Clinical Trial Associate

Position Overview

The Clinical Trial Associate (CTA) will serve as a key contact for the study team, facilitating the planning, implementation, and completion of both outsourced and internal clinical research projects. This role requires independent handling of daily study-related documentation, tracking, and coordination tasks, with appropriate escalation to other departments like Regulatory Affairs, Clinical Operations, and Data Management when necessary.

Key Responsibilities

• Manage the setup, upkeep, quality verification, and closure of the Trial Master File (TMF) and electronic TMF (eTMF).
• Monitor and maintain essential study documents such as CVs, FDA Form 1572s, laboratory accreditations, IRB/IEC approvals, and contracts with sites or vendors.
• Ensure the TMF remains comprehensive, accurate, and ready for inspections throughout all study phases.
• Keep study metrics current, including monitoring visit reports, regulatory trackers, and contact lists.
• Organize agendas and record minutes for study team meetings.
• Assist with logistical planning and execution of investigator meetings and monitor workshops, including preparing materials and managing follow-ups.
• Collaborate with Regulatory Affairs for document handovers, submission timelines, and deadline management.
• Support data reconciliation and clinical data review to uphold study quality standards.
• Update and manage public clinical trial registries like ClinicalTrials.gov and EudraCT/CTIS for compliance and accuracy.
• Act as an intermediary between study teams, CROs, vendors, and internal departments to facilitate seamless study progress.
• Identify and escalate any documentation or regulatory delays or problems as needed.
• Provide general assistance throughout study startup, conduct, and close-out phases.

Eligibility & Qualifications

• Minimum of two years’ experience in biotechnology, pharmaceuticals, or clinical trial support with sponsors or CROs.
• Bachelor’s degree in a scientific field such as life sciences, biology, or chemistry.
• Proficient understanding of TMF and eTMF systems in line with ICH-GCP essential document standards.
• Excellent organizational skills with meticulous attention to detail.
• Capable of independently managing multiple deadlines and priorities.
• Strong verbal and written communication abilities.
• Willing and able to travel up to 30% of the time.

Preferred Skills and Experience

• Familiarity with eTMF platforms such as Veeva Vault or MasterControl.
• Knowledge of clinical trial disclosure requirements for registries like ClinicalTrials.gov and EudraCT/CTIS.
• Experience supporting investigator meetings or training sessions for monitors.
• Exposure to clinical data review and data reconciliation methodologies.