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 Durham, NC
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 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
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 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
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
Other departmental assignments, as necessary
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.