Clinical Research Site Manager

Clinical Research Site Manager (Coordinator + Business Development)

Overview

Azul BioResearch LLC is an independent clinical research site building a high-performing pipeline in cardiology and specialty trials. We are hiring a hands-on Site Manager who can own daily trial execution while also driving sponsor/CRO relationships, feasibility, and start-up activities. This role requires urgency, strong follow-through, and the ability to operate independently.

Key Responsibilities

Site Operations and Study Execution

• Serve as lead coordinator for assigned trials from feasibility through close-out

• Manage screening, enrollment, visit scheduling, source documentation, EDC entry, query resolution, and TMF/regulatory filing

• Coordinate patient retention, visit window compliance, and protocol adherence

• Support monitoring visits, audits, and inspections; manage CAPAs and follow-up items

• Coordinate lab shipments, imaging, specialty procedures, and outside vendors required by protocol

Start-Up and Regulatory

• Lead feasibility questionnaires, site qualification visits (SQV), SIV readiness, and activation tasks

• Build and maintain study binders, delegation logs, training logs, equipment calibration logs, and site SOP adherence

• Coordinate central IRB submissions, continuing review, amendments, safety letters, and reporting requirements

Business Development and Study Acquisition

• Build and maintain a sponsor/CRO pipeline with documented outreach, follow-ups, and meeting cadence

• Proactively identify trials aligned to our PI specialties and site capabilities

• Maintain a study pipeline dashboard with weekly KPIs and a clear status for each opportunity

• Coordinate sponsor/CRO intro meetings, capabilities presentations, and rapid response to feasibility requests

• Work with leadership to refine site capabilities, vendor readiness, and turnaround times to increase selection likelihood

Success Metrics (KPIs)

• Weekly outreach activity and follow-up completion rate (tracked in a pipeline dashboard)

• Number of feasibility requests completed on time

• Time from feasibility request to submission

• Number of sponsor/CRO intro meetings scheduled per month

• Study start-up task completion timeliness and reduction of activation delays

• Data quality metrics: query aging, EDC timeliness, monitoring findings closure rate

Required Qualifications

• 3+ years clinical research experience in a site setting (CRC, start-up, or site management)

• Demonstrated ability to manage multiple studies and deadlines without close supervision

• Strong sponsor/CRO communication skills and comfort leading calls

• Working knowledge of GCP, informed consent, AE documentation, essential documents, and monitoring workflows

• Strong operational organization: trackers, dashboards, documentation control

Preferred Qualifications

• Prior experience driving feasibility and study acquisition or supporting site growth initiatives

• Experience with cardiology, nephrology, or specialty trials is a plus

• Experience coordinating external vendors (imaging, CPET, ophthalmology, specialty labs)

• CTMS, eTMF, EDC familiarity (Medidata, Veeva, Florence, or similar)

What We Offer

• Competitive compensation (based on experience)

• High-growth environment with direct access to physician leadership

• Opportunity to build a research site footprint and pipeline from the ground up

How to Apply

Please send your resume and a short summary answering:

1. What trials have you supported end-to-end

2. Your experience with feasibility, start-up, and sponsor/CRO communication

3. Examples of how you track pipeline and weekly KPIs