Clinical Research Specialist

Contractor will need to train onsite for 3 months and then be able to work remote.

·Provide product training and support to clinical sites for the pill cam procedure.

·Support the randomization process and act as the IWRS PRIMARY Administrator

·Arranging and participating in the organization of study team meetings Taking minutes and distributing

·Managing and maintaining study documents and trial supplies, colonoscopy forceps, FedEx envelop, IWRS User information.

·Administer, Maintain and coordinate the logistic aspects of clinical trials according to GCP and Sop’s

·Ensure That any clinical trial databases/tracking tools are set up and maintained throughout the trial

·Assist with collating, tracking & shipping CRFs & Data queries to data management

·Maintaining study data control table

·Review and approve monitoring reports in Siebel

·CTM SW update

·Coordinating archiving of study documentation

·Perform and support study site qualification, Initiation interim monitoring and closeout visits according to SOP’s GCP’s, FDA regulation and ICH guidelines at multiple investigational sites

·Ensure safety and welfare of Patient enrolled in clinical study

·Site management to ensure Compliance

·Ensure integrity of data reported

·Helping in setting up the Study centers, Which includes ensuring each center has the trial materials and training site staff to trial-specific standards

·Administrative support for CA and date management team including: shipment training records and inventory control.