Clinical Trial Specialist - Biorepository

Role Summary

A Clinical Trial Specialist-Biorepository provides operational and regulatory support for the Caris sponsored studies and collaborative Pharma studies ensuring activities are conducted per standard operating procedures and best practice principles.

Responsibilities

• Successfully execute site onboarding process in an effective and timely manner
• Develop and maintain a thorough understanding of study content, workflows, and procedures to successfully conduct the Site Initiation Visit meeting and offer ongoing site support
• Liaison with study sites and regulatory document team to ensure regulatory documentation is up to date
• Ensures proper regulatory, legal, and financial disclosure documentation are on file in accordance with standard operating procedures, data management plan and/or study protocol
• Communicates cross functionally (internally and externally) on all research study operational changes; ensuring questions and issues are answered/addressed or provided to the appropriate group
• Maintains workflows in accordance with approved Standard Operating Procedures (SOPs). Assists in process improvement within the department under the direction of manager
• Reviews specimen requests for proper approvals, maintains documentation of chain of custody, and routes for fulfillment
• Reviews associated specimen and subject submission documentation and verified accuracy of data entry
• Continuously provides excellent customer service in an efficient and effective manner

Qualifications

• Associate degree with biological science coursework required
• Candidates should have 1-2 years‚Äô experience in a Biorepository setting or Clinical Trial setting
• Proficient in Microsoft Office Suite, specifically Word, Excel, PowerPoint, Outlook, and general working knowledge of Internet for business use
• BS degree or higher degree with biological science
• 3-5 years‚Äô experience
• Candidates should have experience with clinical trial regulatory documentation or TMF
• Candidates should have a strong understanding of laboratory settings and processes and must be able to adapt to varied levels of workload in a dynamic environment
• Laboratory Information Management System or Sample Management System experience
• Customer service experience
• Good Clinical Practice training, IATA training, and Human Subject Protection training

Skills

• Regulatory documentation management
• Site onboarding and initiation support
• Data entry accuracy and specimen handling
• Cross-functional communication
• Customer service orientation

Education

• Associate degree in biological sciences required; BS or higher preferred

Additional Requirements

• Physical demands: ability to stand or sit for extended periods; ability to lift up to 30 lbs
• Training: Good Clinical Practices, Human Subject Protection, HIPAA, and IATA training
• Other: occasional weekend/evening/holiday work may be required depending on business need