Senior Clinical Research Coordinator

Pragmatic; West Orange (NJ); On-site; USD 55,000 - 85,000; Full time

Job summary

Pragmatic in West Orange, NJ is hiring a Clinical Research Coordinator (CRC) or Senior CRC to lead IDE and post-market medical device trials at the site, working directly with physicians in a fast-growing clinical research network.

You’ll own studies day-to-day, coordinate visits and data entry, and partner with sponsors while occasionally traveling to nearby New Jersey sites as needed. IDE experience and strong ICH-GCP knowledge are essential.

Qualifications

• IDE or medical device trial experience required for both levels.
• Knowledge of ICH-GCP and FDA regulations is essential.
• 2+ years CRC experience for CRC; 4+ years for Senior CRC.
• Hands-on IDE trials in vascular and endovascular medicine.

Responsibilities

• Screen, consent and enroll patients into device trials (ICH-GCP).
• Coordinate study visits, procedures and follow-up within protocol windows.
• Enter data and resolve queries in EDC systems.
• Prepare for and host sponsor monitoring visits.
• Be the go-to contact for physicians, clinic staff and sponsors.
• Lead studies from site start-up through close-out (Senior CRC).
• Train and support newer coordinators across the network (Senior CRC).
• Act as the main point of contact for sponsors and CRAs (Senior CRC).
• Help shape site processes as the network grows (Senior CRC).

Skills

Clinical Research

ICH-GCP

FDA regulations

Physician interaction

Independent work

Tools

EDC systems

Job description

Want to run FDA IDE device trials hands-on, in a physician practice, without the commute into the city?

Our client, a fast-growing clinical research network, runs FDA-regulated IDE and post-market medical device trials with leading vascular and endovascular practices. They're hiring a Clinical Research Coordinator or Senior Clinical Research Coordinator based at their West Orange, NJ site, a short commute from Montclair, Livingston, Maplewood, Morristown and most of Essex, Morris and Bergen counties.

You’ll be the research lead at the site: working directly with the physicians, owning your studies day to day, and growing with a network that’s expanding fast. Occasional travel to nearby sites in New Jersey when studies need it.

What you'll do

• Screen, consent and enroll patients into device trials (ICH-GCP)
• Coordinate study visits, procedures and follow-up within protocol windows
• Enter data and resolve queries in EDC systems
• Prepare for and host sponsor monitoring visits
• Be the go-to contact for physicians, clinic staff and sponsors

Senior CRCs will also

• Lead studies from site start-up through close-out
• Train and support newer coordinators across the network
• Act as the main point of contact for sponsors and CRAs
• Help shape site processes as the network grows

What you'll bring

• CRC: 2+ years as a Clinical Research Coordinator
• Senior CRC: 4+ years as a coordinator, running device studies independently
• IDE or medical device trial experience (required for both levels)
• Working knowledge of ICH-GCP and FDA regulations
• Confidence working directly with physicians and patients
• Organized, reliable and comfortable working independently
• Hands-on IDE trials in vascular and endovascular medicine
• Real ownership of your site and studies
• Clear path from CRC to Senior CRC as the network grows
• Base $55,000–$85,000 depending on level and experience