Clinical Research Associate

We are looking for a homebased CRA to work embedded at a single sponsor. Our Sponsor is an international Pharma company engaged in the development of life saving drugs.
You will be responsible for:
All aspects of site management and monitoring activities for assigned studies with responsibility for the successful management of the site right through to close-out.
Ensuring patient safety and ethical/regulatory compliance by managing investigator sites, site activities and monitoring site data.
Make sure that the operational study execution is on track from site selection to site close out by developing effective relationships with investigator site staff to ensure that all aspects of study delivery and commitments are met
Training investigator site staff on regulatory guidelines and procedures and monitoring compliance
Proactively identify potential issues and develop corrective and/or preventive action plans to ensure compliance and quality of study related activities or data
As a key contributor to the Trial Master File and study documents at the country level, ensure essential documents are appropriate and filed in a timely manner in the investigator site file.
As a member of the audit and regulatory inspection team, be a key contributor in the preparation, conduct and follow up of Site Audits and Regulatory Inspections to ensure a successful outcome.
Act as a mentor for new or less experienced CRAS on process, study, technical or behavioral competencies.



To enable success in this position you will have:
Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential
Fluency in Swedish and English is essential
You will be educated to degree level, have equivalent experience or be a licensed healthcare professional.