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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