Note: The job is a remote job and is open to candidates in USA. Pragmatic Resource is conducting a search for an unnamed growing clinical research network. The Associate Director of Clinical Operations will lead coordinator teams and oversee day-to-day operations across multiple sites conducting IDE medical device trials, from study start-up through close-out.

Responsibilities

• Lead, mentor and manage Clinical Research Coordinators (CRCs) across multiple sites
• Oversee site operations for IDE medical device studies: start-up, enrollment, monitoring visits and close-out
• Work with Principal Investigators and physicians on enrollment, protocol deviations and site performance
• Act as escalation point for sites and sponsors, and know when to escalate further
• Track enrollment, site metrics, budgets and contracts, and support feasibility for new studies
• Make sure sites follow GCP, the IDE regulations (21 CFR 812) and sponsor protocols
• Travel to sites about 50% of the time and step in on site when needed

Skills

• Hands-on experience with IDE medical device clinical trials (required)
• 2+ years leading or managing people, ideally CRCs, CRAs or a site research team
• 5+ years in clinical research, site-side, sponsor or CRO
• Strong working knowledge of GCP and FDA device regulations
• Confidence working directly with physicians and PIs
• Business sense across budgets, clinical trial agreements, enrollment and feasibility
• Vascular, endovascular, cardiology or interventional trial experience
• Experience at a multi-site research network or SMO
• Experience as a CRA, Research Manager or Clinical Operations Manager
• CCRP, CCRC or CCRA certification

Benefits

• Annual bonus
• 401(k) with company match
• Direct report to the VP of Clinical Operations, with a path into senior leadership
• Remote role with travel expenses reimbursed

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