Site Management Associate I

PSI CRO•Durham, NC

13d•Hybrid

About The Position

Hybrid role in Durham, NC Site Management Ensures exchange of information and documentation with sites and vendors Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies Ensures regulatory and ethics committee submissions and notifications Ensures proper administration of sites and vendors payments Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections Reviews and coordinates site-specific query resolution Reviews and coordinates site-specific EDC completion and provides the site Monitor with regular updates on the completion status Other Communication Exchanges information and documentation with other departments Supports the organization of internal team meetings including preparation of agendas and minutes Supports the organization of Investigator Meetings Maintains study-specific and corporate tracking systems Serves as the sites’ primary contact point Serves as the primary sites’ contact point for vendors, study supplies, and access management Ensures communication between the sites and off-site facilities Training Arranges and tracks initial and on-going project training for site teams in all vendor-related systems Provides training in courier management and study supplies ordering to the site team Document Management Checks the TMF on a site and a country level regularly and files pending documents Prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists Provides Monitors with ISF documents to be filed in the ISF prior to each monitoring visit Revises and checks translations status Safety Management Ensures proper safety information flow with the investigative sites. CTMS Management Updates CTMS with lacking project information Assists the Monitors in their prompt completion of all subject event and site event information in CTMS Assists the Monitors in their meeting deadlines for site visits, visit reports and visit letter dates information recording in CTMS Tracks the resolution status of site issues and action items in CTMS Vendor Management Ensures that pre-study testing (dummy scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed Tracks vendor-related supplies (lab kits, ECG electrodes, CDs for scans, etc.) on a site level Other departmental assignments, as necessary

Requirements

College or university degree or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities is considered sufficient.
Minimum 2 year experience within the clinical research industry, corporate or academic environment where administrative experience and technical skills have been gained.
Basic proficiency in MS Word.
Basic proficiency in MS Excel.
Basic proficiency in MS Outlook.
Basic proficiency in MS Power Point.
Knowledge (following proper training) of applicable software and project specific systems.
Basic typing skills in English (min. 40 words per minute)

Responsibilities

Ensures exchange of information and documentation with sites and vendors
Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies
Ensures regulatory and ethics committee submissions and notifications
Ensures proper administration of sites and vendors payments
Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections
Reviews and coordinates site-specific query resolution
Reviews and coordinates site-specific EDC completion and provides the site Monitor with regular updates on the completion status
Exchanges information and documentation with other departments
Supports the organization of internal team meetings including preparation of agendas and minutes
Supports the organization of Investigator Meetings
Maintains study-specific and corporate tracking systems
Serves as the sites’ primary contact point
Serves as the primary sites’ contact point for vendors, study supplies, and access management
Ensures communication between the sites and off-site facilities
Arranges and tracks initial and on-going project training for site teams in all vendor-related systems
Provides training in courier management and study supplies ordering to the site team
Checks the TMF on a site and a country level regularly and files pending documents
Prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists
Provides Monitors with ISF documents to be filed in the ISF prior to each monitoring visit
Revises and checks translations status
Ensures proper safety information flow with the investigative sites.
Updates CTMS with lacking project information
Assists the Monitors in their prompt completion of all subject event and site event information in CTMS
Assists the Monitors in their meeting deadlines for site visits, visit reports and visit letter dates information recording in CTMS
Tracks the resolution status of site issues and action items in CTMS
Ensures that pre-study testing (dummy scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed
Tracks vendor-related supplies (lab kits, ECG electrodes, CDs for scans, etc.) on a site level
Other departmental assignments, as necessary