- Ensuring effective coordination and support of different phases of a study project
- Operative support of clinical studies in accordance with the protocol, corresponding SOPs, current ICH-GCP guidelines and local law
- Preparation and creation of patient information and informed consents
- Submissions to national and international ethics committees and regulatory authorities
- Maintenance of required documentation archives of sites and sponsor
- Oversight of maintenance and distribution of study specific equipment
- Performing evaluation, initiation, monitoring and close-out visits
- Supporting the sponsor during documentation of adverse reactions and database maintenance
- Maintenance of study specific sponsor systems and their access permissions
- Planning, Organisation and conduct of investigator meetings and workshops
- Support in contractual matters and payments
- Support of sites and sponsor during audits and inspections
