• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• Maintains and coordinates the administrative aspects of lntegra's Clinical Affairs dept. including clinical studies according to GCPs and S0 Ps.
• Provides support for the preparation of clinical study reports, annual reports, interim updates and other study or regulatory documents, as required
• Works with study teams to prepare clinical study documents, including investigator meeting materials, site and training information
• Serves as a resource for clinical study sites and can triage questions/needs, as appropriate
• Implements and maintains clinical filing systems for all shared documents and files and proactively identifies operational process improvements
• Files and maintains study documents in the study Trial Master Files (TMFs)
• Performs ongoing and final study-level and site-level TMF reconciliation
• Performs data entry into designated clinical tracking systems in accordance with project requirements, including collection of information from designated clinical team members, CRO's, vendors, etc.
• Assists with the processing of both vendor and site payments
• Assists with gathering and tracking clinical trial accruals
• Provides accurate progress reports on assigned tasks and projects
• Contributes to wider organizational goals and/or activities as assigned
• Ensures study compliance by understanding and applying all relevant SOPs
• Performs various administrative duties such as travel arrangements, expense reporting, meeting minutes and other administrative duties for the department as needed.
• Works with department staff to support and achieve department objectives.
• Works with Global Clinical Affairs members at other locations to coordinate and streamline clinical operations worldwide.
• Minimum of a Bachelor degree in a relevant scientific and/or financial discipline Experience: 2 years relevant (clinical research and/or finance) experience
• Strong written and verbal communication skills
• Demonstrated organizational skills
• Ability to work independently in a fast-paced team environment
• Computer software: Microsoft Word, Excel, PowerPoint, Project, Visio
• Experience using a document management system preferred
• Basic knowledge and understanding of pharmaceutical regulatory requirements, including FDA and ICH guidelines would be a plus.