Remote Clinical Research Specialist

Contractor role providing product training, support, and clinical trial coordination, primarily remote with onsite training, based in New Haven, CT.

Location: New Haven, CT

Responsibilities

• 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 envelope, 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 & Data queries to data management.
• Maintain study data control table.
• 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 safety and welfare of patients enrolled in the clinical study.
• Site management to ensure compliance.
• Ensure integrity of data reported.
• Help in setting up the study centers, including 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.

Requirements

• Bachelor’s degree in Engineering, B.A., B.S.C., or other relevant field.