Study Start Up Associate I

ICON plc•Rochester, NY

5d•Hybrid

About The Position

We have an incredible opportunity for a Site Manager/Start Up Associate I to join ICON’s Medical Imaging & Cardiac Safety Solutions Site Management team. The Site Manager/Start Up Associate I is responsible for assigned project site start-up and qualification activities per study specific requirements. They will provide support to sites for the life of all assigned projects. The Site Manager/ Start Up Associate I may carry a mixed portfolio of Imaging and Cardiac studies of varying complexity. Location: Office Based Hybrid (average of 3 days per week) Rochester, NY Blue Bell, PA What you will be doing: Establishing and maintaining strong working relationships with site contacts and internal departments Serving as main point of contact for Imaging and/or Cardiac sites participating in Clinical Trials Providing site support via email and telephone Generating and documenting all site communications associated with the Site Qualification process from initial contact to First Participant Ready status Providing sites their necessary access credentials Maintaining an audit ready file documenting the qualification process for all sites Ensuring weekly status follow ups are completed on time and entered in the site database Entering and updating site information in the site database as needed throughout the study Maintaining study specific site qualification trackers for sponsors Providing support and site updates on internal/external Kick Off meetings and weekly teleconferences Collaboration with Documentation & Training to ensure study requirements are in alignment and communicated with sites accordingly Request/track sites return equipment at study close Providing daily and weekly metrics for completed activities to management Creating unique project specific templates for site communication Proactively communicating with Project Management if issues or concerns arise that may impact site qualification Managing special projects and programs assigned by the Manager, Site Operations

Requirements

1-2+ years of clinical research experience, with an administrative focus
Advanced Microsoft Office Suite skills, specifically with Outlook and Excel
Strong attention to detail and organizational skills
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment
Associates degree in business, life sciences, or a related field

Nice To Haves

DATABASICS experience preferred

Responsibilities

Establishing and maintaining strong working relationships with site contacts and internal departments
Serving as main point of contact for Imaging and/or Cardiac sites participating in Clinical Trials
Providing site support via email and telephone
Generating and documenting all site communications associated with the Site Qualification process from initial contact to First Participant Ready status
Providing sites their necessary access credentials
Maintaining an audit ready file documenting the qualification process for all sites
Ensuring weekly status follow ups are completed on time and entered in the site database
Entering and updating site information in the site database as needed throughout the study
Maintaining study specific site qualification trackers for sponsors
Providing support and site updates on internal/external Kick Off meetings and weekly teleconferences
Collaboration with Documentation & Training to ensure study requirements are in alignment and communicated with sites accordingly
Request/track sites return equipment at study close
Providing daily and weekly metrics for completed activities to management
Creating unique project specific templates for site communication
Proactively communicating with Project Management if issues or concerns arise that may impact site qualification
Managing special projects and programs assigned by the Manager, Site Operations