Clinical Study Documentation Specialist

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Position SummaryThe 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.

Physical Demands

• Ability to sit or stand for prolonged periods (more than 1 hour at a time).

• Ability to lift up to 30 lbs as needed.

Training

• Completion of Good Clinical Practices (GCP), Human Subject Protection, and HIPAA training.

• All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

Other

• Availability to respond to after-hours issues in rare cases where urgent regulatory support is required.

Conditions of Employment:  Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check( applicable for certain positions) and reference verification.

This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.