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 Research Triangle Park, NC

Site Management

Ensures exchange of information and documentation with sites and vendorsEnsures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical suppliesEnsures regulatory and ethics committee submissions and notificationsEnsures proper administration of sites and vendors paymentsCoordinates preparation for and follow-up on site, TMF and systems´ audits and inspectionsReviews and coordinates site-specific query resolutionReviews 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 departmentsSupports the organization of internal team meetings including preparation of agendas and minutesSupports the organization of Investigator MeetingsMaintains study-specific and corporate tracking systemsServes as the sites’ primary contact pointServes as the primary sites’ contact point for vendors, study supplies, and access managementEnsures 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 systemsProvides 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 documentsPrepares, distributes, and updates Investigator Site Files (ISF) and ISF checklistsProvides Monitors with ISF documents to be filed in the ISF prior to each monitoring visitRevises and checks translations status

Safety Management

Ensures proper safety information flow with the investigative sites.

CTMS Management

Updates CTMS with lacking project informationAssists the Monitors in their prompt completion of all subject event and site event information in CTMSAssists the Monitors in their meeting deadlines for site visits, visit reports and visit letter dates information recording in CTMSTracks 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 completedTracks 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. 

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)

Additional Information

All your information will be kept confidential according to EEO guidelines.