Site Management Associate I/II

Department

Clinical & Regulatory Service

 

Location

Lexington, Kentucky/Berwyn, PA

 

Summary

Responsible for completing site management activities for assigned studies to ensure integrity of the data and study specifications and provides clinical and technical support to the project team.  Generally will be assigned to small, medium or large simple to medium complexity studies and may be assigned to one or more sponsors and one or more projects depending on business needs.

 

Requirements

Four (4) year or equivalent degree, preferably in a scientific discipline or health-related field.  RN, LPN or other healthcare professional with applicable work experience may be considered in lieu of degree.  Sound basic knowledge of medical and pharmaceutical terminology.

 

Responsibilities

 

  • Assist in managing clinical and regulatory aspects of assigned low complexity studies to ensure studies are completed on time, within budget and in compliance with SOPs, FDA or other local regulations and ICH/GCP guidelines.

  • Actively participate in planning, implementing and managing the start-up, execution and close-out activities of assigned studies.

  • Ensure the timely and appropriate collection, review and submission of essential documents as required.

  • Assist with the preparations and coordination of Investigator Meetings and attend and present at Investigator Meetings as required.

  • Assist with the development of study manual, monitoring conventions, telephone scripts, tracking forms and other study related documents.

  • Conducts and assists with administrative activities as a member of the project team.

  • Perform site management and in house study monitoring tasks for assigned sites.

  • With the sponsor and project manager, help to ensure optimal selection of Investigators and sites.

  • Act as the primary contact for site interactions and communications.

To contact Human Resources please click here. Or, feel free to contact us at:

REGISTRAT-MAPI

2343 Alexandria Drive, Suite 4000

Lexington, KY  40504.3276

Tel: 859.223.4334

Fax: 859.514.4350