Clinical Trial Coordinator I

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As a Clinical Trial Coordinator I, you will play a crucial role in supporting clinical studies by ensuring smooth administrative and operational processes. This position demands excellent organizational skills, a strong understanding of clinical trial procedures, and the ability to work effectively both independently and as part of a team.

Job-related skills

• Excellent technical/IT skills, with the ability to understand technology's impact on studies and effectively use client systems/software.
• Knowledge of ICH GCP, relevant operational procedures, systems, and quality guidelines regarding clinical studies.
• Ability to work independently as well as collaboratively within a team.
• Professional attitude with a strong customer focus (internal and external stakeholders).
• Effective Time Management, particularly for timely safety notifications and eTMF updates.

Job Responsibilities

• Maintain up-to-date information for participating centers, including all contact details.
• Prepare Investigator and Sponsor files (electronic and/or paper) with essential documents for site initiation.
• Assist client study staff in maintaining sponsor files throughout the study lifecycle.
• Manage archiving processes at study conclusion, adhering to client SOPs, policies, and local regulatory requirements.
• Provide administrative support to accelerate the preparation, collation, review, tracking, and filing of all documentation for regulatory and/or ethics committee submissions.
• Support the execution of Confidentiality Agreements, Conflict of Interest forms, and collection of Data Privacy Notices.
• Offer administrative support for contracting processes.
• Provide administrative assistance for investigator site payments, purchase order preparation, and/or task order creation for services.
• Deliver administrative support for vendor oversight, managing local study material, clinical and ancillary supplies distribution, ordering, tracking, storage, and reconciliation.
• Support the development and maintenance of accurate tracking information related to site and supplier contracts, and external costs.
• Ensure accuracy of relevant study systems.
• Set up new employees and site staff on relevant systems and complete necessary documentation.
• Plan, coordinate, and prepare monthly reports such as KPI reports, governance level 1 reports, and financial reviews.
• Handle planning, logistics, and preparation for local Investigator meetings, including travel arrangements and distribution of study-related presentation materials.
• Support Informed Consent management, from template creation to final local versions, in collaboration with the trial manager.
• Actively participate in clinical study teams, engaging in local study meetings to gain study knowledge and fulfill assigned tasks.
• Assist client study staff with various study-related activities: organizing study meetings, scheduling travel, producing meeting minutes, assembling training/study materials, updating contacts, maintaining study documentation (including eTMF filing and review), and preparing documents.
• Demonstrate knowledge of client systems and a willingness to continuously learn and become highly proficient in using evolving client systems and technology.
• Stay current with all changes and required knowledge on ICH GCP and client written standards, attending appropriate training sessions.
• May be responsible for supporting multiple studies simultaneously, requiring appropriate prioritization to meet business needs and ensure timely delivery of results.
• Communicate and work effectively with medical staff/physicians/scientists, who are often senior in their field, respecting their standing within the medical and/or research community.
• Identify issues and escalate them to client study staff for corrective action to ensure smooth and rapid study progress.

Key skills/competency

• Clinical Trial Operations
• ICH GCP Compliance
• Regulatory Submissions
• Administrative Support
• Document Management
• eTMF Management
• Vendor Oversight
• Data Accuracy
• Project Coordination
• Time Management