Clinical Trial Specialist

Role Summary

The Clinical Trial Specialist (CTS) is a clinical operations professional who provides comprehensive administrative and operational support to the Clinical Operations team to ensure the successful execution of clinical trials in a rapidly growing biotechnology company. This role supports clinical trials across multiple phases and works closely with the Director of Clinical Operations, Clinical Trial Managers, CROs, vendors, and investigational sites. The CTS plays a supportive role in maintaining inspection-ready documentation in compliance with ICH-GCP, regulatory requirements, and company SOPs.

Responsibilities

• Provide day-to-day operational support for multiple ongoing clinical trials (Phase I–IV) within a biotech setting.
• Support clinical trial start-up, conduct, and close-out activities.
• Review and/or create study documents (e.g. newsletters, and various study / site trackers).
• Collaborate on the management and maintenance of the Trial Master File (TMF/eTMF) in accordance with ICH-GCP and internal SOPs.
• Review, collect, file, and quality-check essential documents from investigational sites, CROs, and vendors. Ensure accuracy and completeness.
• Ensure accurate version control and document completeness to help ensure inspection readiness.
• Support investigational site activation activities, including collection and review of regulatory documentation, as required.
• Coordinate communications with investigational sites, CROs, and vendors.
• Assist with protocol and study-specific training with vendor(s), site personnel and clinical sites.
• Schedule and support internal and external study meetings; prepare agendas and meeting minutes.
• Assist with regulatory submissions, amendments, and ongoing maintenance activities.
• Support audit and inspection readiness activities, including document reconciliation and gap analysis.
• Assist with review and development of study documents and plans (e.g., Protocol, Informed Consent Form (ICF), vendor oversight plans, eCRF guidelines, IRT specifications, user manuals, etc.).
• Ensure compliance with applicable regulations, SOPs, and study plans.
• Maintain accurate data entry and tracking in CTMS, eTMF, and/or other clinical systems.
• May conduct UAT for EDC / IRT and data listing review of EDC data for analysis.
• Track investigator payments, contracts, and vendor invoices.
• Support CRO and vendor onboarding and ongoing oversight activities.

Qualifications

• Solid understanding of clinical trial processes and ICH-GCP guidelines.
• Experience working closely with CROs and investigational sites.
• Experience supporting audits and regulatory inspections.
• Familiarity with FDA and global regulatory requirements.
• Familiarity with the pace and cross-functional nature of a biotech environment.
• Strong organizational skills with exceptional attention to detail.
• Ability to work on multiple studies and manage multiple priorities.
• Strong written and verbal communication skills.

Skills

• Microsoft Office proficiency (Word, Excel, PowerPoint).

Education

• Bachelor’s degree in life sciences, health sciences, or a related field or relevant work experience required.
• Minimum of 2–4 years of clinical trial experience.