Country: Australia (Office based; Sydney and Melbourne locations)

The Role:

• Assists in identifying study sites by performing site feasibility and recruitment tasks, e.g., completing, disseminating and reviewing responses to site recruitment questionnaires.

• Completes essential document collection and review throughout the study lifecycle inclusive of site activation. Organizes and maintains site clinical trial master file (TMF) documents.

• Sets up and maintains site-related data in applicable clinical systems according to procedures and guidelines.

• Acts as primary site contact/liaison for study and site management issues including addressing questions, inclusive of protocol questions, managing study supplies and conducting offsite central monitoring visits/contacts (pre-study, initiation, monitoring and close out visits). Escalates issues and risks as needed.

• Ensure timely and complete data entry by site. Perform data review inclusive of site level data review, query resolution, facilitate database closure and freezing procedures as per study plans.

• Performs risk assessment and management responsibilities throughout the project including site process evaluation, addressing follow up items and issue escalation.

• Performs all tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company and sponsor SOPs, project plan, study specific processes, local regulatory requirements.

• Performs a variety of routine essential document collection, review, negotiation, to ensure successful site activation and maintenance and close out tasks under general supervision.

• Performs recruitment of study sites, ensuring activities, documents and all other clinical data are accurately tracked and documented for the project lifecycle. Escalates issues as needed.

• Complete submissions and notifications to regulatory authorities, ethics committee and other bodies.

• May serve as a patient management associate (conduct patient interviews, answer questions, follow up on issues).

• Performs and documents clinical data review and query creation, query resolution, offsite central monitoring contacts/visits and site management communications as outlined in the study plans (and/or other processes)

• Sets up and maintains study documentation in applicable systems, e.g., clinical trial management system (CTMS), TMF system, applicable site/sponsor systems according to project protocol, applicable SOPs and project plans.

Requirements:
• University degree in Life Sciences, Biomed or equivalent
• You should also have knowledge of ICH-GCP guidelines and the expertise to review and evaluate medical data
• You will possess excellent written and verbal communication in English
• Good social skills enabling you to deal with queries in a timely manner

Apply here: https://careers.iconplc.com/job/site-management-administrator-in-australia-sydney-jid-35947