eTMF & Clinical Study Documentation Specialist

Caris MPI, Inc.; Irving (TX); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Health Savings Account

Flexible Spending Account

Paid time off

401k match

LTD and STD insurance

Employee Assistance Program

Pet Insurance

Legal Assistance

Tuition Assistance

Job summary

Caris Life Sciences is seeking a Clinical Study Documentation Specialist to provide study support for Caris-sponsored studies and collaborative pharmaceutical research initiatives. The role aligns with SOPs, regulatory requirements, and industry best practices.

You will maintain study documentation, coordinate IRB submissions, engage with research sites, and ensure documents are current, complete, and compliant throughout the trial lifecycle.

Qualifications

• Associates degree with 2 years experience preparing and submitting documents to IRBs.
• Strong understanding of clinical research documentation and regulatory processes.
• Proficient in Microsoft Office and capable of navigating internet-based regulatory/trial 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 background check, drug screening, and reference check.

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 inspection readiness.
• Coordinate and conduct regular reviews of study binders and systems to ensure documents are non-expired and aligned with protocol requirements.
• Serve as a liaison between internal teams, sites, IRBs, and sponsors to facilitate communication and timely regulatory submissions.
• Track study progress in CTMS, IRB portals, spreadsheets, and sponsor systems; update milestones and document statuses.
• Assist with site onboarding and study activation, providing guidance and support throughout the trial lifecycle.
• Participate in meetings to provide updates on study status and documentation timelines.
• Support compliance with regulatory guidelines (GCP, HIPAA, FDA, OHRP) and changes in processes.
• Assist with development and delivery of GCP training for internal stakeholders and staff.

Skills

Clinical research documentation

IRB submissions

Regulatory compliance

Documentation management

Communication

Education

Associate's degree

Bachelor's degree (preferred)

Tools

Microsoft Office

Job description

Caris Life Sciences is seeking a Clinical Study Documentation Specialist to provide study support for Caris-sponsored studies and collaborative pharmaceutical research initiatives. The role aligns with SOPs, regulatory requirements, and industry best practices.

You will maintain study documentation, coordinate IRB submissions, engage with research sites, and ensure documents are current, complete, and compliant throughout the trial lifecycle.