Purpose:

• Provide clinical study team administrative support to ensure compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards and Client’s Standard Operating Procedures. Primary area of focus related to clinical study(ies) may include maintaining study regulatory binder, site regulatory documents, device shipping and tracking and as required assistance with core labs which may include data tracking and preparation of invoices. Collaborate with the In-house Clinical Research Associate and/or Project Manager regarding study or site management needs.

Responsibilities:

• Create and manage site regulatory/subject binder(s) as well as other study related documents and ship to sites.
• Assist with study website, as requested.
• Set-up and maintain site study files including the review and tracking of essential study site documents.
• Quality review and filing of site and sponsor correspondence in the Trial Master File.
• Contribute to and assist with site audit readiness, when requested.
• Track regulatory submission and correspondence on essential study site documents.
• Collect/organize investigator and site information and prepare/follow-up on site activation documents, when requested.
• Track study related information (site/study status, enrollment, IRB/EC status, regulatory documents), when requested.
• Manage the order and release of clinical demo device inventory and special study supplies.
• Provide advice on best practices leveraging standardizing tools across clinical trials.
• May assist with development of study site communication such as newsletters and other correspondence.
• Support and track shipment of project related equipment/data between research sites, sponsor and core labs, when requested.
• Attend project related meetings; schedule room and teleconference, create an agenda and write meeting minutes, as applicable.
• Responsible for archiving of study records per Client’s records retention policy
• May assist with site activation and closure activities, as required.
• Able to handle multiple assignments in a timely manner and problem solve while meeting assigned deadlines under management oversight.
• Communicate and collaborate with all levels of employees, customers, contractors, and vendors.
   

Qualification:

• High school diploma/secondary school degree
• One-year clinical research experience or related device/pharmaceutical experience or relevant clinical experience in a clinical/hospital environment.
• Knowledgeable in operating a personal computer and in using various PC-based software packages including MS Word, Excel, or similar word processing/spreadsheet software.
• Must have strong organizational skills and attentiveness to detail.