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PSI CRO · 3 days ago

Site Management Associate I

King of Prussia, PA

Full-time

Hybrid

Entry Level

2+ years exp

PSI CRO is a dynamic global company focused on medical science and improving lives through new medicines. They are seeking a Site Management Associate I to ensure effective communication and documentation with sites and vendors, manage clinical supplies, and coordinate site audits and training.

Business Information SystemsHealth CarePharmaceutical

Culture & Values

No H1B

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

Qualification

Clinical research experienceMS WordMS ExcelMS OutlookMS PowerPointBasic typing skillsDocument managementVendor managementCommunication skills

Required

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)

Company

PSI CRO

Glassdoor4.1

PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.

Founded in 1995

Zug, Zug, CHE

1001-5000 employees