Summary: Provides support to Study Manager and other study team members. Tracks and maintains study and investigator-related clinical trial documents, files, study supplies, and vendor information. Keeps study related documentation current and filed. May also be responsible for coordination of supplies to clinical sites, and contacting sites as directed. May facilitate collection and review of essential documents and IRB submissions on behalf of sponsor and site.
- Tracks multiple aspects of the study and communicates information to the study team.
- Assists study team in collection of essential documents, IRB submissions, procurement and shipment of supplies to sites.
- Maintains clinical trial master files (TMF) and keeps all documentation current.
- Responsible for internal filing and tracking of study-related and investigator-related documentation.
- Assists with inventory of site specific and protocol specific files.
- Assists in generation and tracking of investigator payments.
- As directed by the Study manager, may communicate with site staff regarding the collection and status of essential documents, study supplies, mass communications and other study related information and actions.
- Assists with review of both internal and external documents, including essential documents and IRB applications.
- Develops and provides reports to update and summarize study progress and status.
- Provides meeting agendas, minutes and action items for study related meetings.
- Provides administrative support and coordinates study team activities on behalf of the Study Manager.
- Performs other tasks as directed by line management or project leadership.
- This position requires a B.S./B.A. (health related or scientific discipline preferred) or minimum of 4 years administrative or technical/scientific experience, or equivalent combination of education and experience.
- Competent computer skills including MS Office Suite.
- Experience working in a regulated environment such as a CRO or pharmaceutical company is preferred.
Skills & Attributes:
- Customer service oriented.
- Demonstrated good communication skills (written and verbal).
- Attention to detail.
- Manner of interactions demonstrates an understanding of the value of developing positive relationships.
- Ability to plan and organize information and activities as directed by a Study Manager or team member.
- Able to resolve routine problems and elevate issues appropriately.
- Able to work in a fast paced environment that requires effective multi-tasking and ability to easily adapt to changing priorities.
- Proficiency in some software system(s) as appropriate for needs of department.
- Possesses active listening skills and proactively seeks clarification and additional information as needed.
- Works well as part of a dynamic project team, actively supporting other team members and identifying opportunities to contribute.