Clinical Study Management

JANIX Clinical Study Management will work as the conduit between the Clinical Project Manager and the entire clinical operations team. The Clinical Study Manager will be responsible for all clinical research aspects, ethics submissions, drug oversight on shipments and reconciliation, reviewing monitoring reports, championing patient recruitment and retention initiatives, working with medical monitor with respects to collecting AE’s and SAEs, ongoing review of concomitant medications, and a variety of other clinical site related activities. 

All members of JANIX’ clinical study management team oversee and implement (internally and at a clinical site level) the clinical study process per current Good Clinical Practices (cGCP) to ensure the safety of the study subjects and maintain compliance to SOPs.

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