Site Management Associate I

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Site Management Associate I (SMA) - Office based in Swansea (with the option to work from home 2/5 times per week)

The Role:

• Acts as primary site contact/liaison for study and site management issues including addressing questions, inclusive of protocol

• Completes essential document collection and review throughout the study lifecycle.

• Organizes and maintains site clinical trial master file (TMF) documents.

• Works closely with Clinical Research Associates (CRAs) and Clinical Trial Managers (CTMs) to provide clinical trial support

• 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

• 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[1]specific processes, local regulatory requirements

What you need:

• College degree in medicine, science, or equivalent

• 1 + years experience working in clinical trials in a hospital or other setting
• Understanding GCP guidelines

• We welcome applications from Clinical Research/Study Coordinators or In-House CRAs
• Excellent written and verbal communication
• Ability to work to tight deadlines