Clinical Trial Coordinator I - FSP

Thermo Fisher Scientific•Wilmington, NC

2d•Hybrid

About The Position

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.

Requirements

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
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 organizations clinical training program
Self-motivated, positive attitude and good interpersonal skills
Effective oral and written communication skills
Good interpersonal skills
Essential judgment and decision-making skills
Capable of accurately following project work instructions
Good negotiation skills
Independent thinker
Ability to manage risk and perform risk escalation appropriately

Nice To Haves

Bachelor's degree preferred.

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.