Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description 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. Provide product training and support to clinical sites for the pill cam procedure. Support the randomization process and act as the IWRS PRIMARY Administrator. Arrange and participate in the organization of study team meetings, taking minutes and distributing them. Manage and maintain study documents and trial supplies, including colonoscopy forceps, FedEx envelopes, and IWRS user information. Administer, maintain, and coordinate the logistic aspects of clinical trials according to GCP and SOPs. Ensure that any clinical trial databases/tracking tools are set up and maintained throughout the trial. Assist with collating, tracking, and shipping CRFs and data queries to data management. Review and approve monitoring reports in Siebel. CTM SW update. Coordinate archiving of study documentation. Perform and support study site qualification, initiation, interim monitoring, and closeout visits according to SOPs, GCPs, FDA regulations, and ICH guidelines at multiple investigational sites. Ensure the safety and welfare of patients enrolled in clinical studies. Site management to ensure compliance. Ensure the integrity of data reported. Help in setting up the study centers, which includes ensuring each center has the trial materials and training site staff to trial-specific standards. Provide administrative support for CA and data management team including shipment, training records, and inventory control. Qualifications Bachelor’s degree in Engineering (B.A./B.S.C./Other). Experience required: 0-2 years. Additional Information Feel free to forward my email to your friends/colleagues who might be available. We do offer a referral bonus. Thank you for your time and consideration. I look forward to hearing from you! Warm Regards, Nisha Integrated Resources, Inc.
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