PSI CRO
Pharmaceuticals
SiteManagementAssociate
Neural analysis suggests this role is
optimal for mid candidates.
“Site Management Associate at PSI CRO. Skills: Site management, Vendor management, Document management, CTMS management. Ensure information exchange with sites. Ensure documentation exchange with sites”
Industry & Context.
Query resolution
What They're Looking For.
Must Have
College or university degree or equivalent, Minimum 2 year experience clinical research, Basic proficiency MS Word, Basic proficiency MS Excel, Basic proficiency MS Outlook, Basic proficiency MS Power Point, Knowledge of applicable software, Basic typing skills English 40 wpm
What You'll Do.
Ensure information exchange with sites
Ensure documentation exchange with sites
Ensure information exchange with vendors
Ensure documentation exchange with vendors
Ensure order of clinical supplies
Ensure receipt of clinical supplies
Ensure inventory storage of clinical supplies
Ensure distribution of clinical supplies
Ensure return of clinical supplies
Ensure recall of clinical supplies
Ensure reconciliation of clinical supplies
Ensure regulatory submissions
Ensure ethics committee submissions
Ensure ethics committee notifications
Ensure administration of site payments
Ensure administration of vendor payments
Coordinate preparation for site audits
Coordinate follow-up on site audits
Coordinate preparation for TMF audits
Coordinate follow-up on TMF audits
Coordinate preparation for systems audits
Coordinate follow-up on systems audits
Coordinate preparation for site inspections
Coordinate follow-up on site inspections
Coordinate preparation for TMF inspections
Coordinate follow-up on TMF inspections
Coordinate preparation for systems inspections
Coordinate follow-up on systems inspections
Review site-specific query resolution
Coordinate site-specific query resolution
Review site-specific EDC completion
Coordinate site-specific EDC completion
Provide Monitor updates on EDC completion
Exchange information with other departments
Exchange documentation with other departments
Support organization of internal team meetings
Prepare agendas for team meetings
Prepare minutes for team meetings
Support organization of Investigator Meetings
Maintain study-specific tracking systems
Maintain corporate tracking systems
Serve as sites’ primary contact point
Serve as primary sites’ contact point for vendors
Serve as primary sites’ contact point for study
Serve as primary sites’ contact point for access
Ensure communication between sites and facilities
Arrange project training for site teams
Track project training for site teams
Arrange vendor systems training for site teams
Track vendor systems training for site teams
Arrange courier management training for site teams
Track courier management training for site teams
Arrange study supplies ordering training for site teams
Track study supplies ordering training for site teams
File pending documents
Prepare Investigator Site Files
Distribute Investigator Site Files
Update Investigator Site Files
Prepare ISF checklists
Distribute ISF checklists
Update ISF checklists
Provide Monitors ISF documents
Revise translations status
Check translations status
Ensure safety information flow with sites
Update CTMS with project information
Assist Monitors with CTMS completion
Assist Monitors with site event information
Assist Monitors with subject event information
Assist Monitors with site visit deadlines
Assist Monitors with visit report deadlines
Assist Monitors with visit letter dates
Track resolution status of site issues
Track resolution status of action items
Ensure pre-study testing of facilities
Track vendor-related supplies on site level
How You'll Work.
Team & Collaboration
Exchange information departments; Exchange documentation departments; Internal team meetings; Investigator Meetings; Site teams training; Site teams communication; Sites and facilities communication
Communication Scope
Information exchange; Documentation exchange; Meeting preparation; Meeting minutes
Process & Methodology
Tracking systems maintenance
Full Job Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800+ driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. 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 an
Applying for this Site Management Associate role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on SmartRecruiters
- SmartRecruiters often includes a video screening step — check camera and mic permissions.
- Link your GitHub or portfolio directly in the profile section for technical roles.
- Applications may be reviewed by AI scoring before reaching a recruiter — use keywords from the job description.
ANONYMOUS · UNFILTERED
What do employees actually say about PSI CRO?
Real rants from real employees. Read before you apply.