Clinical Research Specialist

Integrated Resources Inc. • New Haven, CT, United States • $200k - $250k / year • 1w ago

Integrated 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 Description

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.
Arrange and participate in the organization of study team meetings, taking minutes and distributing.
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.
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 safety and welfare of patients enrolled in clinical studies.
Manage sites to ensure compliance.
Ensure integrity of data reported.
Help in setting up the study centers, 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.