Clinical Study Documentation Specialist

Caris Life Sciences • Phoenix, AZ

1d

About The Position

The Clinical Study Documentation Specialist provides clinical study support for Caris-sponsored studies and collaborative pharmaceutical research initiatives. The role’s work is conducted in alignment with internal standard operating procedures, 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 assessing clinical study documents to confirm they are current, complete, and compliant.

The specialist supports study initiation and maintenance by preparing and submitting documents to IRBs and other oversight entities, maintaining study files, tracking study progress in applicable systems, and serving as a liaison among internal teams, sites, IRBs, and sponsors. The role also supports site onboarding and activation, study-related meetings, regulatory compliance, GCP training, and the development of processes or SOPs as needed. Occasional after-hours response may be needed for urgent regulatory support.

Requirements

• Associate degree.
• Two years of experience preparing and submitting documents to Institutional Review Boards (IRBs).
• Strong understanding of clinical research documentation, clinical regulatory processes, and protocol development.
• Proficiency in Microsoft Office Suite, including Word, Excel, and Outlook, and ability to navigate internet-based regulatory and trial management systems.
• 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.
• Complete Good Clinical Practices (GCP), Human Subject Protection, and HIPAA training, along with job-specific, safety, and compliance training assigned for the role.

Nice To Haves

• 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.

Responsibilities

• Prepare and submit protocols, informed consent forms, investigator brochures, and amendments to IRBs and other oversight entities.
• Maintain accurate, current clinical study files and documentation, including licenses, staff certifications, training records, and equipment logs, so required elements are available for inspection or audit.
• Coordinate and conduct regular reviews of study binders and systems to ensure documents are current, complete, and aligned with protocol requirements.
• Act as a liaison among internal teams, research sites, IRBs, and sponsors to facilitate communication, resolve issues, and support timely regulatory submissions and approvals.
• Track study progress, milestones, and document statuses in clinical trial management systems, IRB portals, spreadsheets, and sponsor systems.
• Assist with site onboarding and study activation, providing guidance and support throughout the trial lifecycle.
• Participate in internal and external meetings, including site calls and sponsor touchpoints, and provide updates on study status and documentation timelines.
• Support compliance with applicable federal, state, and local regulations and guidelines, including GCP, HIPAA, FDA, and OHRP requirements.
• Assist with developing and delivering GCP training for internal stakeholders and research staff.
• Stay aware of changes in clinical regulatory processes and assist in developing new processes or SOPs as needed.
• Respond to after-hours issues in rare cases when urgent regulatory support is required.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree