Clinical Trials Associate II
About The Position
The Clinical Trials Associate II 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. What you will you: Clinical Study Preparation and Maintenance Assists with review of clinical trial protocols Assists with development/review of source documents Assists with preparation of Informed Consent Forms Assists with development of recruitment materials and study tools Works with cross functional team members as assigned Works with study vendors as assigned Collection and Review of Site Start-Up Documents Communicates directly with site staff to obtain site start-up documents Negotiates study contract and budget Prepares Regulatory Binders and provides to sites prior to Site Initiation Visit (SIV)Receives, QC’s, and files site documents in Study Master File Provides status of site documents in Study Master File to Clinical Research Associates (CRAs) prior to Monitoring Visits Clinical Site Management CTA is responsible for effective communication with clinical trial sites Obtains site documents from Clinical Research Associates during trial Addresses inquiries from sites and CRAs Escalates issues to study management as needed Study Master File Maintenance 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 Establishes and Maintains Tracking of Trial Information Team and site contact information Site status information Equipment and supplies Enrollment trackers Adverse event trackers Site payment trackers and site payments
Requirements
- Bachelor's Degree with background in science, or equivalent work experience preferred
- 2-5 years clinical work experience in the bio- pharmaceutical or device industry, preferably within the ophthalmology field
Responsibilities
- Assists with review of clinical trial protocols
- Assists with development/review of source documents
- Assists with preparation of Informed Consent Forms
- Assists with development of recruitment materials and study tools
- Works with cross functional team members as assigned
- Works with study vendors as assigned
- Communicates directly with site staff to obtain site start-up documents
- Negotiates study contract and budget
- Prepares Regulatory Binders and provides to sites prior to Site Initiation Visit (SIV)
- Receives, QC’s, and files site documents in Study Master File
- Provides status of site documents in Study Master File to Clinical Research Associates (CRAs) prior to Monitoring Visits
- CTA is responsible for effective communication with clinical trial sites
- Obtains site documents from Clinical Research Associates during trial
- Addresses inquiries from sites and CRAs
- Escalates issues to study management as needed
- 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
- Establishes and Maintains Tracking of Trial Information
- Team and site contact information
- Site status information
- Equipment and supplies Enrollment trackers
- Adverse event trackers
- Site payment trackers and site payments
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
