Location: U.S. – Hybrid role with a preferred home base in the Boston/MA area. Remote applicants within the U.S. will also be considered.
Description
This position will support the administrative activities involved in the execution of clinical trial activities for the Clinical department. We are seeking a detail-oriented and proactive Clinical Administrator to support the execution of cardiovascular medical device clinical trials. This position plays a vital role in ensuring smooth day-to-day operations of clinical studies by providing administrative, logistical, and documentation support to the Clinical team and study sites. This role will also involve regular interaction with the corporate office based in Ireland regarding regulatory and operational matters.
Responsibilities
- Study Operations & Documentation:
- Support day-to-day clinical trial activities, including study setup, execution, and closeout, in compliance with FDA, GCP, and company SOPs.
- Maintain accurate and up-to-date trial documentation, including Trial Master File (TMF), regulatory binders, and study trackers.
- Track study metrics, enrollment logs, and investigator payments; assist in generating internal reports for study performance and data quality.
- Assist with Institutional Review Board (IRB) submissions, approvals, and renewals.
- Cross-functional Coordination & Site Support:
- Serve as a liaison and regularly interact with internal teams, including Clinical, R&D, Regulatory, Quality, and Finance, as well as external stakeholders such as clinical site personnel, investigators, and vendors.
- Coordinate logistics for internal and external team meetings, investigator meetings, training sessions, and site initiation visits.
- Manage procurement of trial-related equipment and supplies, including oversight of the Sales Order process.
- Financial & Compliance Oversight:
- Lead purchase order, invoice, and accrual management to support clinical budgets.
- Ensure audit and inspection readiness through consistent and organized record-keeping.
- Maintain compliance with the FIRE1 Quality Management System and actively engage in quality improvement initiatives to support the achievement of business quality objectives.
- Additional Responsibilities:
- Manage travel logistics for clinical team members attending site visits and conferences.
- Provide support in the development of technical documents, quality procedures, and operational processes related to the clinical development plan.
Qualifications & Experience
- Bachelor’s degree with 2+ years of experience in clinical research, medical device, or another regulated healthcare environment, or an equivalent combination of education and experience.
- Strong organizational, analytical, and problem-solving skills in a compliance-driven environment.
- Excellent communication skills, including strong English language proficiency and the ability to effectively engage with individuals at all levels of the organization.
- Proficiency in Microsoft Office (Excel, Word, Outlook, PowerPoint).
- Ability to handle confidential information with discretion and professionalism.
- Exceptional attention to detail, time management, and organizational skills.
- Self-starter with the ability to take initiative and assume responsibility.
- Flexibility for occasional after-hours work to support global study timelines.
Benefits
- Medical
- Dental
- 401k
- Vacation/Holidays