Clinical Trials Associate II
82.5K–107K a year
Behavioral Health Market Context
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Job Description
h development of case report forms
• CTA is responsible for effective communication with clinical trial sites
• Analyses of study data with support of more experience CTAs or manager
• Reviews and Monitors Clinical Study Data
• Reviews data as it comes in from sites
• Documents errors and communicates to Manager and Director Clinical Operations
• Communicates with sites to correct errors
• Assists Manager with study management
• Study Master File Maintenance
• Sets up Study Master File and Study Master File Tracker at the beginning of each study
• Receives, QC8217;s, scans and files documents in Study Master File
• Provides status of documents to Clinical Management
• Collection of Site Start-Up Documents
• 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, QC8217;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
• Team Support
• Schedules meetings, set up of AV, teleconference or video conference equipment
• Preparation of relevant materials
• Support IP shipment and shipment of other materials to sites
How You'll Get there:
• Bachelor's Degree with background in science, or equivalent work experience Preferred
• CTA1 - 1-2 years experience (Salary Range - 69,000. - 83,500.)
• CTAII 2-5 years clinical work experience in the bio- pharmaceutical or device industry, preferably within the ophthalmology field (posted)
• Sr. CTA 5 plus years experience, ophthalmology experience strongly preferred (Salary Range - 107,700 - 134,600)
• CTA must demonstrate the following: • Understanding of required regulatory documents for the study.
• Effective communication and understanding of the role with sites; with both monitors and CRMs
• CTA is responsible for effective communication with clinical trial sites
• Analyses of study data with support of more experience CTAs or manager
• Reviews and Monitors Clinical Study Data
• Reviews data as it comes in from sites
• Documents errors and communicates to Manager and Director Clinical Operations
• Communicates with sites to correct errors
• Assists Manager with study management
• Study Master File Maintenance
• Sets up Study Master File and Study Master File Tracker at the beginning of each study
• Receives, QC8217;s, scans and files documents in Study Master File
• Provides status of documents to Clinical Management
• Collection of Site Start-Up Documents
• 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, QC8217;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
• Team Support
• Schedules meetings, set up of AV, teleconference or video conference equipment
• Preparation of relevant materials
• Support IP shipment and shipment of other materials to sites
How You'll Get there:
• Bachelor's Degree with background in science, or equivalent work experience Preferred
• CTA1 - 1-2 years experience (Salary Range - 69,000. - 83,500.)
• CTAII 2-5 years clinical work experience in the bio- pharmaceutical or device industry, preferably within the ophthalmology field (posted)
• Sr. CTA 5 plus years experience, ophthalmology experience strongly preferred (Salary Range - 107,700 - 134,600)
• CTA must demonstrate the following: • Understanding of required regulatory documents for the study.
• Effective communication and understanding of the role with sites; with both monitors and CRMs
Qualifications
- •CTA1 - 1-2 years experience (Salary Range - 69,000
- •CTAII 2-5 years clinical work experience in the bio- pharmaceutical or device industry, preferably within the ophthalmology field (posted)
Benefits
Responsibilities
- •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
- •Clinical Trials Coordination
- •Assists 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
- •Analyses of study data with support of more experience CTAs or manager
- •Reviews and Monitors Clinical Study Data
- •Reviews data as it comes in from sites
- •Documents errors and communicates to Manager and Director Clinical Operations
- •Communicates with sites to correct errors
- •Assists Manager with study management
- •Study Master File Maintenance
- •Sets up Study Master File and Study Master File Tracker at the beginning of each study
- •Receives, QC8217;s, scans and files documents in Study Master File
- •Provides status of documents to Clinical Management
- •Collection of Site Start-Up Documents
- •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, QC8217;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
- •Enrollment trackers
- •Adverse event trackers
- •Site payment trackers and site payments
- •Team Support
- •Schedules meetings, set up of AV, teleconference or video conference equipment
- •Preparation of relevant materials
- •Support IP shipment and shipment of other materials to sites
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