Clinical Trial Coordinator

Description

WHO WE ARE

We are a growing medical device company developing innovative technology to transform the treatment of mitral valve disease. Our team is advancing a transcatheter mitral valve replacement through pivotal clinical development, with a shared commitment to bringing safe, effective, and innovative technology to patients.

THE OPPORTUNITY

We are seeking a Clinical Coordinator to provide critical coordination and operational support across our Clinical Operations team. This is a highly collaborative role that touches many aspects of clinical trial execution—from site documentation and clinical data to payments, device logistics, meetings, and training.

The ideal candidate is organized, detail-oriented, and comfortable managing multiple priorities while ensuring clinical trial activities remain accurate, timely, and audit-ready.

HOW YOU WILL CONTRIBUTE

Clinical Documentation & Site Support

• Independently track and maintain, site regulatory documentation; including but not limited to regulatory approvals, informed consent, agreements, and reporting requirements.
• Independently track and maintain, site personnel documentation; including but not limited to CVs, trainings, and credentials for study site personnel.
• Independently track and maintain, investigational device accountability and trial procedure documentation.
• Serve as a point of contact for clinical sites on documentation and subject matter expert on documentation.
• Maintain accurate, audit-ready study files in electronic systems.
• Regularly conduct internal review of trial documents maintained by the Sponsor.

Payments & Financial Tracking

• Process payments, invoices, and compensation for sites, core labs, and additional third-party vendors.
• Review invoices according to executed agreements to ensure accuracy. Collaborate with internal and external staff to reconcile financial discrepancies to ensure timely and accurate payment processing.
• Track and maintain payments and provide accrual information to Finance.
• Serve as subject matter expert for internal and external staff for all trial payments and financial tracking.

Device & Trial Materials Logistics Coordination

• Support operations with device & trial materials shipments, returns, and documentation.
• Maintain accurate records of device & trial materials disposition and returns.
• Coordinate with Operations on shipping logistics.
• Independently assemble, maintain, and distribute internal and external trial materials (e.g., subject binders, regulatory binders, recruitment materials).

Meeting & Training Support

• Assist in coordinating investigator, study coordinator, and committee meetings (on-site and remote).
• Assist with travel and logistics when supporting meetings.
• Prepare training materials, track attendance, and engage with site personnel.

General Team Support

• Provide cross-coverage to support other coordinators as workloads shift.
• Contribute to process improvements and team initiatives as needed.

Image & Data Processing

• Coordinate receipt, processing, and tracking of clinical images and related data from sites and core labs.
• Resolve issues with sites and vendors to ensure timely and complete data submissions.
• Maintain image data records in EDC and ensure quality and compliance.

Perform other duties as required for successfully completing studies, as necessary.

Requirements

WHAT YOU NEED TO SUCCEED (MINIMUM QUALIFICATIONS)

• Associate or Bachelor’s degree; a degree in Life Sciences, Chemistry, Healthcare, or a related field is preferred.
• 2–5 years of experience in clinical research, clinical trials, or an FDA-regulated healthcare environment.
• Working knowledge of clinical trial documentation requirements and clinical research operations.
• Strong organizational skills with the ability to manage multiple priorities and deadlines.
• Proficiency with Microsoft Office, including Excel, Word, PowerPoint, and Outlook.
• Strong attention to detail, accuracy, and follow-through.
• Clear and professional communication skills with the ability to build positive relationships with clinical sites, vendors, and internal teams.
• Ability to travel up to 10%.

WHAT WILL SET YOU APART (COMPETENCIES)

• Experience working directly with clinical research sites, core laboratories, or clinical trial vendors.
• Experience with EDC systems or clinical trial databases.
• Experience tracking clinical images or other clinical trial data.
• Familiarity with clinical trial payments, contracts, invoices, or financial tracking.
• Experience supporting investigator meetings, site training, or other clinical study meetings.
• Strong problem-solving skills and the ability to proactively resolve issues.
• Highly organized with the ability to shift priorities and provide cross-coverage in a team environment.
• Demonstrated reliability, accountability, and commitment to accurate and timely execution.
• Comfortable working in a fast-paced, evolving environment where priorities can change and team members are expected to take ownership and support one another.

WHY JOIN US

We recognize that meaningful work is supported by meaningful benefits. That’s why we offer a competitive compensation package along with comprehensive benefits designed to support you and your family’s health, well-being, and financial future.Our benefits package includes:

• Medical
• Dental
• Vision
• Flexible Spending Account (FSA)
• Basic Life
• 401(k) Retirement Plan
• Paid Holidays
• PTO
• Maternity/Paternity paid leave

It is 4C Medical’s policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state or local laws.