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 will include, but not limited to, study documentation maintenance, leading site onboarding activities, driving site engagement through routine status meetings/ touch points, study enrollment/ accrual reporting, specimen tracking, and inventory.

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

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

Skills

• Regulatory and documentation management
• Site onboarding and stakeholder coordination
• Data entry and accuracy
• Communication and cross-functional collaboration

Education

• Associate degree with biological science coursework (required)
• BS degree or higher (preferred)

Additional Requirements

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