Sr. Clinical Research Associate
Reporting to: Office Manager/Clinical Research Manager
Desirable qualifications and background
- Academic degree in natural science such as life sciences
- Min. 2 years experience from pharmaceutical, biotechnology or medical device industries or
- Min. 2 years experience from Clinical Research Organizations (CRO)
- Good ability to express yourself both verbally and in writing
- Good knowledge of spoken and written English
- Good organizational skills
- A service-minded approach
- Ability to prioritize and handle several tasks simultaneously
- Valid driving license
- 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.
- Responsible for the sites and on-site management during the study process
- Drug accountability
- Participate in Audits and Inspections
- Assist in data validation and clean file procedures
- Prepare and conduct pre-study activities, selection and initiation visits, routine monitoring and closure visits
- 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