Clinical Affairs Associate

Argon Medical Devices Inc • Plano, TX

1d

About The Position

The Clinical Affairs Associate supports the execution of investigator‑ and company‑sponsored clinical studies for Argon’s device portfolio, with primary responsibility for Clinical Operations activities and secondary support for broader Clinical Affairs initiatives.
This role functions as an experienced in‑house clinical operations associate, supporting study startup, conduct, and close‑out activities including site activation, essential document management, TMF/eTMF maintenance, study tracking, site communications, vendor coordination, and financial/administrative support under the direction of the Clinical Operations Manager (COM) or Clinical Study Manager (CSM).

Requirements

• Bachelor’s degree (BA/BS) in life sciences, engineering, or related healthcare/scientific discipline required
• Minimum of 3 years of relevant experience in clinical research or clinical operations within a medical device, pharmaceutical, biotechnology, CRO, or healthcare environment
• Demonstrated working knowledge of clinical trial operations, including study start‑up, site management, essential document collection, and TMF/eTMF maintenance
• Working knowledge of applicable regulations and standards (e.g., FDA regulations as applicable, GCP/ICH, ISO 14155)
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook) and experience working with clinical systems (eTMF, CTMS, ERP, or similar)

Nice To Haves

• Experience supporting medical device clinical studies (investigator-sponsored and/or company-sponsored) preferred
• Experience collaborating with CROs, CRAs, investigators, and vendors preferred

Responsibilities

• Support site start-up activities for assigned studies (e.g., feasibility/start-up tracking, site contact lists, NDA/CSA coordination, and activation status dashboards)
• Create and maintain study regulatory/essential document templates and support collection, review for completeness, and filing of essential documents (e.g., CVs/licenses, training records; Investigator agreements as applicable) under COM/CSM guidance
• Coordinate submission of clinical trial documentation to central IRB/EC after initial submission by the CSM, as delegated, and track approvals/renewals
• Serve as a point of contact for routine clinical site inquiries; triage questions related to protocol logistics, visit schedules, and eligibility requirements to the COM/CSM as needed
• Maintain and update study tracking tools (e.g., site status, enrollment, monitoring follow-ups, deviations/queries logs, vendor trackers) and provide routine reports/dashboards to study team members

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 251-500 employees