Clinical Start-Up Specialist/Clinical Research Associate to A+Science
Are you looking to start your career as a Clinical Research Associate? A+ Science is now recruiting a dedicated and motivated Clinical Start-Up Specialist/Clinical Research Associate (CRA) to join the company.
A+ Science is a Swedish Contract Research Organisation (CRO). Since 1997 we have been performing clinical trials and supporting small, mid-size and big pharmaceutical, biotech, and medical device companies. We also offer broad expertise in pharmacovigilance (PV) services both during clinical trials and after marketing authorization. A+ Science is a dynamic company with driven, dedicated, and passionate individuals. We have been involved in hundreds of clinical studies, and we are very proud to be part of the clinical research which has made a difference in the lives of many patients. Our vision is to become the CRO best known for its unique and dedicated personnel with focus on customer satisfaction. To Earn Trust- Make Difference!
In this role you will be responsible for activities related to study start up and ongoing study document management and play a key role in our sponsor’s drug or device development process. You will collaborate with experienced and dedicated professionals within clinical services and work in an environment where you will make a difference. If this sounds interesting to you – come join us!
This is a full-time position and based in Stockholm. We will interview and evaluate candidates continuously so we welcome your application today!
About the position
As a Clinical Start-Up Specialist, you will be integral part of of our team and perform all study start up activities for clinical trials. You will report directly to the Head of Clinical Operations.
Key responsibilities include:
• Submission to the Authorities, Ethic Committee and Biobank
• Perform feasibilities and Pre study visits
• Internal project management
• Prepare financial/administrative agreements with study sites
• Study set up activities
• Site monitoring activities
• Site management including initial and continuous training (GCP, protocol and amendments) of site staff and monitoring of progress proactively
• Maintain profound knowledge in the study documents and procedures throughout the study.
• Participate in audits/inspections.
• Preparation and maintenance of study related files.
• Handling of reported AE, SAE and endpoint according to guidance documents and procedures.
• Budget and resource planning and follow up of the clinical study.
• Internal quality work and non-project work at A+ Science.
Key qualifications include:
– University degree, preferably within biochemistry/ biomedicine/ medicine or pharmaceutical/pharmacological science.
– Two to three years of work experience in the clinical research field e.g. as a CRA or experience in study set up / site initiation / study start up experience
– Understanding of the clinical research procedures, the drug development process and GCP/ICH guidelines.
– Computer proficiency.
– Good verbal and written communication and presentation skills in both Swedish and English.
– Organizational and problem-solving skills and an eye for details.
– Strong time management skills
– Ability to establish and maintain effective working relationships with coworkers and clients.