Clinical Study Documentation Specialist

Position Summary

The Clinical Study Documentation Specialist provides clinical study support for Caris-sponsored studies and collaborative pharmaceutical research initiatives. The activities in this role will be conducted in alignment with internal standard operating procedures (SOPs), regulatory requirements, and industry best practices. Responsibilities include maintaining study documentation, coordinating Institutional Review Board (IRB) submissions, engaging with research sites through regular meetings, and regular assessments of clinical study documents to confirm they are current, complete, and compliant.

Job Responsibilities

• Support initiation and maintenance of clinical trials by preparing and submitting study documents including protocols, informed consent forms, investigator brochures, and amendments to IRBs and other oversight entities.
• Maintain accurate and up-to-date clinical study files and documentation, including licenses, staff certifications, training records, and equipment logs, ensuring all required elements are readily available for inspection or audit.
• Coordinate and conduct regular reviews of study binders and systems to ensure documents are non-expired, complete, and aligned with protocol requirements.
• Serve as a liaison between internal teams, research sites, IRBs, and sponsors to facilitate clear communication, resolve issues, and ensure timely regulatory submissions and approvals.
• Track study progress in applicable databases and platforms, updating milestones and document statuses in clinical trial management systems (CTMS), IRB portals, spreadsheets, and sponsor systems as required.
• Assist with site onboarding and study activation, providing study guidance and support throughout the trial lifecycle.
• Participate in internal and external meetings, including site calls and sponsor touchpoints, to provide updates on study status and clinical study documentation timelines.
• Support compliance with federal, state, and local regulations, as well as GCP, HIPAA, FDA, OHRP, and other applicable guidelines.
• Assist with the development and delivery of GCP training for internal stakeholders and research staff.
• Maintain awareness of changes in clinical regulatory processes and assist in the development of new processes or SOPs as needed.

Required Qualifications

• Associates degree
• 2 years experience with preparing and submitting documents to Institutional Review Boards (IRBs).
• Strong understanding of clinical research documentation, clinical regulatory processes, and protocol development.
• Proficient in Microsoft Office Suite (Word, Excel, Outlook) and capable of navigating internet-based systems for regulatory and trial management.
• Strong organizational skills and attention to detail in documentation and communication.
• Ability to manage multiple studies and competing priorities with minimal supervision.
• Successful completion of pre-employment requirements including criminal background check, drug screening, and reference check.

Preferred Qualifications

• Working knowledge of ICH-GCP, FDA, DHHS, and OHRP regulations and guidelines.
• Bachelor's degree in life sciences, healthcare, or a related field.
• At least two years of experience in a clinical research or regulatory environment.
• Experience working with electronic clinical trial management systems (CTMS).
• Certifications such as CCRC, CCRP, or RAC are a plus.