Clinical Trial Specialist

Clinical Trial Specialist

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.

Key Duties and 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.

Competencies & 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.

Physical Demands

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.

Education and Experience Requirements

• 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).

Alert

We are aware of active recruitment scams using the Neurona name, where individuals pose as our recruiters or post fake remote job openings and make fraudulent job offers online. Please note, that we will never make an offer of employment without conducting multiple rounds of face-to-face interviews using secure video-conferencing technology. Additionally, we will never ask candidates to cash checks or make any payment to be considered for a position. If you believe you have been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency (CISA) at to learn how to report it.

This job description is not intended to be exhaustive and may evolve as business needs change. Duties, responsibilities, and activities may be modified or assigned at any time with or without notice.