Company Description

PSI is a leading Contract Research Organization with almost 28 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.  We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

Site Management

Under supervision, exchanges data, documents and other project relevant information between investigative sites, site vendors and the project teamUnder supervision, may assist with clinical supplies (including medication) order, receipt, inventory storage, distribution, return/recall and reconciliationUnder supervision, supports CA submissions and notificationsUnder supervision, assists with handling administrative financial tasks Under supervision, may assist with preparation and follow-up of site, TMF and systems´ audits and inspections

Other Communication

Under supervision, exchanges data, documents, and other information with the project team and other departmentsUnder supervision, provides assistance with organization of internal team meetingsUnder supervision, prepares draft minutes of internal team meetings Under supervision, assists with preparation, attendance and follow-up of Investigator’s Meetings, as applicableUnder supervision, maintains study-specific and corporate tracking systems

Document Management

Under supervision, maintains Trial Master File (TMF)Under supervision, may perform TMF review and oversight at country and site levelUnder supervision, prepares, distributes, and updates Onsite Study Files (OSF) and OSF checklistsUnder supervision, provides assistance with translations

Safety Management

Under supervision, may assist with safety information flow between investigative sites and the project teamCorporate/Departmental AssignmentsUnder supervision, may provide administrative assistance with feasibility research

Other Assistance

Provides miscellaneous administrative project support (if applicable)

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. 

Basic proficiency in MS WordBasic proficiency in MS ExcelBasic proficiency in MS OutlookBasic proficiency in MS Power PointBasic proficiency in Skype for BusinessKnowledge (following proper training) of applicable software and project specific systemsBasic typing skills in English (min. 40 words per minute)

Additional Information

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