CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Case Report Form (CRF), Clinical Data, Clinical Research, Clinical Trial, Data Quality, FDA Requirements, GCP (Good Clinical Practices), ICH Regulations, Information Technology & Information Systems, Inventory Reports, Meeting Minutes, Product Support, Rehabilitation Nursing, Sales Training, Staff Training, Standard Operating Procedures (SOP), Training/Teaching
Remote Clinical Research SpecialistIntegrated 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 Description70% 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 remoteJob description:Provide product training and support to clinical sites for the pill cam procedure.Support the randomization process and act as the IWRS PRIMARY AdministratorArranging and participating in the organization of study team meetings Taking minutes and distributingManaging 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'sEnsure That any clinical trial databases/tracking tools are set up and maintained throughout the trialAssist with collating, tracking & shipping CRFs & Data queries to data managementMaintaining study data control tableReview and approve monitoring reports in SiebelCTM SW updateCoordinating archiving of study documentationPerform 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 sitesEnsure safety and welfare of Patient enrolled in clinical studySite management to ensure ComplianceEnsure integrity of data reportedHelping in setting up the Study centers, Which includes ensuring each center has the trial materials and training site staff to trial-specific standardsAdministrative support for CA and date management team including: shipment training records and inventory control.QualificationsBachelor's degree Engineering/ (B.A./B.S.C./Other)Experience required:0-2 yearsI
Integrated Resources, Inc