Site Management Administrator

General Summary

Provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable

protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g. ICH-Good Clinical

Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as primary point of

contact for study sites.

Primary Responsibilities

• 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[1]specific processes, local regulatory requirements

Requirement:

- 1+ year of SMA/IHCRA/CRC/SC experience

- Understanding on GCP and clinical trials

- Good communication skills

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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