Clinical Trial Specialist - Biorepository

Role Summary

A Clinical Trial Specialist-Biorepository provides operational and regulatory support for Caris-sponsored studies and collaborative pharma studies, ensuring activities are conducted per standard operating procedures and best-practice principles. Responsibilities will include, but are not limited to, study documentation maintenance, leading site onboarding activities, driving site engagement through routine status meetings, study enrollment/accrual reporting, specimen tracking, and inventory management.

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
• Required: Candidates should have 1-2 years’ 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’ experience
• Preferred: Candidates should have experience with clinical trial regulatory documentation or TMF
• Preferred: 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
• 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

Education

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

Additional Requirements

• Physical Demands: Ability to stand for more than 1 hour at a time, sit for more than 1 hour at a time, and lift up to 30 lbs
• Training: Employee will be required to complete Good Clinical Practices, Human Subject Protection, HIPAA, and IATA training
• Training: All job-specific, safety, and compliance training are assigned based on the job functions associated with this employee
• Other: Weekend/evening/holiday work may be required depending on business need, however, is not to be the norm
• Conditions of Employment: Pre-employment process, including criminal background check, drug screening, and reference verification (credit check where applicable)