TMF & Regulatory Documentation Specialist

StartX; Redwood City (CA); Hybrid; USD 61,000 - 91,000; Full time

Job summary

Karius is seeking a Clinical Trial Associate to support CRAs and study teams by collecting, QCing, and QAing regulatory documents and by helping to set up and maintain the TMF per ICH-GCP. The role focuses on ensuring completeness and timely filing while communicating with sites to obtain missing documents.

The CTA will work under guidance, building proficiency in TMF standards, with travel up to 10-20% and a remote-friendly environment in the Bay Area.

Qualifications

• Bachelor's degree in life sciences, health sciences, clinical research, or related field.
• 1-3 years of experience in clinical research, clinical operations, or regulatory documentation.
• Familiarity with TMFs/ISFs or ability to learn TMF processes.
• Basic knowledge of ICH-GCP, FDA regulations, and related requirements.

Responsibilities

• Assist study teams with collection, QC, and QA of regulatory documents.
• Support TMF setup and maintenance per sponsor SOPs and ICH-GCP.
• Maintain TMF and ISF filings accurately and timely.
• Identify gaps in TMF and track outstanding documents across studies.

Skills

Attention to detail

Organizational skills

Communication skills

Time management

Team collaboration

Problem solving

Adaptability

Education

Bachelor's degree in life sciences

Tools

Google Workspace

Microsoft Office

Job description

About Karius

Karius is a life science, venture-backed clinical metagenomics company, focused on elevating patient care through microbial insights. We are committed to advancing diagnostic science and technology to optimize the diagnosis and treatment of infectious diseases. Through the use of genomics and AI, we are driven to improve the diagnostic landscape for infectious diseases. Karius delivers unprecedented diagnostic insight detecting microbial cell-free DNA circulating in the body to assist physicians to make rapid treatment decisions.

Position Summary:

The Clinical Trial Associate (CTA) supports CRAs, and study teams across Karius clinical studies by assisting with the collection, quality control, and quality assurance of study and trial related regulatory documentation, and by helping to set up and maintain the Trial Master File (TMF) in accordance with ICH-GCP and applicable regulatory requirements. The CTA helps ensure that study and trial related regulatory documents are collected and filed accurately, supports identification of gaps in the TMF, and helps communicate with sites and study teams to obtain outstanding documents. The CTA works under the guidance of the study team while building proficiency with TMF standards and documentation practices.

Why Should You Join Us?

Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company's platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The products Karius offers today are some of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our tests are the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale.

Reports to:Sr. Manager, Clinical Site Operations

Location: Remote (Bay Area preferred)

Primary Responsibilities:

• Assist study teams with the collection, quality control (QC), and quality assurance (QA) of study and trial-related regulatory documents.

• Support the setup and maintenance of the Trial Master File (TMF) in accordance with sponsor SOPs, the TMF Reference Model, and applicable regulatory requirements, including ICH-GCP.

• Help ensure study and trial-related regulatory documents are collected, reviewed, filed, and maintained accurately and in a timely manner within the TMF.

• Perform routine QC and QA reviews of TMF documentation under guidance to confirm completeness, accuracy, and appropriate filing.

• Assist in identifying gaps in the TMF and tracking outstanding or missing documents across assigned studies through resolution.

• Communicate with clinical sites and study teams, under guidance, to request and follow up on outstanding or missing regulatory documents.

• Support the maintenance of Investigator Site Files (ISFs) in coordination with site staff and study teams.

• Assist with the development and maintenance of study templates, trackers, forms, and other study tools.

• Maintain study trackers, documentation, and shared study materials using Google Workspace tools, including Google Sheets, Docs, and Drive.

• Assist with the preparation and organization of TMF and ISF documentation for audits and inspections.

• Support investigator meeting planning, coordination, and logistics, including preparation of meeting materials and follow-up activities.

• Maintain study communication and distribution lists to support timely and accurate communication with study teams and clinical sites.

• Support study start-up activities, including the collection and tracking of required site and regulatory documentation.

• Assist with tracking study milestones, deliverables, and action items and follow up with appropriate team members as needed.

• Support the preparation, organization, and distribution of study-related materials and documentation.

• Assist with study meeting coordination, including scheduling, preparing agendas and materials, documenting meeting notes, and tracking action items.

• Support document archiving and study closeout activities to help ensure required documentation is complete and appropriately maintained.

• Provide administrative and operational support to clinical study teams based on study needs.

• May support additional activities and responsibilities as study needs require.

What's Fun About the Job?

Karius is operating at the edge of what is now known to be possible in diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don't suffice. You will get to see how much your work really matters.

Travel: Travel required up to 10-20%

Physical Requirements:

Subject to extended periods of sitting and/or computer use. Work is generally performed in an office, laboratory, clinical site or remote home office environment.

Position Requirements:

• Bachelor's degree in life sciences, health sciences, clinical research, or a related field, or an equivalent combination of education and experience.

• 1-3 years of experience in clinical research, clinical operations, regulatory documentation, or a related environment.

• Basic understanding of clinical research processes and the role of study documentation in supporting compliant clinical trial execution.

• Familiarity with Trial Master Files (TMFs), Investigator Site Files (ISFs), or other clinical study documentation systems, or the ability to quickly learn applicable processes and standards.

• Basic knowledge of, or willingness to learn, ICH-GCP, FDA regulations, and other applicable clinical research requirements; familiarity with ISO standards and CLIA requirements is a plus.

• Familiarity with medical and clinical research terminology, or demonstrated ability to learn technical terminology quickly.

• Strong attention to detail, with the ability to review documentation for completeness, accuracy, consistency, and appropriate filing, and to identify and escalate missing or incomplete information.

• Strong organizational and time management skills, with the ability to manage multiple tasks, maintain study trackers, follow up on outstanding items, and meet established timelines.

• Strong written and verbal communication skills, with the ability to build effective working relationships with CRAs and study teams, clinical sites, and cross-functional partners.

• Ability to follow established procedures, incorporate feedback, and work effectively under guidance while building greater independence and proficiency over time.

• Demonstrated accountability, reliability, and follow-through in completing assigned responsibilities and maintaining accurate study documentation.

• Proficiency with Microsoft Office Suite and Google Workspace, with the ability to learn clinical research systems and document management platforms.

• Ability to work effectively in a collaborative, fast-paced environment while maintaining accuracy, confidentiality, and attention to detail.

• Preferred: Exposure to clinical studies in infectious disease, microbiology, molecular diagnostics, genomics, or related life sciences.

• Preferred: Familiarity with electronic Trial Master File (eTMF) platforms.

Personal Qualifications:

• Strong attention to detail and commitment to accuracy and quality.

• Sound problem-solving skills and willingness to learn and develop new capabilities.

• Demonstrated accountability, integrity, reliability, and follow-through.

• Ability to remain composed and organized in a fast-paced, high-intensity environment.

• Collaborative team player who builds trusted working relationships with Senior CTAs, CRAs, study teams, and site staff.

• Ability to receive guidance and feedback and apply it effectively.

• Strong commitment to maintaining accurate, complete, and inspection-ready study documentation.

• Motivated by the opportunity to contribute to meaningful improvements in patient care through high-quality clinical research.

Disclaimer

The above job description is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. Responsibilities and duties may change or be adjusted to meet the needs of the company, and additional duties may be assigned as necessary. The job description is subject to change at any time at the discretion of Karius. Note that job duties and responsibilities may evolve based on company needs and technological advancements.

At Karius, we value a diverse and inclusive workplace and provide equal employment opportunities for all applicants and employees and are committed to honor and invest in the full diversity of people, in our hiring, recruiting and development of employees across the Company. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual's race, color, sex, gender identity and gender expression (including transgender individuals who are transitioning, have transitioned, or are perceived to be transitioning to the gender with which they identify), religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application due to a disability, please contact us at [e-mail] and we will accommodate qualified individuals with disabilities.

$60,842 - $91,264 a year