Clinical Research Associate (CRA)

IRW Consulting is seeking Clinical Research Associates (CRAs) on positions located in the Stockholm area.

You are welcomed to apply for the positions if you have Bachelor or Master?s degree in life sciences, pharmacy or nursing and preferably a minimum of 2 years of clinical research experience in Pharmaceutical industry and/or CRO company.

Qualifications and background:
Be accurate and have a high level of quality conscious.
Be well organized and adaptive to change.
Act responsible and be able to work independently.
Good knowledge of spoken and written English.
Good organizational skills.
Ability to work independently in a fast-paced environment.
Valid driving license.

Main Responsibilities:
Prepare and complete applications to the regulatory authorities and ethic committees.
Responsible for completion of study documentation such as CRFs, patient diaries, QoL forms etc.
Preparing Monitoring Manuals, Source Data Verification plans etc.
Perform routine site visits, including selection, initiation, interim and closure monitoring visits.
Manage assigned sites throughout the study by regular contacts to ensure site compliance, adequate enrolment, and understanding of study requirements.
Participate in Audits and Inspections and assist with company?s quality control initiative.
Assist in data validation and clean file procedures
Selecting and negotiating contracts with local/central laboratories, pharmacies etc.
Planning and participating at Investigators meeting
Responsible for final archiving of study documents in-house and on-site
Demonstrate willingness to take on any level project activity consistent with current or past experience in support of study delivery.