This position supports clinical studies from study start-up through close-out. The Clinical Study Assistant is responsible for supporting Clinical Operation Managers (COM) and Clinical Research Associates (CRA), to ensure clinical study documentation (trial master file) is complete, accurate and on file according to standard operating procedure, as well as assist with clinical trial progress tracking and reporting as required.
ESSENTIAL FUNCTIONS
Enter and maintain required documentation in study specific databases related to purchases, contracts, health care compliance, study document management, and other areas as required
Responsible for the set-up of the Trial Master File, investigator study file binders and regulatory document collection
Review protocols and study documents to ensure consistency and accuracy
Coordinate and plan investigator meetings, site training, and other company functions
File and review all appropriate test article accountability reconciliation form from study sites
Other duties as assigned
RESPONSIBILITIES
The expectation is that this position can independently handle collecting legal documents and contracts through the appropriate channels to be approved and payments initiated. Invoices must be collected, quality checked, and reconciled against milestones stated in the applicable contracts per Sarbanes Oxley.
Using the appropriate system applications, this position is accountable for the following activities:
Obtain CR (Protocol) number
Create Trial Master File
Generate site regulatory binders
Perform debarment checks
Review, track, scan and upload regulatory documents to eTMF, and file in TMF
Schedule and set up Site Initiation Training meetings
Work with on-site printing vendor as required to generate study documents (e.g., ICFs, assents, questionnaires, instructions)
Request and submit Research Agreements for approval
Field all study-related questions and document in communication file in TMF
Regular TMF review
Schedule meetings, generate and publish meeting minutes
Keep calendar
Create transaction records in and upload documents to the appropriate systems
Format and finalize draft protocols to Regulatory and SOP standards
Initiate document review, approval and finalizing processes
Track, reconcile, and report budget and payments
Supplier set up and database maintenance
QUALIFICATIONS
Bachelor's degree or higher from an accredited institution and 1-2 years' Clinical Trial Coordinator I, or 3+ years' related clinical experience.
Strong organizational skills
Computer skills required:
Microsoft Office products - Word, Excel, PowerPoint, Project, and SharePoint
Ability to work with minimal supervision in a Team environment
The ability to understand written work instructions and follow the requirements
Highly developed communication skills to include all levels of an organization
1 year leadership experience preferred
Knowledge of FDA guidelines, regulations and/or Good Clinical Practice a strong plus