Overview
Site Management Associate Jobs in King of Prussia, Pennsylvania, USA at Psi CRO Ag
Position: Site Management Associate I
Job Description
Hybrid role in King of Prussia, PA
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 primary contact point for sites, vendors, study supplies, and access management.
Ensures communication between the sites and off-site facilities.
Training
Arranges and tracks initial and ongoing 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 regularly at the site and country level, filing pending documents.
Prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists.
Provides Monitors with ISF documents to be filed prior to each monitoring visit.
Revises and checks translation statuses.
Safety Management
Ensures proper safety information flow with investigative sites.
CTMS Management
Updates CTMS with project information.
Assists Monitors in completing subject and site event information promptly in CTMS.
Helps meet deadlines for site visits, reports, and related documentation in CTMS.
Tracks the resolution of site issues and action items in CTMS.
Ensures completion of pre-study testing (e.g., dummy scans, MRI/CT questionnaires, test ECGs).
Tracks vendor supplies (lab kits, ECG electrodes, scan CDs, etc.) at the site level.
Additional Information
All information will be kept confidential according to EEO guidelines.
Qualifications
College or university degree or equivalent education, training, and experience demonstrating the required knowledge, skills, and abilities.
Minimum 2 years of experience in the clinical research industry, either in a corporate or academic environment, with administrative and technical skills.
Proficiency in MS Word, Excel, Outlook, and PowerPoint.
Knowledge (after proper training) of applicable software and project systems.
Basic typing skills in English (minimum 40 words per minute).
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Title: Site Management Associate
Company: Psi CRO Ag
Location: King of Prussia, Pennsylvania, USA
Category: Administrative/Clerical (Data Entry), Healthcare
