Clinical Research Coordinator Lead/Manager - 248029 Job at Medix™, New Orleans, LA

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  • Medix™
  • New Orleans, LA

Job Description

Job Title: Lead Clinical Research Coordinator (CRC)

Location: New Orleans, LA

Schedule: Monday–Friday, 9:00 AM–5:00 PM (On-site)

Type: Contract-to-Hire, 6 month

Pay: $32-$40/hour

Overview

We are seeking an experienced and driven Lead Clinical Research Coordinator to help build and lead a brand-new research department from the ground up. This individual will serve as both a hands-on coordinator and a leader, managing all aspects of clinical trials while guiding a new physician and eventually mentoring a team of CRCs. This is a unique opportunity for someone eager to take ownership, grow into a management role, and be the backbone of a developing clinical research program.

Key Responsibilities

  • Serve as the primary point of contact for all clinical research activities at the site.
  • Perform end-to-end study coordination, from startup and recruitment through closeout.
  • Prepare and manage study documentation, including regulatory binders, source documents, and eSource/CTMS data entry.
  • Conduct participant visits, including consent, assessments, and procedures such as phlebotomy and EKGs as needed.
  • Oversee participant recruitment using EMR systems and community outreach initiatives.
  • Ensure all studies are conducted in compliance with FDA, ICH-GCP, and sponsor requirements.
  • Maintain meticulous documentation and quality control across all studies to ensure audit readiness.
  • Collaborate with and train a new physician principal investigator (PI), providing guidance on research processes and best practices.
  • Lead and mentor future CRC hires, delegating tasks, conducting quality reviews, and maintaining workflow balance.
  • Manage investigational product accountability and study supply inventory.
  • Prepare for and participate in sponsor, CRO, and FDA monitoring visits or audits.
  • Over time, assume expanded responsibilities such as budget negotiations and contract management.

Typical Day Breakdown

  • Morning: Prepare for participant visits, review eSource systems, greet and consent participants, and perform study procedures.
  • Midday: Manage regulatory files, recruitment activities, and communication with the PI and site staff.
  • Afternoon: Conduct quality control reviews, mentor newer staff, and meet with sponsors or prepare for audits.
  • End of Day: Log activities in CTMS, organize documentation, and plan for upcoming study visits.

Qualifications (Must-Have)

  • Minimum of 3 years of experience as a Lead Clinical Research Coordinator .
  • Proven ability to manage complex protocols independently from startup to closeout.
  • Strong regulatory knowledge, including IRB submissions, essential documents, and FDA/ICH-GCP compliance.
  • Fully comfortable in an on-site role (Monday–Friday).
  • Exceptional organizational skills and attention to detail.

Preferred Skills (Nice-to-Haves)

  • Phlebotomy and EKG experience.
  • Prior experience supporting sponsor or FDA audits.
  • Experience training or working with research-naïve PIs.

Why This Role Is Exciting

  • Opportunity to lead and build a new clinical research program from the ground up.
  • Direct mentorship from a physician PI who values work-life balance and flexibility.
  • Clear career growth trajectory into a Research Manager role with team-building responsibility.
  • Supportive and human-centered work environment—understanding that life happens.

This role is ideal for an experienced CRC who thrives in dynamic settings, loves taking initiative, and wants to grow into leadership.

Job Tags

Contract work, Monday to Friday, Day shift,

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