Clinical Trials Associate - Multiple Levels Available

How will you make an impact?

The Clinical Trials Associate/CTAII/ SR CTA/SR CTAII/Principal CTA 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 will you do?

Clinical Trials Coordination

• 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 and Monitors Clinical 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
   

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
• 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, 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
   

Team Support

• 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

How will you get here?

 

CTA

• Bachelor's Degree with background in science or equivalent work experience preferred
• 2 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

CTA II 

• Bachelor's Degree with background in science, or equivalent work experience 
• 2-5 years clinical work experience in the pharmaceutical or device industry, preferably within the ophthalmology field  
• 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

Senior CTA 

• Bachelor's Degree with background in science  or equivalent work experience 
• 4-8 years of work experiences as CTA in ophthalmic field Required 
• Sr. CTA must demonstrate the following: 
• May have specific expertise i.e. systems subject matter expert, regulatory knowledge
• Ability to identify gaps and address them.
• Understanding of the studies assigned; for instance can perform data cleaning. 
• Leading meetings internally and for investigative sites. 
• Able to perform site co-monitoring activities as needed.
• Support internal and external audits

Senior CTAII

• Bachelor's Degree required 
• 8-12 years of work experiences as CTA in ophthalmic field 
• Sr. CTA must demonstrate the following: May have specific expertise i.e. systems subject matter expert, regulatory knowledge.  
• Ability to identify gaps and address them.   
• Understanding of the studies assigned; for instance, can perform data cleaning.   
• Leading meetings internally and for investigative sites.   
• Able to perform site co-monitoring activities as needed.   
• Support internal and external audits. 

Principal: 

• Bachelor's Degree with background in science or equivalent work experience
• 12+ years of experience as a CTA in ophthalmic field 
• Principal CTA must demonstrate the following: 
• Specific expertise within department i.e. mentor / train new CTAs. 
• May lead projects or project module. 
• Make presentations internally and for investigative sites. 
• Able to perform site monitoring activities as needed. 
• Familiarity with clinical trials study documentation 
• Excellent problem solving and analytical skills (ability to interpret and summarize data, perform basic statistics)