PSI CRO
Company 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.
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 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 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 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 project information Assists Monitors in their prompt completion of all subject and site event information in CTMS Helps meet deadlines for site visits, reports, and visit dates in CTMS Tracks the resolution status of site issues and action items in CTMS Vendor Management
Ensures completion of pre-study testing of local site facilities Tracks vendor-related supplies at the site level Other departmental assignments, as necessary
Qualifications
College or university degree or equivalent experience demonstrating the required knowledge, skills, and abilities. Minimum 2 years of experience in the clinical research industry, corporate, or academic environment with administrative and technical skills. Proficiency in MS Word, Excel, Outlook, PowerPoint Knowledge of software and project systems (training provided) Basic typing skills in English (minimum 40 words per minute) Additional Information
All your information will be kept confidential according to EEO guidelines.
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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 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 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 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 project information Assists Monitors in their prompt completion of all subject and site event information in CTMS Helps meet deadlines for site visits, reports, and visit dates in CTMS Tracks the resolution status of site issues and action items in CTMS Vendor Management
Ensures completion of pre-study testing of local site facilities Tracks vendor-related supplies at the site level Other departmental assignments, as necessary
Qualifications
College or university degree or equivalent experience demonstrating the required knowledge, skills, and abilities. Minimum 2 years of experience in the clinical research industry, corporate, or academic environment with administrative and technical skills. Proficiency in MS Word, Excel, Outlook, PowerPoint Knowledge of software and project systems (training provided) Basic typing skills in English (minimum 40 words per minute) Additional Information
All your information will be kept confidential according to EEO guidelines.
#J-18808-Ljbffr