Clinical Trial Assistant

As a member of the Clinical Trial Team (CTT), the Clinical Trial Assistant (CTA) will assist the Clinical Trial Managers (CTM) with the conduct of the assigned clinical trials, including the administration, coordination, and archiving. This person with also assist with the inspection readiness of the Electronic Clinical Operations system (ECO) and will provide support with the training matrix, minute taking, creation of trackers, and system access management for the CTT. The CTA will also assist the Global Head of Trial Operations with the logistics of the departmental meetings.

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre 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.

• Assist the CTM and CTT with the coordination of the logistical aspects of the assigned trial(s), according to Good Clinical Practice (GCP) and the applicable Standard Operation Procedures (SOPs)
• Develop and adapt documents to trial specific requirements in collaboration with the CTM
• Assist with organizing (agenda, meeting minutes, follow-up on action items) trial specific meetings, including but not limited to trial team meetings and Investigator Meetings
• Coordinate the filing of Trial Master File (TMF) documents in the (electronic) Trial Master File (TMF) part of ECO by reviewing completeness and correct use of ECO. Follow-up with the CTT on findings and provide support on how to use ECO
• Assist the CTM/COL to ensure that the Trial Operations TMF Documents are properly filed and made ready for archiving
• Provide logistical support to the CTT on vendor (e)TMF oversight activities
• Support the Global Head of Trial Operations with the development of department template documents and the organization of the departmental meetings (agenda, meeting minutes, follow-up on action items)
• Assist with the preparation of trial reports for the CTT and keep them up-to-date
• Assist with signature collection of Confidentiality Disclosure Agreements, Purchase Orders, and insurance certificates in collaboration with CTM/ Vendor Management
• Help with other Trial Operations related activities based on relevant experience

Skills and Competencies:

• Knowledge of International Conference on Harmonisation - Good Clinical Practice (ICH-GCP)
• Knowledge of Drug Information Association Trial Master File (DIA TMF) reference model
• Proficient in software applications such as Outlook, Word, Excel and PowerPoint
• Experience with tools and systems for managing clinical trials, such as Microsoft Project
• Experience with trial progress and metric systems including, Electronic Case Report Form (eCRF), Interactive Response Technology (IRT), Interactive Voice/Web Response System (IXRS), and Veeva Vault

• Bachelor’s degree in medical or para-medical field, or equivalent experience
• Minimum of 1 year of experience in a similar position within Clinical Operations
• Strong oral and written communication skills; excellent organization skills with the ability to prioritize tasks; ability to work both independently and as part of a multidisciplinary team

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.