Clinical Trial Specialist
Caris Life Sciences
2 months ago
On-site
Phoenix, AZ
Clinical Research and Development
Position Summary
A Clinical Trial Specialist 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 include study documentation maintenance, IRB submissions, site onboarding, site engagement (status meetings/touch points), study enrollment/accrual reporting, specimen tracking, accessioning, and inventory.
Job Responsibilities
- Execute site onboarding effectively and timely
- Understand study content, workflows, and procedures; conduct Site Initiation Visit and provide ongoing site support
- Monitor and facilitate local and central IRB activities (additional submissions, amendments/changes, annual continuing review reports, document expiration notifications, processing fees)
- Create new study and site Trial Master File (TMF) entries, including site information and required documents
- Ensure regulatory, legal, and financial disclosure documentation is on file per SOPs/data management plan/protocol
- Maintain operational study documents (SOPs, Working Instructions, Lab Manuals, User Guides, and study forms including tracking, maintenance, instrument logs, quality assessments, reports, audits)
- Communicate cross-functionally on operational changes and ensure questions/issues are addressed
- Ensure sample integrity and maintain GCP compliance (chain of custody, handling guidelines, storage); perform sample tracking/reporting data entry, inventory, distribution, and stakeholder updates
- Oversee shipment tracking, receipt, storage/inventory, maintenance, and transfer/distribution of non-clinical samples and clinical biospecimens
- Maintain workflows per approved SOPs; support process improvement
- Review specimen requests for approvals, maintain chain-of-custody documentation, and route for fulfillment
- Enter specimen information into the Sample Management System
- Review specimen submission documentation and verify data entry accuracy
- Coordinate and assist with deidentification of specimen requests
Required Qualifications
- Associate degree or higher with biological science coursework
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
- 1–2 years’ experience in a biorepository or clinical trial setting
- Experience handling human biological materials
- Effective, respectful communication with coworkers, staff, sponsors, and clients
- Excellent customer service
- Strong organization and time management; ability to work independently and with direction
- Attention to detail and problem-solving skills
- Ability to multi-task in a fast-paced, deadline-driven environment
- Results-oriented focus on service, quality, and continuous improvement
Preferred Qualifications
- Prior biorepository or clinical trial experience
- Experience with clinical trial regulatory documentation or TMF
- Strong understanding of laboratory settings/processes; adaptable to varying workloads
- Laboratory Information Management System or Sample Management System experience
- Customer service experience
- Good Clinical Practice, IATA, and Human Subject Protection training
Physical Demands
- Ability to stand and sit for more than 1 hour at a time
- Ability to lift up to 30 lbs
Training
- Required: Good Clinical Practices, Human Subject Protection, HIPAA, and IATA training
- Additional job-specific safety/compliance training assigned based on role functions
Other
- Some evenings, weekends and/or holidays
Conditions of Employment
- Complete pre-employment process including criminal background check, drug screening, credit check (for certain positions), and reference verification
A Clinical Trial Specialist 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 include study documentation maintenance, IRB submissions, site onboarding, site engagement (status meetings/touch points), study enrollment/accrual reporting, specimen tracking, accessioning, and inventory.
Job Responsibilities
- Execute site onboarding effectively and timely
- Understand study content, workflows, and procedures; conduct Site Initiation Visit and provide ongoing site support
- Monitor and facilitate local and central IRB activities (additional submissions, amendments/changes, annual continuing review reports, document expiration notifications, processing fees)
- Create new study and site Trial Master File (TMF) entries, including site information and required documents
- Ensure regulatory, legal, and financial disclosure documentation is on file per SOPs/data management plan/protocol
- Maintain operational study documents (SOPs, Working Instructions, Lab Manuals, User Guides, and study forms including tracking, maintenance, instrument logs, quality assessments, reports, audits)
- Communicate cross-functionally on operational changes and ensure questions/issues are addressed
- Ensure sample integrity and maintain GCP compliance (chain of custody, handling guidelines, storage); perform sample tracking/reporting data entry, inventory, distribution, and stakeholder updates
- Oversee shipment tracking, receipt, storage/inventory, maintenance, and transfer/distribution of non-clinical samples and clinical biospecimens
- Maintain workflows per approved SOPs; support process improvement
- Review specimen requests for approvals, maintain chain-of-custody documentation, and route for fulfillment
- Enter specimen information into the Sample Management System
- Review specimen submission documentation and verify data entry accuracy
- Coordinate and assist with deidentification of specimen requests
Required Qualifications
- Associate degree or higher with biological science coursework
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
- 1–2 years’ experience in a biorepository or clinical trial setting
- Experience handling human biological materials
- Effective, respectful communication with coworkers, staff, sponsors, and clients
- Excellent customer service
- Strong organization and time management; ability to work independently and with direction
- Attention to detail and problem-solving skills
- Ability to multi-task in a fast-paced, deadline-driven environment
- Results-oriented focus on service, quality, and continuous improvement
Preferred Qualifications
- Prior biorepository or clinical trial experience
- Experience with clinical trial regulatory documentation or TMF
- Strong understanding of laboratory settings/processes; adaptable to varying workloads
- Laboratory Information Management System or Sample Management System experience
- Customer service experience
- Good Clinical Practice, IATA, and Human Subject Protection training
Physical Demands
- Ability to stand and sit for more than 1 hour at a time
- Ability to lift up to 30 lbs
Training
- Required: Good Clinical Practices, Human Subject Protection, HIPAA, and IATA training
- Additional job-specific safety/compliance training assigned based on role functions
Other
- Some evenings, weekends and/or holidays
Conditions of Employment
- Complete pre-employment process including criminal background check, drug screening, credit check (for certain positions), and reference verification