|Key participant in the design, implementation and monitoring of clinical trials, preparation
of integrated medical reports, INDs, Investigational Device Exemptions (IDE), periodic
reports, PLAs, etc. Participates in design and writing of protocols, case report forms
and informed consent forms for clinical trials. Productive in recruitment/selection
of new investigators, contract research organizations and outside vendors. Responsible
for planning and implementing all activities required to conduct and monitor complex
clinical trials and ensure that Good Manufacturing Practices (GMP) are followed.
Conducts site visits pre-study, at study initiation, at regular intervals during the
study and at closeout. Monitors investigator performance and adherence to protocol.