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.

Bachelor’s degree Engineering/ (B.A./B.S.C./Other)

Experience required:

0-2 years

Kind Regards,

Sasha Sharma

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

DIRECT # - 732-662-7964