Clinical Trial Administrator - Durham, United States - PSI CRO

PSI CRO Durham, United States

4 weeks ago

Description

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 team
Under supervision, may assist with clinical supplies (including medication) order, receipt, inventory storage, distribution, return/recall and reconciliation
Under supervision, supports CA submissions and notifications
Under 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 departments
Under supervision, provides assistance with organization of internal team meetings
Under supervision, prepares draft minutes of internal team meetings
Under supervision, assists with preparation, attendance and follow-up of Investigator's Meetings, as applicable
Under 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 level
Under supervision, prepares, distributes, and updates Onsite Study Files (OSF) and OSF checklists
Under supervision, provides assistance with translations

Safety Management

Under supervision, may assist with safety information flow between investigative sites and the project team
Corporate/Departmental Assignments
Under 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 Word
Basic proficiency in MS Excel
Basic proficiency in MS Outlook
Basic proficiency in MS Power Point
Basic proficiency in Skype for Business
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.

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