Clinical Trial Coordinator – Regulatory

Role Overview

• Serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.
• Monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.
• Assist CRAs with preparation for site visits ( i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits).
• Perform Case Report Form review, query generation and resolution against established data review guidelines, under direct supervision on Fortrea or client data management systems, as assigned by management.
• Assist with the coordination of study visits and shipment of drug, ancillary supplies and laboratory kits/samples.
• Manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.
• Liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.
• Proactively work with sites and project teams to ensure maintenance activities (including Amendments, revised documents, etc.) are completed for assigned sites as applicable in region.
• Demonstrate an understanding of the purpose of CTMS, how to use it, and how to navigate within the different sections.
• To enter weekly details in CTMS or as per study requirement.
• Assist in submissions and notifications to Ethics Committees and Regulatory Authorities as applicable in region.
• Facilitate translation and back translation of all necessary documents as appropriate for local country requirements and as needed regionally.
• Attend , as needed, meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings.

Requirements

• At least one year of experience in a related field, ( e.g. medical, clinical, pharmaceutical, laboratory research, data analysis, data management or technical writing).
• 1-2 years of clinical research is required.
• Basic understanding of biology and biological processes
• Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP.
• Good organizational and time management skills
• Good communication skills, oral and written
• Exhibits general computer literacy
• Works efficiently and effectively in a matrix environment
• University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology).

Tech Stack

• Google Cloud Platform

Benefits

• General Office Environment