Clinical Trial Specialist
Caris Life Sciences
June 26, 2026
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 SOPs and best practices.
Job Responsibilities
- Execute site onboarding and conduct Site Initiation Visit; provide ongoing site support.
- Develop understanding of study workflows/procedures.
- Monitor and facilitate local and central IRB activities (submissions, amendments/changes, continuing review reports, expiration tracking, and fee processing).
- Oversee creation of Trial Master File (TMF) entries (new studies and sites) including required documents.
- Ensure regulatory/legal/financial disclosure documentation is on file per SOPs, data management plan, and/or protocol.
- Maintain operational study documents (SOPs, working instructions, lab manuals, user guides, study forms, tracking, maintenance, instrument logs, quality assessments, reports, audits).
- Communicate cross-functionally on operational changes and resolve questions/issues.
- Maintain sample integrity and GCP compliance (chain of custody, handling, storage, tracking/reporting, inventory, distribution, stakeholder updates).
- Oversee shipment tracking/receipt/storage/inventory and transfer/distribution of non-clinical samples and clinical biospecimens.
- Maintain approved SOP workflows; assist with process improvement.
- Review specimen requests for approvals; maintain chain of custody documentation and fulfillment routing.
- Enter/update specimen data in Sample Management System; review submission documentation for accuracy.
- Coordinate 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; excellent customer service.
- Strong organization/time management; ability to multitask in a fast-paced, deadline-driven environment.
- Attention to detail and problem-solving.
Preferred Qualifications
- Clinical trial regulatory documentation or TMF experience.
- Strong understanding of lab settings/processes.
- LIMS/Sample Management System experience.
- Good Clinical Practice, IATA, and Human Subject Protection training.
Physical Demands
- Stand and sit for more than 1 hour at a time.
- Lift up to 30 lbs.
Training
- Required: Good Clinical Practice, Human Subject Protection, HIPAA, and IATA.
Other
- Some evenings, weekends, and/or holidays.
A Clinical Trial Specialist provides operational and regulatory support for Caris sponsored studies and collaborative Pharma studies, ensuring activities are conducted per SOPs and best practices.
Job Responsibilities
- Execute site onboarding and conduct Site Initiation Visit; provide ongoing site support.
- Develop understanding of study workflows/procedures.
- Monitor and facilitate local and central IRB activities (submissions, amendments/changes, continuing review reports, expiration tracking, and fee processing).
- Oversee creation of Trial Master File (TMF) entries (new studies and sites) including required documents.
- Ensure regulatory/legal/financial disclosure documentation is on file per SOPs, data management plan, and/or protocol.
- Maintain operational study documents (SOPs, working instructions, lab manuals, user guides, study forms, tracking, maintenance, instrument logs, quality assessments, reports, audits).
- Communicate cross-functionally on operational changes and resolve questions/issues.
- Maintain sample integrity and GCP compliance (chain of custody, handling, storage, tracking/reporting, inventory, distribution, stakeholder updates).
- Oversee shipment tracking/receipt/storage/inventory and transfer/distribution of non-clinical samples and clinical biospecimens.
- Maintain approved SOP workflows; assist with process improvement.
- Review specimen requests for approvals; maintain chain of custody documentation and fulfillment routing.
- Enter/update specimen data in Sample Management System; review submission documentation for accuracy.
- Coordinate 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; excellent customer service.
- Strong organization/time management; ability to multitask in a fast-paced, deadline-driven environment.
- Attention to detail and problem-solving.
Preferred Qualifications
- Clinical trial regulatory documentation or TMF experience.
- Strong understanding of lab settings/processes.
- LIMS/Sample Management System experience.
- Good Clinical Practice, IATA, and Human Subject Protection training.
Physical Demands
- Stand and sit for more than 1 hour at a time.
- Lift up to 30 lbs.
Training
- Required: Good Clinical Practice, Human Subject Protection, HIPAA, and IATA.
Other
- Some evenings, weekends, and/or holidays.