Job Description
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.
Qualifications
What You’ll Do:
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.
- Clinical Trials Coordination
- Integral part of development of clinical trial protocols
- Reviews clinical study data
- Development of case report forms
- CTA is responsible for effective communication with clinical trial sites
- Uses gained experience to give high level analyses of study data
- Reviews and Monitors Clinical Study Data
- Reviews complex data as it comes in from sites
- Documents errors and communicates to Manager and Director Clinical Operations
- Communicates with sites to correct errors
- Works with 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, 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, 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
- Leads meetings internally and for investigative sites.
- Perform site co-monitoring activities as needed.
- Supports internal and external audits.
- 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
- 5-8 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 required
