Associate Director Clinical Operations

Pragmatic; South Carolina; Remote; USD 100,000 - 130,000; Full time

Benefits offered by this job

Annual bonus

Remote role with travel expenses reimb

401(k) with company match

Career pathway to senior leadership

Job summary

IDE Medical Device Trials is seeking an Associate Director of Clinical Operations to lead its CRC teams across multiple sites, reporting to the VP of Clinical Operations. This hands-on leadership role oversees start-up through close-out of IDE vascular and specialty device studies, with remote work on East Coast and ~50% travel.

You'll mentor CRCs, collaborate with investigators, ensure compliance with GCP and 21 CFR 812, manage enrollment and site performance, and drive study timelines and

Qualifications

• IDE medical device clinical trials experience is required.
• 2+ years in people leadership (CRC/CRA or site research team).
• 5+ years in clinical research, site-side, sponsor or CRO.
• Strong knowledge of GCP and FDA device regulations.
• Able to travel ~50% and work remotely.

Responsibilities

• Lead and develop Clinical Research Coordinators across multiple sites.
• Oversee site operations for IDE medical device studies: start-up, enrollment, monitoring, close-out.
• Collaborate with Principal Investigators and physicians on enrollment and site performance.
• Escalate issues to sponsors when needed.
• Monitor enrollment, budgets, contracts, and feasibility for new studies.
• Ensure adherence to GCP and IDE regulations (21 CFR 812).
• Travel to sites ~50% and provide on-site support as needed.

Skills

Leadership of CRC teams

GCP knowledge

FDA device regulations knowledge

Budgeting and contracts

Stakeholder management

Mentoring and coaching

Job description

Associate Director, Clinical Operations | IDE Medical Device Trials | Remote (East Coast) | $100K–$130K + bonus

A growing clinical research network running IDE medical device trials needs an Associate Director of Clinical Operations to lead its coordinator teams across multiple sites. You'll report directly to the VP of Clinical Operations, with a clear path into senior leadership as the network grows.

Location

Remote. Open to candidates in NC, SC, VA, FL, PA, MD, GA or TN within easy reach of a major airport. About 50% travel to East Coast research sites.

The role

You'll own day-to-day clinical operations across a network of vascular and specialty research sites. It's a hands-on leadership role: building and coaching CRC teams, working with investigators to solve problems, and keeping device studies on track from 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 elevate 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

Requirements

• 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
• Based within easy reach of a major airport and comfortable with about 50% travel

Nice to have

• 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

What's on offer

• $100,000 – $130,000 base salary + annual bonus
• 401(k) with company match
• Direct report to the VP of Clinical Operations, with a path into senior leadership
• Join a growing network early
• Remote role with travel expenses reimbursed