Sr. Clinical Trials Associate

Glaukos•San Clemente, CA

17h•$66,900 - $83,600

About The Position

The Sr. Clinical Trials Associate is responsible for the coordination of clinical research studies in compliance with U.S. and international regulations under the guidance of a Clinical Manager or Clinical Director.

Requirements

Bachelor's Degree with background in science or equivalent work experience
4 plus years of work experience as a CTA
Understanding of required regulatory documents for the study.
Effective communication and understanding of the role with sites; with both

Responsibilities

Supports with the development of clinical trial protocols
Reviews clinical study data
Assists with development of case report forms
CTA is responsible for effective communication with clinical trial sites
Assists with analyses of study data
Reviews data as it comes in from sites
Documents errors and communicates to Manager
Communicates with sites to correct errors
Assists Manager with study management
Sets up Study Master File and Study Master File Tracker at the beginning of each study
Receives, QC’s, scans and files documents in Study Master File
Provides status of documents to Clinical Management
Communicates directly with site staff to obtain site start-up documents
Prepares Regulatory Binders and provides to sites prior to Site Initiation Visit (SIV)
Obtains site documents from Regional Clinical Research Associates during trial
Receives, QC’s, scans, and files site documents in Study Master File
Provides status of site documents in Study Master File to Regional Clinical Research Associates prior to Monitoring Visits
Establishes and Maintains Tracking of Critical Trial Information
Team and site contact information
Site status information
Enrollment trackers
Adverse event trackers
Site payment trackers and site payments
Scheduling meetings, set up of AV, teleconference or video conference equipment
Preparation of relevant materials
Support IP shipment and shipment of other materials to sites