Clinical Trial Specialist
without heading. So we can put physical demands as a paragraph under About the role or separate
without heading. We must preserve all substantive information; do not invent or summarize away detail. So we need to keep physical demands text. Also need to keep "Education And Experience Requirements" content. We must not repeat job title as heading. The job title is "Clinical Trial Specialist". Not to be used as heading. We must not put Job ID/requisition numbers as headings (none present). We need to output only HTML fragment. Structure:
About the role
... include location and description and physical demands maybe.
Responsibilities
- ... each duty
Requirements
... Education and Experience Requirements
Skills
- ... competencies
without heading. Probably better to include as its own
after About the role but before Responsibilities? But we must not create extra headings. So we can just add a
after About the role. Let's extract text. About the role: "Clinical Operations Location: South San Francisco or Remote The Clinical Trial Specialist (CTS) provides operational, administrative, and coordinator support to the Clinical Operations team and plays a pivotal role in the planning, execution, and day-to-day management of clinical trials. Working closely with the Clinical Trial Manager (CTM) or Clinical Operations Lead, this position assists with study execution activities, ensuring clinical trials are conducted efficiently, accurately, and in strict compliance with applicable regulations, Good Clinical Practice (GCP), and company Standard Operating Procedures (SOPs). The ideal candidate is highly organized, detail-oriented, proactive, and adaptable, with a strong ability to manage multiple priorities in a fast-paced biotechnology environment" We also have Physical Demands paragraph: "The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Work is performed in an office environment." We could combine them. Responsibilities list: bullet points under "Key Duties And Responsibilities". Need to capture each duty. Let's extract: - Study Operations & Tracking: Maintain study tracking tools / systems, study logs, enrollment metrics, and cross-functional trackers to support study execution from initiation through close-out. - Meeting Coordination: Coordinate internal and external study meetings, including scheduling, preparing comprehensive agendas, creating tracking materials, taking meeting minutes and maintaining a Decision & Actions Log. - Study Start-Up Support: Assist with study start-up and site activation activities, including generating site tools, reviewing site-specific informed consents, tracking start-up activities, tracking CRO progress, monitoring CRO reported Key Performance Indicators (KPIs) to summarize and/or raise risks to clinical study team. - Vendor Support: Support vendor management activities (e.g. Contract Research Organizations (CROs), central laboratories, and third-party vendors) by monitoring day-to-day timeline deliverables and action items including sample/imaging collection, assistance with communication between stakeholders, and site adherence to protocol assessment schedule. - eTMF Management & Oversight: Lead or assist in oversight of electronic Trial Master File ((e)TMF) health. Perform eTMF quality and completeness checks and communicate findings, such as outstanding documents, filing issues, or quality concerns to CRO for correction. Proactively remind & support clinical study team members to submit site discussion summaries, decision logs, training presentations, etc. to ensure continuous audit and inspection readiness. - Compliance & Problem Solving: Routinely follow internal SOPs, monitor compliance with clinical trial protocols, identify potential operational risks, documentation gaps or protocol deviations, and escalate issues smoothly to the study lead. We need to keep each as
About the role
Clinical Operations Location: South San Francisco or Remote The Clinical Trial Specialist (CTS) provides operational, administrative, and coordinator support to the Clinical Operations team and plays a pivotal role in the planning, execution, and day-to-day management of clinical trials. Working closely with the Clinical Trial Manager (CTM) or Clinical Operations Lead, this position assists with study execution activities, ensuring clinical trials are conducted efficiently, accurately, and in strict compliance with applicable regulations, Good Clinical Practice (GCP), and company Standard Operating Procedures (SOPs). The ideal candidate is highly organized, detail-oriented, proactive, and adaptable, with a strong ability to manage multiple priorities in a fast-paced biotechnology environment.
The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Work is performed in an office environment.
Responsibilities
- Study Operations & Tracking: Maintain study tracking tools / systems, study logs, enrollment metrics, and cross-functional trackers to support study execution from initiation through close-out.
- Meeting Coordination: Coordinate internal and external study meetings, including scheduling, preparing comprehensive agendas, creating tracking materials, taking meeting minutes and maintaining a Decision & Actions Log.
- Study Start-Up Support: Assist with study start-up and site activation activities, including generating site tools, reviewing site-specific informed consents, tracking start-up activities, tracking CRO progress, monitoring CRO reported Key Performance Indicators (KPIs) to summarize and/or raise risks to clinical study team.
- Vendor Support: Support vendor management activities (e.g. Contract Research Organizations (CROs), central laboratories, and third-party vendors) by monitoring day-to-day timeline deliverables and action items including sample/imaging collection, assistance with communication between stakeholders, and site adherence to protocol assessment schedule.
- eTMF Management & Oversight: Lead or assist in oversight of electronic Trial Master File ((e)TMF) health. Perform eTMF quality and completeness checks and communicate findings, such as outstanding documents, filing issues, or quality concerns to CRO for correction. Proactively remind & support clinical study team members to submit site discussion summaries, decision logs, training presentations, etc. to ensure continuous audit and inspection readiness.
- Compliance & Problem Solving: Routinely follow internal SOPs, monitor compliance with clinical trial protocols, identify potential operational risks, documentation gaps or protocol deviations, and escalate issues smoothly to the study lead.
Qualifications
Bachelor’s Degree (BA/BS) or equivalent combination of education and experience, preferably in Life Sciences, physical sciences, nursing, or a related healthcare field. Minimum of 1 to 3 years of direct experience in clinical research within the pharmaceutical, biotechnology, or CRO industry (or equivalent clinical site-based study coordinator experience). Understanding of GCPs, ICH, and knowledge of regulatory requirements and good experience partnering with Clinical Quality Assurance. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and collaborative conferencing platforms (Teams, Zoom).
Skills
- Regulatory Knowledge: Solid working knowledge of clinical drug development processes, clinical trial operations, and applicable guidelines, including ICH-GCP, FDA requirements, and the Code of Federal Regulations.
- Systems Experience: Hands-on experience or familiarity with standard industry clinical trial software systems, specifically eTMF, CTMS, and Electronic Data Capture (EDC) applications.
- Organization & Detail: Exceptional organizational capabilities and a meticulous, high-quality approach to managing documentation and data records.
- Communication: Strong written and verbal communication skills to effectively interface with cross-functional internal teams, clinical sites, and external collaborators.
- Team Dynamics: A collaborative, solution-oriented, and confident "team-player" attitude with the flexibility to adapt within an evolving, fast-moving biotech pipeline environment.
- Learning Agility: Quickly learns new systems, processes, therapeutic areas, and study-specific requirements.