Clinical Study Documentation Specialist – eTMF Specialist

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $65k - $85k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 Ghost score 0%

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Caris Life Sciences

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2008

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Caris Life Sciences is a leading innovator in the field of molecular science, focusing on providing cancer patients and oncologists with comprehensive molecular information to revolutionize cancer care. The company specializes in precision medicine, using advanced technologies like molecular profiling and artificial intelligence to understand cancer at a molecular level, offering better treatment options for patients. Caris Life Sciences integrates these technologies with clinical trial solutions and biopharma to enhance cancer research and treatment solutions. Their commitment is to improve as many lives as possible through transformative medical science.

📋 Description

• 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 • Coordinate and conduct regular reviews of study binders and systems to ensure documents are non-expired, complete, and aligned with protocol requirements • Serve as liaison between internal teams, research sites, IRBs, and sponsors • Track study progress, milestones, and document statuses in CTMS, IRB portals, spreadsheets, and sponsor systems • Assist with site onboarding and study activation throughout the trial lifecycle • Participate in internal and external meetings, including site calls and sponsor touchpoints • Support compliance with federal, state, and local regulations, GCP, HIPAA, FDA, OHRP, and other applicable guidelines • Assist with development and delivery of GCP training • Monitor changes in clinical regulatory processes and assist with developing new processes or SOPs

🎯 Requirements

• 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 • Working knowledge of ICH-GCP, FDA, DHHS, and OHRP regulations and guidelines • Experience working with electronic clinical trial management systems (CTMS) • Completion of Good Clinical Practices (GCP), Human Subject Protection, and HIPAA training • Availability to respond to after-hours issues in rare cases where urgent regulatory support is required

🏖️ Benefits

• Highly competitive and inclusive medical, dental and vision coverage options • Health Savings Account for medical expenses and dependent care expenses • Flexible Spending Account to pay for certain out-of-pocket expenses • Paid time off, including: vacation, sick time and holidays • 401k match and Financial Planning tools • LTD and STD insurance coverages, as well as voluntary benefit options • Employee Assistance Program • Pet Insurance • Legal Assistance • Tuition Assistance