PSI CRO
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 lacking project information
Assists the monitors in their prompt completion of all subject event and site event information in CTMS
Assists the monitors in 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
Vendor Management
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
Qualifications 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)
Additional Information For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.
All your information will be kept confidential according to EEO guidelines.
#J-18808-Ljbffr
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 lacking project information
Assists the monitors in their prompt completion of all subject event and site event information in CTMS
Assists the monitors in 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
Vendor Management
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
Qualifications 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)
Additional Information For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.
All your information will be kept confidential according to EEO guidelines.
#J-18808-Ljbffr