Clinical Trial Associate (440814)
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POST DATE 9/13/2016
END DATE 10/12/2016
JOB DESCRIPTIONJob Description:
OVERVIEW: Essential Duties:Drafts agendas and minutes for internal Study Team meetingsResponsible for maintaining key study trackers, including; Site Contact Lists, Site Question & Answer Logs, and Site Budgets Log.Assists in creation, shipment and update of Investigator Site Files, including printing of required study documentsTracks required documentation from clinical sites prior to study start-up.Reviews informed consents for accuracy, adherence to federal regulations.Assists in drafting study plans, including; Clinical Monitoring, Safety, Medical Monitoring and Trial Management.Assists in vendor management, including the efficient use of web tools such as IWRS, IRB web portals and central lab web portals to track the progress of studies and to ensure the studies are running smoothly.Reviews data queries for accuracy and consistency prior to distribution to clinical sites.Maintains complete and accurate clinical study documentation.Represents Client in a professional manner; establishes and maintains good relationships with investigators and all other study personnel.Assists in Investigator Meeting planning.Performs additional study related functions as required, e.g., preparation of and tracking payments to investigators, and participation in clinical project planning.Supports the maintenance of the clinical dashboard Other Duties: Attend Clinical Operations Staff Meeting as needed. Support clinical documents filing Education:BS/BA in biological or scientific discipline; nursing or experience with management of clinical trials. Special skills/knowledge:Must have at least two years' experience with setting up meetings, generate meeting minutes, assist with start-up and maintenance of studiesShould have solid experience with CTMS, eTMF, regulatory tracker, site payment and invoice processing, and device tracking etc.Effective communications skills.Excellent organizational skills.Working knowledge of the Microsoft Office Suite (i.e., Word, Excel, Access, PowerPoint)Familiar with database construction.Excellent attention to detail.Self-motivated, assertive and able to function both independently and as a team member.Strong interpersonal skills.
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