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 activities are 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 assessing clinical study documents to confirm that they are current, complete, and compliant.

The position supports study initiation, maintenance, onboarding, and activation; maintains study files and systems; coordinates with internal teams, research sites, IRBs, and sponsors; and helps ensure compliance with applicable regulations and guidelines. It also assists with GCP training and the development of processes or SOPs as needed. The role may require responding to urgent regulatory issues after hours in rare cases.

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.
• Completion of Good Clinical Practices (GCP), Human Subject Protection, and HIPAA training.
• Ability to sit or stand for prolonged periods (more than one hour at a time).
• Ability to lift up to 30 lbs as needed.

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 clinical study documents—including protocols, informed consent forms, investigator brochures, and amendments—to IRBs and other oversight entities.
• Maintain accurate, up-to-date 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.
• Liaise with internal teams, research sites, IRBs, and sponsors to facilitate communication, resolve issues, and support timely regulatory submissions and approvals.
• Track study progress in applicable databases and platforms, updating milestones and document statuses in CTMS, IRB portals, spreadsheets, and sponsor systems as required.
• Assist with site onboarding and study activation, and provide study 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 federal, state, and local regulations and applicable GCP, HIPAA, FDA, OHRP, and other guidelines.
• Assist with developing and delivering GCP training for internal stakeholders and research staff.
• Maintain awareness of changes in clinical regulatory processes and assist with 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
• Education Level: Associate degree