Clinical Trial Coordinator II

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. The Clinical Trial Coordinator I (CTC I) assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives. you may act as a buddy during the onboarding phase and provide training to new staff as needed. Essential Duties & 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 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 i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities. • Sets-up, populates and accurately maintains information in AstraZeneca tracking and communication tools (e.g. CTMS such as VCV, SharePoint, etc) and supports others in the usage of these systems (with the exception of countries where there is a specific role dedicated to set up and update the systems). • Prepares and/or supports contract preparation at a site level (with the exception of countries where there is a specific role dedicated to preparing site contracts). • 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 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. Education and Experience

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).

• Showcase a Quantified Excel Portfolio: Build a one‑page “Clinical Trial Tracker” spreadsheet that includes sample data (e.g., subject enrollment, visit compliance, AE reporting) with pivot tables, conditional formatting, and macros you’ve written. Upload this as a PDF link in your application and be ready to walk the interviewers through the file to demonstrate both Excel mastery and trial‑management insight.
• Align with Thermo Fisher’s “Science‑First” Culture: Research Thermo Fisher’s recent press releases on oncology and COVID‑19 trials. In your cover letter and interview, reference a specific study they supported and explain how your experience coordinating multi‑site monitoring visits or eTMF uploads would directly accelerate that program’s timeline.
• Prepare STAR Stories Focused on Remote Coordination: Identify three past projects where you managed a study end‑to‑end while working off‑site (e.g., virtual site initiation, remote source data verification). Structure each response with Situation, Task, Action, Result, highlighting tools you used (MS Teams, SharePoint, CTMS) and measurable outcomes such as a 15 % reduction in query turnaround time.
• Create a Mini‑Case Study for the Interview: Before the interview, draft a 2‑slide deck titled “Optimizing Enrollment for a Phase II Oncology Trial in LATAM.” Include a brief gap analysis, a sample Excel enrollment forecast, and a remote‑monitoring plan. Offer to share the deck during the interview to demonstrate proactive problem‑solving and familiarity with the Latin American regulatory environment.
• Negotiate with Local Market Data and Remote Allowances: Use salary data from Glassdoor, LinkedIn, and local Colombian HR surveys for “Clinical Trial Coordinator II” roles (≈ COP 45‑55 M annually). Factor in Thermo Fisher’s remote‑work stipend (internet, cowork‑space) and ask explicitly about a technology allowance and performance‑based bonus structure. Present your research confidently to justify a target range that reflects both market rates and the added value of your Excel automation expertise.