Clinical Trial Assistant

Overview

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Responsibilities

This Clinical Trial Invoicing Assistant helps support the SELUTION SLR clinical program spanning across the peripheral/coronary space. This role performs invoicing duties and responsibilities as directed by the clinical study leaders. Clinical research is the top priority for Cordis organization in improving patient care. This role assists the invoicing process throughout the different stages of clinical trials and interacts with healthcare professionals and internal project teams and accounts payable (AP).

Key Accountabilities

• Follow Cordis procedures, processes and protocols
• Support study sites and activities to ensure adherence to appropriate industry US and OUS regulations, compliance with the study Protocol(s), and applicable local regulations
• Assist in coordination of study tasks from start-up phase through study completion
• Maintain internal Trial Master Files (TMFs) and prepare study TMF for audit readiness
• Collect and file study and site documentation and ensure filing in TMF is consistent and accurate
• Ensure proper escalation of site/project invoicing related issues to the Study Lead in a timely manner
• Facilitate invoice processing between clinical vendors and sites with AP and track clinical related invoices
• Provide all required documentation to AP when a new vendor is identified
• Update and maintain Invoice Tracker as invoices are received
• Provide Invoice Request Letters (IRLs) to clinical research sites on a quarterly basis
• Upon receipt of an invoice, check against IRL and contract
• Code invoice, log into tracker and submit invoice to AP
• Review and escalate any questions with study management
• Facilitate questions between clinical sites and AP on status of payments
• Facilitate questions on invoices with the clinical sites

Strategic Impact

• Assist with clinical study management.

Key Interactions

• Supervisor: Sr Director of Clinical Operations
• Internal Interactions: This role will interact heavily with the Clinical Study Managers, data managers and other clinical teammates. Additionally, this role may also interact cross-functionally with Finance, Quality, etc.
• External Customer Interactions: Contract Research Organizations (CROs) and other clinical vendors and sites

Qualifications

Required Skills and Experience

• At minimum, 1 year of experience working on clinical studies with knowledge of conducting studies under ICH and GCP guidelines
• Bachelor’s degree or equivalent education
• Preferably, medical device or other regulated manufacturing industry experience
• Precise, Detail-Oriented with strong work ethic
• Strong communication and listening skills
• Fluent in English
• Ability to read, comprehend, and follow written procedures. Understand and follow verbal instructions.
• Ability to utilize Microsoft and other computer software packages.
• Ability to be able to communicate ideas, problems and solutions to supervisor and management.
• Ability to work alone and in a team environment.
• Raise questions/issues in a prompt manner

Pay / Compensation

The expected pre-tax pay rate for this position is $61,050 - $77,000 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Preferred Qualifications

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammates’ points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.