Clinical Study Assistant

2 days ago

Jacksonville, United States Kelly Science, Engineering, Technology & Telecom Full time

Clinical Study Assistant


SUMMARY


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:

  1. 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

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