Clinical Research Specialist

Integrated Resources, Inc

New Haven, Connecticut

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JOB DETAILS

JOB TYPE

Full-time

SKILLS

Administrative Skills, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Case Report Form (CRF), Clinical Data, Clinical Research, Clinical Study Publications, Clinical Trial, Data Management, Data Quality, Document Archiving, Employee Retention, FDA Requirements, GCP (Good Clinical Practices), ICH Regulations, Inventory Reports, Maintain Compliance, Meeting Minutes, Product Support, Sales Training, Siebel, Software Administration, Staff Training, Standard Operating Procedures (SOP), Talent Management, Training/Teaching, Work From Home

LOCATION

New Haven, Connecticut

POSTED

1 day ago

Clinical Research SpecialistIntegrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.Job DescriptionContractor 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.QualificationsBachelor's degree Engineering/ (B.A./B.S.C./Other)Experience required:0-2 years

Clinical Research Specialist

Integrated Resources, Inc

New Haven, Connecticut

About the Company

Integrated Resources, Inc

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