Clinical Trial Coordinator I - FSP

About the role

Join us as a Clinical Trial Coordinator I (CTC I) and assist in the coordination and administration of study activities from start-up to execution and close-out. You will work within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost, and quality objectives. You may also act as a buddy during the onboarding phase and provide training to new staff as needed.

Responsibilities

• Assists in coordination and administration of clinical studies from the start-up to execution and close-out.
• Collects, assists in preparation, reviews, and tracks documents for the application process.
• Assists in timely submission of proper application/documents to EC/IRB and, where appropriate, to Regulatory Authorities for the duration of the study.
• Interfaces with Investigators, external service providers, and CRAs during the document collection process to support effective delivery of a study and its documents.
• Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.
• Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF, including document tracking in accordance with ICH-GCP and local requirements.
• Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF "Inspection Readiness."
• Ensures that all study documents are ready for final archiving and completion of the local part of the eTMF and supports the CRA in the close-out activities for the ISF.
• Contributes to the production and maintenance of study documents, ensuring template and version compliance.
• Creates and/or imports clinical-regulatory documents into the Global Electronic Management System ensuring compliance with the client's authoring guidelines.
• Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards (e.g., Submission Ready Standards).
• Sets up, populates, and accurately maintains information in AstraZeneca tracking and communication tools (e.g., CTMS such as VCV, SharePoint) and supports others in the usage of these systems.
• Prepares and/or supports contract preparation at a site level.
• Prepares/supports/performs Health Care Organisations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations.
• Manages and contributes to coordination and tracking of study materials and equipment.
• Coordinates administrative tasks during the study process, audits, and regulatory inspections, according to company policies and SOPs.
• Leads the practical arrangements and contributes to the preparation of internal and external meetings (e.g., study team meetings, Monitors' meetings, Investigators' meetings).
• Liaises with internal and external participants and/or vendors, in line with international and local codes.
• Prepares, contributes to, and distributes presentation material for meetings, newsletters, and websites.
• Responsible for layout and language control, copying, and distribution of documents.
• Supports with local translation and spell checks in English to/from local language, as required.
• Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country-related e-mails.
• Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study-related documents/material.
• Ensures compliance with the client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health, and Environment).
• Ensures compliance with local, national, and regional legislation, as applicable.
• Additional country-specific tasks might be added depending on local needs.

Requirements

• High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification. Bachelor's degree preferred.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year). In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience will be considered sufficient.

Skills

• Ability to work in a team or independently as required.
• Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
• Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency.
• Strong customer focus.
• Flexibility to reprioritize workload to meet changing project timelines.
• Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution, and closeout.
• Good English language and grammar skills and proficient local language skills as needed.
• Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint), and ability to obtain knowledge and master all clinical trial database systems.
• Ability to successfully complete the organization's clinical training program.
• Self-motivated, positive attitude, and good interpersonal skills.
• Effective oral and written communication skills.
• Good negotiation skills.
• Independent thinker.
• Ability to manage risk and perform risk escalation appropriately.

Environmental Conditions

• Work is performed in an office/laboratory/clinical and/or home office environment with exposure to electrical office equipment.
• Occasional drives to site locations.
• Potential occasional travel required.

Schedule

Standard (Mon-Fri)