Clinical Trial Associate - Home-Based (East Coast)

As a Clinical Trial Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

• Work on Clinical Trials by assisting the Clinical Trial Manager(s) (CTM) with the conduct of the assigned clinical trial(s) (eg administration, coordination, and archiving)
• Assist with the inspection readiness of the Electronic Clinical Operations system (ECO) for their assigned trials
• Provide support to the Clinical Trial Team (CTT) (eg ECO support, training matrix, minute taking, and/or creation of trackers, system access management)
• Help the Global Head of Trial Operations with the logistics of the departmental meetings (eg minute taking)
• 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.
• Act as Business Administrator in the eTMF system, by maintaining records and supporting close-out activities (including archival preparation) in the eTMF system. This includes: managing study records, country records and site records.
• 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
• Assist 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
• Assist with other Trial Operations related activities based on relevant experience

• Bachelor’s degree or University degree – medical, para-medical, or equivalent by experience
• Minimum of 1 year of experience in a similar position within Clinical Operations (CTA)
• 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 (eg Electronic Case Report Form (eCRF), Interactive Response Technology (IRT), Interactive Voice/Web Response System (IXRS), and Veeva Vault)
• 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

Why 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.

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.

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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

**Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.**