Clinical Operations comprises a group of about 25 qualified study coordinators and clinical monitors who are able to coordinate and monitor all aspects of a clinical trial.
Qualifications: Qualified medical documentalists, nurses, MScs, BScs.
Experience in clinical development: About 9 years on average with individuals who have up to 28 years of experience.
Organization, coordination, and conduct of clinical studies in accordance with regulatory requirements, ICH GCP, and client or Accovion SOPs.
In detail:
- Planning, preparation, and initiation of study-related activities
- Support for submission to regulatory authorities and ethics committees
- Supervision of study conduct and timelines
- Coordination of monitoring activities in participating countries
- Training and supervision of clinical monitors and other team members
- Supervision of transfer of pharmacovigilance-related data to corresponding team members
- Selection and coordination of external partners (e.g. central laboratory)
- Planning and organization of monitor, investigator, and study team meetings
- Preparation of presentations and presenting at such meetings
- Cooperation in development of study documents (e.g. protocol, informed consent)
- Organization and coordination of study material (e.g. medication, central laboratory)
- Maintenance of trial master file
- Cooperation in preparation of study reports
