Job Description

35 Must-Have Qualifications

• 35 years of experience as a Lead Clinical Research Coordinator (site management experience a plus).
• Experience running complex protocols independently (SSU Closeout).
• Ability to perform all regulatory responsibilities for a study, including IRB, logs, and ISF.
• Full proficiency managing studies without hand-holding; cannot depend on others for regulatory or operational processes.
• Phlebotomy experience required.
• Must work fully onsite MondayFriday, 95 (future hybrid possible after demonstrated success).

Lead Clinical Research Coordinator (CRC) / Future Clinical Research Manager

Location: Onsite, MF 9AM5PM

Department: Clinical Research

Reports To: Site Leadership & Principal Investigator

Status: Full-Time, Onsite Only

Overview

We are seeking a highly experienced Lead Clinical Research Coordinator (CRC) who is ready to step into a hybrid role combining hands-on clinical trial execution with growing leadership responsibilities. This individual will serve as the backbone of a new clinical research department , functioning as the only CRC on-site initially, with a clear pathway to build, train, and manage a research team as the program expands.

This is a career-defining role for a CRC who wants to transition into management, site leadership, and future operational oversight .

What This Role Looks Like Day-to-Day

Morning Responsibilities

• Prepare for participant visits, ensuring all required documents, eSource, and study materials are ready.
• Build new eSource templates when needed.
• Greet participants, conduct study visits, review protocols, and perform hands-on clinical procedures (including phlebotomy).
• Serve as the primary point of contact for all participant communication, questions, and study support.

Throughout the Day

• Independently manage trial operations from startup through closeout.
• Maintain compliance with FDA, ICH-GCP, and internal SOPs .
• Organize and maintain regulatory files, source documents, and study logs.
• Actively recruit study participants through EMR searches and site-driven strategies.
• Educate physicians and clinic staff on research processes (e.g., lunch-and-learns).
• Ensure high-quality documentation and readiness for audits or monitoring visits.

Afternoon Responsibilities

• Work directly with a research-nave Principal Investigator, guiding them through study conduct and research standards.
• Begin taking on leadership responsibilities as the department grows:
• Training and onboarding new CRCs
• Delegating tasks and managing workload distribution
• Performing internal QC checks
• Conduct detailed reviews of data, regulatory files, and eSource to ensure completeness and inspection readiness.

End of Day

• Log progress and visit documentation in the CTMS (CRIO).
• Manage study supplies, investigational products, shipments, and inventory.
• Participate in meetings with sponsors, CROs, and site leadership.
• Prepare for upcoming audits, interim monitoring visits, and SIVs.
• Over time, take on advanced responsibilities including budget review, contract support, and financial reconciliation

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