All operational areas of clinical research are available for hire on a temporary basis ranging from high level Strategic Product Development Consultation to lower level support staffing, as a part of our COA (Clinical Operations Associates) Program.
Our COA program includes in house support of clinical trials and can be customized to meet your changing needs. Our trained staff is capable of complementing your Project Management, Clinical, Medical, Regulatory, Data and Safety teams in a variety of ways and will work in-house for you on your schedule and at your direction.
We ensure that each COA has the proper qualifications necessary to successfully complete each project assignment. These requirements include an RN/Bachelor degree in Biological Science or related field, relevant industry experience, strong problem-solving skills, excellent organization and written communication skills, and above all, strong interpersonal skills to facilitate blending into your company culture.
Our COA Services include:
Study Document Processing
- Regulatory Documents
- Investigator Study Files and Binders
- Study File Reconciliation audits
Project Management Support
- Project Status Reports
- Track Subject Recruitment/Enrolment
- Prepare/Distribute Study Newsletters
Data Management Support
- Generate and track Data Queries
- Quality Control review of Critical & non-Critical data
Serious Adverse Event (SAE) processing
- Coordinate SAE review process
- Provide SAE Tracking reports
- Perform Safety Review of AE data
- Perform Safety Review of Lab Data
- Coordinate IND Safety Updates
Study Supply Maintenance
- Coordinate Drug/Device Shipments
- Coordinate Laboratory Shipments
- Coordinate Study Supplies and Equipment
- Reconcile Unused Drug/Devices Supplies
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