Clinical Study Documentation Specialist
Caris Life Sciences
4 hours ago
Remote friendly (Phoenix, AZ)
United States
Clinical Research and Development
Position Summary
The Clinical Study Documentation Specialist provides clinical study support for Caris-sponsored studies and collaborative pharmaceutical research initiatives, ensuring activities align with internal SOPs, regulatory requirements, and industry best practices.
Responsibilities
- Support clinical trial initiation and maintenance by preparing and submitting study documents (protocols, informed consent forms, investigator brochures, and IRB amendments).
- Maintain accurate, up-to-date study files and documentation (licenses, staff certifications, training records, equipment logs) for inspection/audit.
- Review study binders/systems to ensure documents are non-expired, complete, and protocol-aligned.
- Serve as a liaison among internal teams, research sites, IRBs, and sponsors; resolve issues and support timely submissions/approvals.
- Track study progress and update milestones/document statuses in CTMS, IRB portals, spreadsheets, and sponsor systems.
- Support site onboarding and study activation.
- Participate in internal/external meetings (site calls and sponsor touchpoints) and provide study/documentation timelines.
- Support compliance with GCP, HIPAA, FDA, OHRP, and other applicable guidelines.
- Assist in GCP training development/delivery and support updates to processes/SOPs.
Required Qualifications
- Associate’s degree.
- 2 years preparing/submitting documents to IRBs.
- Strong knowledge of clinical research documentation, regulatory processes, and protocol development.
- Proficiency in Microsoft Office (Word/Excel/Outlook); ability to navigate internet-based regulatory/trial systems.
- Strong organization and attention to detail; ability to manage multiple studies with minimal supervision.
Preferred Qualifications
- Working knowledge of ICH-GCP/FDA/DHHS/OHRP.
- Bachelor’s degree; 2+ years in clinical research/regulatory environment.
- CTMS experience; CCRC/CCRP/RAC certifications (plus).
Training
- Complete GCP, Human Subject Protection, and HIPAA training.
The Clinical Study Documentation Specialist provides clinical study support for Caris-sponsored studies and collaborative pharmaceutical research initiatives, ensuring activities align with internal SOPs, regulatory requirements, and industry best practices.
Responsibilities
- Support clinical trial initiation and maintenance by preparing and submitting study documents (protocols, informed consent forms, investigator brochures, and IRB amendments).
- Maintain accurate, up-to-date study files and documentation (licenses, staff certifications, training records, equipment logs) for inspection/audit.
- Review study binders/systems to ensure documents are non-expired, complete, and protocol-aligned.
- Serve as a liaison among internal teams, research sites, IRBs, and sponsors; resolve issues and support timely submissions/approvals.
- Track study progress and update milestones/document statuses in CTMS, IRB portals, spreadsheets, and sponsor systems.
- Support site onboarding and study activation.
- Participate in internal/external meetings (site calls and sponsor touchpoints) and provide study/documentation timelines.
- Support compliance with GCP, HIPAA, FDA, OHRP, and other applicable guidelines.
- Assist in GCP training development/delivery and support updates to processes/SOPs.
Required Qualifications
- Associate’s degree.
- 2 years preparing/submitting documents to IRBs.
- Strong knowledge of clinical research documentation, regulatory processes, and protocol development.
- Proficiency in Microsoft Office (Word/Excel/Outlook); ability to navigate internet-based regulatory/trial systems.
- Strong organization and attention to detail; ability to manage multiple studies with minimal supervision.
Preferred Qualifications
- Working knowledge of ICH-GCP/FDA/DHHS/OHRP.
- Bachelor’s degree; 2+ years in clinical research/regulatory environment.
- CTMS experience; CCRC/CCRP/RAC certifications (plus).
Training
- Complete GCP, Human Subject Protection, and HIPAA training.