Site Management Associate I
Site Management Associate I
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Job Description
Hybrid role in Research Triangle Park 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 followup on site TMF and systems audits and inspections
- Reviews and coordinates sitespecific query resolution
- Reviews and coordinates sitespecific 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 studyspecific 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 offsite facilities
Training
- Arranges and tracks initial and ongoing project training for site teams in all vendorrelated 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 prestudy testing (dummy scans MRI/CT qualification questionnaires test ECGs etc.) of local site facilities is completed
- Tracks vendorrelated 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.
Equivalency is defined as a minimum of 2 years experience in 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)
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
