies and be responsible for monitoring agreements - Develop and revise monitoring plans for both national and international studies - Train new colleagues in monitoring as needed. The role also involves travel within Sweden to participating centers. We are looking for someone who: - Is meticulous, structured, and enjoys an independent role with significant personal responsibility - Has a natural sense of quality, patient safety, and good documentation practices - Thrives on building relationships and establishing trust with investigators and study personnel - Possesses strong communication skills and a positive, solution-oriented approach to work. Qualifications Requirements: - Higher education in a natural science field (e.g., biomedicine, pharmacy, medicine, or equivalent) - Experience in clinical monitoring (CRA) within drug trials - Deep understanding of ICH-GCP, EU regulations, and clinical research practices - Excellent proficiency in Swedish and English, both spoken and written Meritorious: - Experience from oncology or hematology studies - Experience with academic investigator-initiated studies - Familiarity with multicenter studies and international collaborations - Experience with electronic data capture systems (EDC) and risk-based monitoring. About the recruitment process Selection and interviews may take place continuously during the application period. As part of your application, you need to attach your CV. Instead of a cover letter, we ask you to answer selection questions and briefly explain why you are suitable for the role. Answering the questions is a prerequisite for your application to be considered complete. We warmly welcome your application - Together we are Karolinska! In connection with the appointment of positions involving the care of children and adolescents, the person offered the position will be checked against the suspicion and criminal records. https://www.karolinska.se/jobba-hos-oss/rekrytering-pa-karolinska/ As an employee at Karolinska University Hospital, you may be assigned to war service. https://www.karolinska.se/jobba-hos-oss/var-arbetsplats/totalforsvarsplikt-allman-tjansteplikt-och-krigsplaceringar-pa-karolinska-universitetssjukhuset/ If you are or have previously been employed by Region Stockholm, we will take internal references from your current or previous manager if you are considered for employment. For permanent positions, a probationary period may be applied. About Karolinska University Hospital At Karolinska University Hospital, we are proud to be one of the world’s leading