-Ensures accurate, complete, timely and effective communication of study status and related issues are reported cross-functionally and to appropriate personnel at participating PKI sites
Required work experience related to position
Clinical study monitoring experience and/or knowledge of IVD products.
Knowledge of geographically-relevant regulatory requirements for IVD clinical studies, as appropriate
- Acts as the local clinical study coordinator for defined clinical studies
- Conducts study site qualification and monitoring visit: pre-study, study initiation, and at regular intervals during the study and at study closeout; and prepares reports of the visits.
- Oversees investigator performance and adherence to protocol, and proactively addresses conduct issues and problems, as necessary.
- Monitors that the training given by the PKI personnel and customers participating in the studies follow defined study procedures and protocols.
- Prepares and finalizes clinical study protocols, reports and other documents and obtains internal and external approvals. Provides documents and assists principal investigators with required EC submissions. Ensures receipt of EC approval prior to external study initiation.
- Forecasts resource needs and prepares and follows up the study costs and timelines