70% of an average work week, so about 28 hours/week.
Preferably working from New Haven, CT.
Contractor will need to train onsite and then be able to work remote
Job description:
- 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鈥檚
- 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鈥檚 GCP鈥檚, 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.