Site Management Associate I

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          "text": "<p><strong><u>Hybrid role in King of Prussia, PA&#xa0;</u></strong></p><p>Site Management</p><ul><li>Ensures exchange of information and documentation with sites and vendors</li><li>Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies</li><li>Ensures regulatory and ethics committee submissions and notifications</li><li>Ensures proper administration of sites and vendors payments</li><li>Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections</li><li>Reviews and coordinates site-specific query resolution</li><li>Reviews and coordinates site-specific EDC completion and provides the site Monitor with regular updates on the completion status</li></ul><p>Other Communication</p><ul><li>Exchanges information and documentation with other departments</li><li>Supports the organization of internal team meetings including preparation of agendas and minutes</li><li>Supports the organization of Investigator Meetings</li><li>Maintains study-specific and corporate tracking systems</li><li>Serves as the sites’ primary contact point</li><li>Serves as the primary sites’ contact point for vendors, study supplies, and access management</li><li>Ensures communication between the sites and off-site facilities</li></ul><p>Training</p><ul><li>Arranges and tracks initial and on-going project training for site teams in all vendor-related systems</li><li>Provides training in courier management and study supplies ordering to the site team</li></ul><p>Document Management</p><ul><li>Checks the TMF on a site and a country level regularly and files pending documents</li><li>Prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists</li><li>Provides Monitors with ISF documents to be filed in the ISF prior to each monitoring visit</li><li>Revises and checks translations status</li></ul><p>Safety Management</p><ul><li>Ensures proper&#xa0;safety information flow with the investigative sites.</li></ul><p>CTMS Management</p><ul><li>Updates CTMS with lacking project information</li><li>Assists the Monitors in their prompt completion of all subject event and site event information in CTMS</li><li>Assists the Monitors in their meeting deadlines for site visits, visit reports and visit letter dates information recording in CTMS</li><li>Tracks the resolution status of site issues and action items in CTMS</li></ul><p>Vendor Management</p><ul><li>Ensures that pre-study testing (dummy scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed</li><li>Tracks vendor-related supplies (lab kits, ECG electrodes, CDs for scans, etc.) on a site level</li></ul><p>Other departmental assignments, as necessary</p>",
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          "text": "<p>College or university degree or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities is considered sufficient.&#xa0;</p><p>Minimum 2 year experience within the clinical research industry, corporate or academic environment where administrative experience and technical skills have been gained.</p><ul><li>Basic proficiency in MS Word.</li><li>Basic proficiency in MS Excel.</li><li>Basic proficiency in MS Outlook.</li><li>Basic proficiency in MS Power Point.</li><li>Knowledge (following proper training) of applicable software and project specific systems.</li><li>Basic typing skills in English (min. 40 words per minute)</li></ul>",
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          "text": "<p>We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.&#xa0;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.</p>",
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          "text": "<p>For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.</p><p>All your information will be kept confidential according to EEO guidelines.</p>",
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