Clinical Study Administrator (CSA)

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organization's.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

ICON Bulgaria are currently recruiting for an experienced  Clinical Trial Administrators to work on a range of key therapy areas of Cardiovascular, Renal & Metabolism and Respiratory & Immunology and Vaccines & Immune Therapies.

This particular role is a client dedicated one where you will work exclusively on one sponsors trials and SOPs; you will work for a client that values their staff and puts an emphasis on career development.

The Clinical Study Administrator will assist 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.

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 Clinical Research Associates 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 Local Study Managers 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 (e.g. ANGEL) ensuring compliance with the Authoring Guide for Regulatory Documents.

• 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 tracking and communication tools (e.g. CTMS such as IMPACT, 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.

• 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.

To be successful in the role, you will have:

• University degree
• Minimum 1 year of experience as a CTA gained at CRO or pharmaceutical company or experience in a similar role in clinical trials
• Experience conducting all types of MVs such as: Site Selection, Initiation, Routine Monitoring and Close Out Visits both remotely and on-site
• A demonstrated working knowledge of ICH/GCP Guidelines

• Proven organizational and administrative skills.

• Computer proficiency.

• Good knowledge of spoken and written English.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

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